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Biotronik
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Biotronik (BIOTRONIK SE & Co. KG;[1][2] Biotronik Worldwide) is a limited partnership[1] multi-national medical device company, headquartered in Berlin, Germany.

Key Information

The company offers equipment for diagnosis, treatment, and therapy support in the areas of cardiac rhythm management, monitoring, electrophysiology, and neuromodulation.[3] In the area of cardiac rhythm management, Biotronik Home Monitoring uses tele-monitoring technology to provide doctors with up-to-date information for implant patients.[4]

Biotronik employs more than 9,000 people worldwide in over 100 countries, with research and development activities in Europe, North America, and Singapore. It produces all critical components of its products in-house. One in every five employees at its Berlin headquarters works in research and development (R&D).[citation needed]

History

[edit]

BIOTRONIK began with the development of the first German implantable pacemaker (Biotronik IP-03) in 1963. The pacemaker was developed at Technische Universität Berlin by physicist Professor. Dr. Max Schaldach (1936–2001[5]),[6][7] a professor of biomedical technology at the Friedrich-Alexander-University of Erlangen-Nuremberg (FAU),[8] and electrical engineer Otto Franke. In the early years, the company worked to improve pacemakers' capacity and battery life, and secure the connections among electrodes, pacemakers, and the heart. Since its start, more than 19 million BIOTRONIK devices in over 100 countries have been implanted.[citation needed]

In 1976, the company moved to Sieversufer 8 in Britz, Neukölln. In 1979, a US production site in Lake Oswego, Oregon was built. This subsidiary resulted from the acquisition of the American pacemaker producer Stimulation Technology, Inc. At the same time, with the development and production of advanced hybrid circuitry and structural components for the medical technology industry, the company also began to develop circuits for pacemakers. In the 1980s, the dual-chamber stimulation method (DDD) was developed, leading to the manufacturing of a pacemaker that could read and react to spontaneous contractions of the atrium, and better respond to them of its own accord. To this end, BIOTRONIK developed the Diplos 03, a multi-programme DDD pacemaker with bilateral telemetry, which made it a European market leader and increased its presence in South America and Asia.

In 1987, the firm moved its headquarters to Woermannkehre 1, next door to its previous location. In 1993, BIOTRONIK produced the first German implantable cardioverter defibrillator (ICD), among them the Phylax 06. Closed loop stimulation (CLS), which integrates the pacemaker into the body's own regulatory system, thereby allowing it to react to patients’ changing physical and emotional activity, was introduced in the 1990s. Also in 1993, BIOTRONIK developed fractal coating for implantable electrodes. This coating optimises the electrically active surface of the electrode, thereby improving its perception and stimulation properties. BIOTRONIK remains the only manufacturer of fractal-coated electrodes.

BIOTRONIK in the Czech Republic, 2011.

In 1994 and 1995 respectively, BIOTRONIK began offering a full spectrum of electrophysiology products and vascular intervention products. With Philos, the company has offered a complete pacemaker family with telemetry since 2000, when it received CE Mark approval for the product, and also successfully implanted the first pacemaker with Home Monitoring (remote patient monitoring). Home Monitoring has shown significant clinical benefits, including over a 50% reduction in mortality of heart failure patients.[9]

With the Lumax 540 VR-T DX in 2010, BIOTRONIK launched the first and only single-chamber defibrillator with comprehensive atrial diagnostics worldwide. Additionally, the company entered into an exclusive international distribution partnership with the Swiss medical technology company Endosense to distribute their ablation catheter TactiCath with optical contact force. The following year, BIOTRONIK released Orsiro to the market, the world's first hybrid drug-eluting stent with a bio-absorbable coating, adding to innovative treatment options combatting coronary artery disease.[citation needed]

In 2011, BIOTRONIK was the subject of an investigation by the United States Department of Justice (US DoJ) into payments made to doctors in Nevada, United States, who use the company's products in their practices.[10] The case was settled in 2014.[11] In 2013, a similar investigation began and was settled involving payments to physicians in Oregon.[12][13]

The former Postfuhramt, acquired in 2012 by BIOTRONIK.

In 2012, the company acquired the old Postfuhramt, a historical brick postal building on Berlin's Oranienburger Strasse in the sub-neighbourhood of Spandauer Vorstadt, in the district of Mitte.[14]

The following year, BIOTRONIK launched BioMonitor, a type of mini ECG device that offers continuous monitoring and daily remote data collection. In addition, BIOTRONIK also developed the world's first series of implantable defibrillators that enable patients, including those suffering heart failure, to undergo MRI scans under certain conditions. BIOTRONIK's ProMRI® technology includes systems approved for 1.5 T and 3.0 T MR scanning, as well as full-body scanning. The company offers the broadest portfolio of pacemakers, defibrillators, and therapies approved to undergo MRIs, with more than 1,000,000 ProMRI® devices and leads implanted worldwide.[15] To navigate through this portfolio, BIOTRONIK invented two online tools in 2016 and 2017; the ProMRI®SystemCheck and ProMRI®Configurator, correspondingly.

For radiation protection, BIOTRONIK distributes the Zero-Gravity Radiation Protection System, which consists of a movable suspended body and head shield. The shield material has a significantly higher lead equivalency than traditional radiation apparel, thereby reducing radiation exposure by 87–100%.[16]

Indicated to treat peripheral artery disease in the lower limbs, BIOTRONIK released the Passeo-18 Lux in 2014 as the first peripheral drug-coated balloon. The year following, CardioMessenger Smart was launched, its new patient device for Home Monitoring,[17] and BioMonitor 2, the second-generation insertable cardiac monitor.[18]

In February 2016, BIOTRONIK Inc. opened an Education and Innovation Center, a training facility and meeting location in New York City.[19]

In 2023, Biotronik entered the neuromodulation market with the FDA approval of its Prospera™ Spinal Cord Stimulation (SCS) system,. The company simultaneously launched a new business segment, Biotronik Neuro, positioning the firm within the growing non‑opioid chronic pain therapy market.[20]

In February 2025, Biotronik announced a major strategic shift to concentrate on active implantable devices and digital health technologies, including artificial intelligence, remote patient monitoring, and connected‑care platforms. As part of this transition, the company agreed to divest its Vascular Intervention (VI) business to Teleflex, a deal expected to close in 2025.[21] The transaction was completed earlier than anticipated and transferred nearly all of Biotronik’s coronary and peripheral interventional product portfolio—including the Pantera Lux drug‑coated balloon catheter, the PK Papyrus covered coronary stent, and the ultrathin Orsiro Mission drug‑eluting stent—to Teleflex.[22]

Awards

[edit]

In 2007, BIOTRONIK was given the EuroPCR 2007 Novelty Award for its innovative absorbable metal stents (AMS) by the European Association of Percutaneous Cardiovascular Interventions (EAPCI). In 2009, it was nominated for the German Future Prize for its Home Monitoring system by the German Federal Ministry of Education and Research. In 2010, BIOTRONIK endowed the Berlin-Brandenburg Academy of Sciences and Humanities' Technical Science Prize, first awarded to Till Schlösser. The CARDIOSTIM Innovation Award for Practice Improvement was granted to BIOTRONIK for its MRI AutoDetect.[23]

Partnerships

[edit]

BIOTRONIK collaborates with the EPIC Alliance, a global network of female electrophysiologists. The alliance aims to enhance collaboration and support for women in the field of electrophysiology.

In October 2025, Biotronik and the University of Sydney entered a three‑year collaboration to co‑develop digital and connected cardiac‑care solutions. The partnership focuses on remote patient monitoring, AI‑enabled clinical decision support, and scalable digital tools aimed at improving care delivery, particularly for patients in remote or underserved regions. The program will be developed and tested in real‑world clinical settings through 2028.[24]

Business focus

[edit]
  • Cardiac rhythm management: pacemakers, implantable defibrillators, electrodes, cardiac monitors, external monitoring and programming devices
  • Electrophysiology: products for electrophysiological examinations and therapy, including ablation and diagnostic catheters
  • Neuromodulation: products for spinal cord stimulation for chronic pain patients

Headquarters and locations

[edit]

Europe & Middle East

[edit]
Germany
Austria
Belgium
Czech Republic
Denmark
France
Israel
  • Kohav Yair
Italy
Netherlands
Poland
Spain
Switzerland
United Kingdom

Asia

[edit]

North America

[edit]

South America

[edit]

Oceana

[edit]
  • Pymble, New South Wales, Australia

Products and therapies

[edit]
BIOTRONIK ICS 3000 and PK-199
  • Bradycardia therapy
    • Pacemakers (Edora, Evity, Enitra, Enticos, Eluna, Epyra, Etrinsa, Evia, Entovis)
    • Electrodes (Solia, Safio S, Siello, Setrox, Selos)
  • Tachycardia therapy
    • Defibrillators (Rivacor, Acticor, Intica NEO, Ilivia, Inventra, Iperia, Idova, Ilesto,)
    • Electrodes (Linox smart, Protego, Plexa)
  • Electrophysiology
    • Ablation catheters (AlCath Flux eXtra Gold, AlCath Flutter, AlCath)
    • Steerable diagnostic catheters (ViaCath)
    • External devices (Qubic RF, Qubic Stim, Qiona)
  • Cardiac resynchronization
    • CRT defibrillators (Ilivia, Inventra, Ipera, Idova, Ilesto,)
    • CRT pacemakers (Edora, Evity, Enitra, Enticos, Eluna, Epyra, Etrinsa, Entovis, Evia)
    • Electrodes (Corox OTW, Sentus OTW BP, Sentus OTW QP, Sentus OTW QP xx/49)
    • Lead systems and accessories (Selectra, ScoutPro, ScoutPro IC)
    • Guide wires (Streamer, VisionWire)
  • Insertable cardiac monitor (BioMonitor 2, BioMonitor)
  • External devices (Renamic, Reocor, ICS 3000, Reliaty)
  • Patient devices for Home Monitoring (Cardio Messenger, CardioMessenger 2, CardioMessenger Smart)
  • Spinal cord stimulator (Prospera SCS System)

Criticism

[edit]

In 2014, Biotronik faced allegations regarding kickback payments to cardiologists, leading to a settlement of nearly five million dollars.[25][26][27][28] Currently, another case is ongoing in the California Central District Court. Additionally,

In a landmark case from New Mexico in 2016, a jury found Biotronik negligent for unnecessarily implanting a pacemaker in Tommy Sowards due to an alleged conspiracy involving the company, a salesman, a hospital, and a cardiologist. The lawsuit exposed a scheme where Biotronik paid kickbacks to the cardiologist, significantly inflating his earnings per procedure. Despite later advice from medical professionals that the pacemaker was not needed, it could not be removed without risking heart damage. As a result, the jury awarded Sowards $2.3 million in compensatory damages and $65 million in punitive damages.[29]

Biotronik is under investigation in the Netherlands, with inquiries initiated in autumn 2020. This investigation, reported by Der Spiegel and the Dutch newspaper NRC Handelsblad, focuses on suspicions that medical specialists received millions of euros to promote Biotronik products.[30] Over ten residences have been searched, and assets worth 3.1 million euros belonging to medical specialists have been confiscated. Biotronik has not provided comments on these allegations.

In July 2022, Biotronik resolved a prolonged legal dispute in the USA by agreeing to a multimillion dollar settlement. The case involved allegations from two whistleblowers, who were former independent sales representatives, concerning a kick-back scheme. According to the whistleblowers the scheme entailed treating cardiologists to lavish dinners, winery tours, baseball games, strip club visits, and golf outings, sometimes including their spouses or employees.[31] Additionally, cardiologists were allegedly compensated for making brief appearances at international conferences or provided with business class flights. Another aspect of the scheme involved a trainee program where Biotronik employees observed cardiologists during the implantation of ICDs, for which the cardiologists were paid $400.[32][31] Despite concerns raised by the compliance department, the payments continued. The alleged kick-back system, intended to encouraged the use of Biotronik products, occurred between 2013 and 2021. Although Biotronik denied the allegations, they settled with the US authorities without admitting guilt, paying nearly $13 million.[33][34][35][36]

References

[edit]
[edit]
Revisions and contributorsEdit on WikipediaRead on Wikipedia

Biotronik

View on Grokipedia
from Grokipedia

Biotronik SE & Co. KG is a privately held German medical technology company specializing in the development and manufacture of cardiovascular and endovascular devices, including pacemakers, defibrillators, and stents, aimed at treating heart and blood vessel diseases.
Founded in 1963 in Berlin by physicist Max Schaldach and engineer Otto Franke through the creation of Germany's first implantable pacemaker, Biotronik has expanded globally with manufacturing facilities in Germany, Switzerland, Singapore, and the United States, employing around 9,000 people and prioritizing patient well-being through reliable, high-quality innovations.
Under CEO Alexander Uhl, the company continues to advance therapies in cardiac rhythm management and electrophysiology, though its vascular intervention portfolio, excluding certain products, was acquired by Teleflex in July 2025.

History

Founding and Early Innovations (1963–1980s)

Biotronik was founded in 1963 in , , by Max Schaldach, an student at the , and electrical engineer Otto Franke. The duo, motivated by limited access to imported American pacemakers and Schaldach's interest in applying physics to medical challenges, developed Germany's first implantable pacemaker, the IP-3 model, in a small apartment using transistors sourced from the Heinrich Hertz Institute. This device weighed 15 grams and consumed less energy than contemporary international models, marking an early emphasis on and . The first implantation occurred later that year, performed by Prof. Emil Sebastian Bücherl, with the procedure's success validating the technology's viability. Early efforts centered on addressing inherent limitations of 1960s pacemakers, including short battery lives of approximately one year and unreliable lead materials that caused electrode-heart connection failures. Schaldach and Franke worked extended hours to refine and production processes, incorporating Schaldach's conceptual advancements like lithium-based batteries to extend device longevity. These innovations improved pacemaker capacity and reliability, establishing Biotronik's foundation in cardiac rhythm management through iterative enhancements in battery technology and design. By the 1970s and into the , Biotronik advanced toward programmable pacemakers and dual-chamber systems, building on prior experience with dual-chamber stimulation from the . The company developed dual-chamber (DDD) pacemakers capable of sensing and responding to the heart's spontaneous activity, a key milestone following FDA approval in the early that addressed synchronization challenges between atria and ventricles. These developments, alongside ongoing refinements in programmability and lead durability, solidified Biotronik's reputation for technological progress in implantable devices during the period.

Expansion and Key Milestones (1990s–2010s)

In the 1990s, Biotronik broadened its product portfolio beyond pacemakers, entering the (ICD) market in 1993 with the launch of its first ICD, which was noted as the smallest device of its kind at the time. This expansion aligned with the company's emphasis on mimicking physiological functions through bio-compatible designs. By 1995, Biotronik introduced vascular intervention products, including balloon catheters and stents for coronary and peripheral applications, and established manufacturing in to support growing demand. These developments marked a shift toward diversified cardiovascular therapies amid economic challenges, including sustained engagement in markets like through device donations. The 2000s saw Biotronik pioneer with the launch of BIOTRONIK Home Monitoring in , the first wireless system enabling daily automatic data transmission from implanted devices, later gaining CE mark and FDA approval for early detection of clinical events. This innovation reduced clinic visits and improved outcomes in cardiac rhythm management, building on the company's established presence in and . International operations continued to mature, with subsidiaries facilitating adoption in emerging markets. Entering the 2010s, Biotronik advanced device compatibility with through ProMRI technology, enabling MRI-conditional pacemakers, ICDs, and (CRT) devices. In 2011, the company released Orsiro, a hybrid combining a bioabsorbable with for treating coronary artery , demonstrating reduced restenosis rates in clinical evaluations. Key launches included BioMonitor in 2012, a subcutaneous cardiac monitor integrated with Home Monitoring for detection. Expansion efforts culminated in opening an office in that year, enhancing distribution across the region. These milestones reflected Biotronik's focus on technological integration and global scalability, with over 6 million devices implanted worldwide by the decade's end.

Recent Strategic Shifts (2020s)

In February 2025, Biotronik announced a major strategic pivot by agreeing to divest its Vascular Intervention (VI) business—encompassing drug-coated balloons, stents, and related endovascular products—to Incorporated for €760 million (approximately $895 million in cash consideration). The transaction, aimed at streamlining operations and reallocating resources, was completed on July 1, 2025, allowing Biotronik to sharpen its focus on high-growth active implantable devices in cardiac rhythm management, patient monitoring, and . This divestiture reflects a deliberate shift away from peripheral vascular interventions toward core competencies in bio-compatible implants and connected health technologies, amid competitive pressures in the medtech sector. To support this refocus, Biotronik has emphasized investments in integration, including for and expanded remote monitoring platforms like Home Monitoring, which enable proactive patient management for cardiac implantable electronic devices (CIEDs). In parallel, the company pursued targeted partnerships to bolster its CRM portfolio; for instance, a July 2025 collaboration with CardioFocus introduced the Centauri pulsed field ablation (PFA) system across 17 European countries, enhancing non-thermal ablation options for treatment without divesting core assets. Geographic expansion complemented these efforts, with Biotronik inaugurating an hub in on December 1, 2023, to accelerate regional R&D, clinical trials, and for implantable therapies amid rising in emerging economies. Additional alliances, such as a February 2025 distribution agreement with Egg Medical for the EggNest radiation protection system, underscore a commitment to procedural safety in CRM and procedures, aligning with broader efficiency gains post-divestiture. These initiatives position Biotronik to prioritize long-term in patient-centric, tech-enabled implants over diversified vascular portfolios.

Corporate Structure and Operations

Business Focus and Strategic Priorities

Biotronik primarily focuses on developing, manufacturing, and distributing active implantable medical devices for cardiovascular applications, including cardiac rhythm management (CRM) systems such as pacemakers, implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices, alongside patient monitoring and solutions. The company emphasizes technologies that integrate with the to improve , treatment, and prevention of heart and diseases, as well as management through . This patient-centric approach prioritizes device safety, reliability, and long-term efficacy, with a commitment to matching advanced technology to physiological needs. In February 2025, Biotronik announced a strategic refocus on active implantable devices and solutions, divesting its vascular intervention business to to streamline operations and enhance leadership in core areas like CRM, remote monitoring, and emerging therapies such as . This shift aims to allocate resources toward innovation in implantable technologies that address unmet clinical needs, including digital integrations for and to optimize patient outcomes. Strategic priorities include forging alliances for complementary technologies, such as partnerships with for out-of-hospital cardiology tools in 2023 and CardioFocus for pulsed field ablation distribution in in 2025, to expand access without diluting implant-focused expertise. Sustainability forms a key pillar, with Biotronik's 2030 strategy targeting neutrality, practices, and equitable access to high-quality medical devices amid resource constraints. Procurement and supplier selection emphasize and ethical standards aligned with these goals, ensuring for long-term device reliability. Overall, the company's priorities balance technological advancement with operational efficiency, prioritizing verifiable clinical impact over peripheral diversification.

Headquarters and Global Presence

Biotronik SE & Co. KG maintains its corporate headquarters at Woermannkehre 1, 12359 , , in the district, where the company was established and continues core operations including research, development, and administrative functions. This facility serves as the primary hub for strategic decision-making and innovation in cardiovascular and endovascular medical technologies. The company operates globally with a presence in over 70 countries across , , , , and , supported by subsidiaries, sales offices, and representatives to distribute products and provide local support. Biotronik employs approximately 9,000 people worldwide, enabling localized manufacturing, R&D, and customer service tailored to regional regulatory and clinical needs. Manufacturing facilities are strategically located in , , the (including ), and to ensure supply chain efficiency and compliance with international standards. In December 2023, Biotronik opened a 20,000 m² manufacturing and research hub in , enhancing production capacity and R&D capabilities for the region.

European and Middle Eastern Operations

Biotronik's European operations form the core of its global activities, with the company headquartered in , , at Woermannkehre 1, 12359 , where it conducts research, development, manufacturing, and administrative functions. The firm maintains manufacturing sites in and , supporting production of cardiovascular and endovascular devices, alongside sales subsidiaries across the continent, including in (BIOTRONIK Vertriebs-GmbH, ), (BIOTRONIK Belgium S.A., ), , , the , , and . These facilities enable localized distribution, regulatory compliance, and customer support tailored to European markets, with 's site in Baar focusing on sales and logistics. In the , Biotronik operates primarily through BIOTRONIK Middle East FZE, which coordinates sales, distribution, and technical support across the region from its base in , (Office 634, Block B, Business Village, Port Saeed, ). The company established a dedicated presence in the Middle East over 25 years ago, with a new office opened in February 2020 to strengthen regional expansion and service delivery. Operations extend to countries including (via partners like Wateen Medical Company in ), , , and , emphasizing implantation support, training, and device maintenance through local distributors. This structure facilitates in high-growth areas for cardiac rhythm management and vascular interventions, without dedicated in the region.

Asian Operations

BIOTRONIK's Asian operations are coordinated through its regional headquarters, BIOTRONIK Asia Pacific Pte Ltd, located at 165 Way, #07-00, BIOHUB, 349257. This entity oversees sales, distribution, and support for cardiovascular devices including implantable cardioverter defibrillators (ICDs), (CRT) systems, implantable cardiac monitors (ICMs), remote monitoring solutions, pacemakers, and vascular interventions such as balloon angioplasty and stents. On December 1, 2023, BIOTRONIK inaugurated a 20,000 m² Manufacturing and Research Hub in , functioning as the company's primary facility for regional production, , and to support both local and global markets. This expansion builds on an earlier regional office established in in 2012, aimed at accelerating market penetration amid rising demand for medtech solutions in the . The company maintains dedicated subsidiaries and representative offices across key Asian markets, including BIOTRONIK Korea Co., Ltd. in , ; BIOTRONIK (Thailand) Co., Ltd.; BIOTRONIK Medical Devices India Private Ltd. in ; and a of BIOTRONIK Asia Pacific Pte. Ltd. in , . Operations extend to via BIOTRONIK Australia Pty. Ltd., with additional presence in and through localized sales and support structures. These entities focus on , physician training, and device implantation support tailored to regional healthcare needs, contributing to BIOTRONIK's coverage in over 100 countries globally.

North American Operations

Biotronik's North American operations are primarily conducted through its subsidiaries BIOTRONIK, Inc. and BIOTRONIK Canada Inc., focusing on the distribution, manufacturing, , and clinical for cardiovascular devices such as pacemakers, defibrillators, and related therapies. The U.S. operations serve as the regional hub, supporting sales, , and product innovation tailored to North American markets, while adhering to FDA standards for device approval and post-market surveillance. BIOTRONIK, Inc. maintains its North American headquarters and primary manufacturing facility at 6024 Jean Road, 97035, established in 1979 as the company's first U.S. production site. This campus has hosted ongoing (R&D) alongside production activities, with continuous investments expanding capabilities for active implantable devices in cardiac rhythm management. Contact for U.S. operations is available via +1 800-547-0394. In February 2016, Biotronik opened an Education and Innovation Center at 330 Hudson Street, 14th floor, in New York City's neighborhood, dedicated to advanced training programs for electrophysiologists, cardiologists, and healthcare executives, including hands-on fellowships and discussions on cardiac rhythm management trends. In , BIOTRONIK Canada Inc. operates from 240 Chrislea Road, Suite 106, , L4L 8V1, handling local sales, support, and regulatory affairs for the Canadian market, reachable at 416-620-0069 or [email protected]. These facilities collectively enable Biotronik to address regional demands, though the company's vascular intervention portfolio in was largely divested to effective July 1, 2025, shifting emphasis toward core and rhythm management solutions.

South American and Oceanian Operations

Biotronik operates in through subsidiaries focused on distributing cardiovascular implants, vascular intervention devices, and related services, with serving as the primary hub for coordinating regional activities. BIOTRONIK Comercial Médica Ltda., established as the central office for Latin American operations, oversees logistics, sales, and support across the continent, reflecting the company's expansion into emerging markets during the late . Additional subsidiaries include BIOTRONIK S.R.L. in Vicente López, Buenos Aires, which handles local market access and technical support, and an office in Santiago, , at Providencia Alferez Real N°1380, supporting device implantation and patient monitoring in the Andean region. In , Biotronik's presence centers on , where BIOTRONIK Australia Pty. Ltd. manages sales, training, and distribution for cardiac rhythm management and endovascular products across and from its headquarters at Level 4, Building 2, 20 Bridge Street, Pymble, NSW. This office supports clinical trials, physician education, and device servicing in a market emphasizing advanced therapies for and arrhythmias. On October 22, 2025, Biotronik announced a three-year collaboration with the to develop scalable digital health solutions for cardiac disease management, aiming to integrate remote monitoring technologies tailored to regional healthcare needs.

Products and Technologies

Cardiac Rhythm Management Devices

Biotronik's cardiac rhythm management (CRM) portfolio encompasses implantable devices for treating bradycardias, tachyarrhythmias, and , including single- and dual-chamber pacemakers, implantable cardioverter defibrillators (ICDs), defibrillators (CRT-Ds), and implantable loop recorders (ILRs). These devices feature leads for sensing and pacing, with options for MRI-conditional operation under the ProMRI designation, allowing safe scanning at 1.5T and field strengths after specific testing. External programmers and the BIOTRONIK Home Monitoring system support device interrogation, programming, and remote data transmission, alerting clinicians to arrhythmias or device issues via automatic daily checks. Pacemakers, such as the Amvia series introduced in 2023, provide rate-responsive pacing with extended battery life and reduced-size designs for improved patient comfort; models like incorporate closed-loop stimulation to adapt to physiological needs by monitoring intrathoracic impedance. ICDs, including the Acticor VR-T DX model, deliver therapies for via shocks or antitachycardia pacing, enhanced by DX technology for reliable atrial signal detection without a dedicated atrial lead in single-chamber configurations. CRT-Ds synchronize ventricular contractions to address resynchronization needs in patients, with features like multipoint pacing in select models. ILRs, such as BIOMONITOR IV, offer long-term subcutaneous monitoring for detecting infrequent arrhythmias, with a battery life exceeding three years and photoplethysmography integration for activity correlation. Key innovations trace to Biotronik's founding in with the first German pacemaker, evolving to include the E3-series pacemakers for enhanced longevity and the Home Monitoring platform, which has demonstrated reduced mortality in clinical studies by enabling early intervention. Device performance reports indicate high reliability, with returned pacemakers and ICDs primarily showing normal function or elective battery depletion rather than malfunctions. Leads like the Astron series emphasize fracture-resistant designs with silicone-polyurethane insulation for durability. These advancements prioritize longevity, with some ICDs achieving over 10-year projected service life, and integration with for proactive care.

Vascular and Endovascular Solutions

Biotronik developed a range of vascular intervention products designed to restore blood flow in narrowed or blocked coronary and peripheral arteries through minimally invasive procedures. These included drug-eluting , covered , drug-coated balloons, and self-expanding peripheral systems, aimed at treating conditions such as and (PAD). The company's portfolio emphasized thin-strut designs for improved deliverability and reduced restenosis rates, with products like the Orsiro sirolimus-eluting system featuring a 60 μm strut thickness and coating to minimize long-term . In coronary interventions, Biotronik offered the PK Papyrus covered system, a balloon-expandable device with a membrane for sealing acute coronary perforations, available in 17 sizes and compatible with 5 French guiding catheters for enhanced usability in complex cases. The Pantera Lux drug-coated delivered to inhibit neointimal without leaving a permanent , supporting applications in in-stent restenosis and small vessel disease. These systems were supported by accessories such as catheters and guidewires optimized for high-pressure and precise . For peripheral vascular interventions, Biotronik's solutions targeted PAD in iliac, femoral, and below-the-knee arteries, including the Astron self-expanding nitinol system for maintaining vessel patency in oversized deployments and the Passeo-35 DCB for drug-coated in superficial femoral arteries. These devices incorporated technologies like technology for controlled radial force and reduced fracture risk in tortuous . On July 1, 2025, acquired substantially all of Biotronik's vascular intervention business for approximately €760 million, excluding certain IMDS products, transferring these technologies to new ownership while preserving Biotronik's focus on other cardiovascular segments.

Emerging Therapies and Digital Health Integrations

Biotronik has advanced into pulsed field ablation (PFA) therapies through a partnership with CardioFocus announced on July 24, 2025, aimed at expanding access to PFA systems for atrial fibrillation treatment in Europe, leveraging non-thermal energy to selectively ablate cardiac tissue while minimizing damage to surrounding structures. This collaboration builds on PFA's potential for safer, more efficient ablation compared to traditional radiofrequency methods, with Biotronik integrating the technology into its cardiovascular portfolio. Additionally, on October 9, 2025, Biotronik achieved the world's first implant of a cardiac resynchronization therapy defibrillator (CRT-D) optimized for left bundle branch area pacing (LBBAP), an emerging physiological pacing technique that activates the heart's natural conduction system more effectively than conventional right ventricular pacing, potentially reducing heart failure progression in eligible patients. In , Biotronik's Resonance system employs a multiphase , with data from the BENEFIT-02 published on October 6, 2023, demonstrating its effectiveness in targeted neural activation for management, distinguishing it from single-phase approaches by improving specificity and reducing off-target effects. These therapies reflect Biotronik's strategic refocus on innovative implantables, including and neuromodulation solutions, as outlined in industry analyses from March 15, 2025. Biotronik's digital health efforts center on remote patient monitoring via its Home Monitoring system, which automatically transmits daily cardiac data from implanted devices to clinicians, enabling early detection of arrhythmias or device issues without patient intervention, as implemented in systems like the CardioMessenger Smart. This integrates with electronic health records through tools like EHR DataSync, facilitating seamless data flow into clinic workflows and reducing manual follow-ups, a capability enhanced since its introduction around but continually updated for modern interoperability. The BIOTRONIK Patient App complements this by allowing patients to track symptoms and device status alongside Home Monitoring, though it operates independently of third-party health apps to maintain data security. Further integrations include CardioSphere, a platform providing alert-based insights for proactive management and remote care, processing device data to predict events. Biotronik partnered with on September 8, 2022, to incorporate AI-driven analytics into cardiac diagnostics and monitoring, enhancing connected care delivery. A more recent collaboration with the , announced October 22, 2025, focuses on developing AI-integrated digital tools that embed into clinical workflows for improved cardiac care efficiency and patient outcomes. These initiatives prioritize empirical monitoring data over subjective reporting, aligning with evidence showing reduced hospitalizations through proactive interventions.

Innovations and Achievements

Technological Breakthroughs

Biotronik pioneered the first implantable pacemaker in in 1963, marking an early milestone in cardiac rhythm management by enabling reliable long-term pacing for patients. In 1995, the company introduced Closed Loop Stimulation (CLS), a sensor-based algorithm in pacemakers that dynamically adjusts pacing rates in response to signals, such as mental stress, to mimic physiological more accurately than fixed-rate systems. This technology improved patient outcomes by reducing symptoms of chronotropic incompetence, as demonstrated in clinical evaluations showing enhanced quality-of-life metrics compared to conventional rate-responsive pacing. The company's Home Monitoring system, launched in the early 2000s, represented a significant advancement in remote patient monitoring, utilizing wireless, automatic daily transmissions via cellular networks to provide physicians with real-time data on device function and cardiac events without requiring patient-initiated actions. Voted a top innovation at the 2010 Cardiostim conference, it reduced clinical visits by up to 37% in studies while enabling early detection of arrhythmias, with over 3 million patient-years of data supporting its efficacy in preventing hospitalizations. Building on this, DX Technology, introduced for implantable cardioverter-defibrillators (ICDs), allows single-lead ventricular devices to achieve true atrial sensing via a floating atrial electrode, improving atrial fibrillation detection accuracy to over 96% and eliminating the need for additional leads in many patients. In vascular interventions, Biotronik's Orsiro , approved by the FDA in 2019, features an ultrathin 60-micrometer strut thickness with a , outperforming thicker-strut competitors like Xience in failure rates at one year (6.5% vs. 9.9%) in the BIOFLOW-V involving 1,334 patients. More recently, in March 2024, the Freesolve below-the-knee resorbable magnesium received FDA Device Designation for treating critical limb ischemia, offering temporary radial support that fully degrades within 12 months to restore vessel compliance and reduce long-term restenosis risks associated with permanent metal implants. Advancements in monitoring continued with the BIOMONITOR IV insertable cardiac monitor, CE-marked in 2024, which integrates SmartECG signal processing and AI algorithms to achieve an 86% reduction in false-positive detections for arrhythmias, enhancing diagnostic precision in subcutaneous ECG recordings. In pacing innovation, the 2025 first-in-human implant of the Acticor/Rivacor Sky CRT-D device optimized for left bundle branch area pacing (LBBAP) demonstrated feasibility for conduction system pacing, potentially improving resynchronization therapy efficacy over traditional biventricular methods by preserving native conduction pathways. These developments underscore Biotronik's focus on minimizing invasiveness and integrating digital diagnostics, supported by over 3,000 patents in active implants.

Awards and Industry Recognitions

In 2025, BIOTRONIK was named “Supplier of the Year” in the category by Prospitalia for the third consecutive year, recognizing its excellence and reliability in delivering medical technologies. BIOTRONIK's BioMonitor IIIm implantable cardiac monitor received the Frost & Sullivan Enabling Technology Leadership Award in 2021, honoring its innovative flexible antenna design that enables high-definition ECG signals, adaptive algorithms for accurate detection, and overall disruption in cardiac monitoring performance. The company's Home Monitoring system earned recognition from for achieving a 98% transmission compliance rate, the highest among competitors, which supports early detection of device and patient issues through reliable remote data transfer. At the Cardiostim conference, delegates voted BIOTRONIK Home Monitoring as the top innovation, highlighting its advancements in for cardiac rhythm management devices. In 2019, the PK Papyrus covered system was selected as a finalist for the Prix Galien Award in the Device category, acknowledging its efficacy in treating coronary perforations and acute vessel closures during percutaneous interventions.

Partnerships and Collaborations

Strategic Alliances and Research Partnerships

Biotronik has pursued strategic alliances with academic institutions to advance research in cardiovascular and . In October 2025, the company entered a three-year with the to develop and clinically evaluate digital tools for , , and personalized cardiac care, aiming to integrate AI and connected health solutions into clinical practice. Similarly, in February 2024, Biotronik expanded its strategic cooperation with TU Dresden's Institute of , focusing on joint research projects, student training, and in areas such as implantable devices and bioelectronics, building on prior collaborations since at least 2010. In commercial research-oriented partnerships, Biotronik collaborated with starting in September 2022 to integrate AI-enabled ECG analysis with Biotronik's remote monitoring systems, enabling faster detection and treatment decisions through combined wearable and implantable data streams; this marked the first in a planned series of disruptions. The alliance with Egg Medical, announced on February 19, 2025, combines Biotronik's expertise with Egg's radiation shielding technology to conduct joint studies on reducing occupational exposure during procedures, with initial distribution in select markets to support evidence generation. Additional alliances emphasize technology co-development and distribution with research components. For instance, the July 2025 distribution agreement with CardioFocus facilitates European access to pulsed field systems, including shared clinical data for refining energy delivery protocols in treatment. Biotronik's June 2023 strategic alliance with targets out-of-hospital cardiology by integrating imaging and monitoring platforms, with ongoing evaluations to optimize workflow efficiency in non-acute settings. These partnerships underscore Biotronik's emphasis on evidence-based innovation, often involving multi-year commitments to clinical validation and regulatory alignment.

Recent Collaborations and Acquisitions

In February 2025, BIOTRONIK announced the divestiture of substantially all of its Vascular Intervention business to Teleflex Incorporated for approximately €760 million in cash. The transaction, which included coronary and peripheral intervention products such as drug-coated balloon catheters and stents, was completed on July 1, 2025, enabling BIOTRONIK to refocus resources on its core implantable cardiac devices and electrophysiology portfolio. This strategic shift was positioned by BIOTRONIK as a means to streamline operations amid competitive pressures in the vascular market. On July 24, 2025, BIOTRONIK entered a distribution partnership with CardioFocus, designating BIOTRONIK as the exclusive distributor of the Centauri Pulsed Field system in selected European countries. The agreement aims to broaden access to non-thermal technology for treatment, combining CardioFocus's device innovation with BIOTRONIK's established infrastructure. In October 2025, BIOTRONIK initiated a three-year research collaboration with the to develop digital health solutions for cardiac disease management, focusing on scalable remote monitoring and tools. The partnership leverages BIOTRONIK's device data integration capabilities alongside the university's expertise in AI-driven to enhance patient outcomes in chronic cardiac conditions.

Marketing and Compliance Investigations

In July 2022, the U.S. Department of Justice (DOJ) announced an investigation into Biotronik Inc. for alleged violations of the Anti-Kickback Statute (AKS), stemming from claims that the company provided improper remuneration to physicians to induce the use of its cardiac rhythm management devices in federal healthcare programs. Prosecutors alleged that Biotronik funded lavish holiday parties for physicians and their staff, disguised as educational events, and exploited a new employee training program by paying physicians for excessive, sham training sessions that did not comply with standards. Internal compliance warnings highlighted sales representatives' in selecting trainers, raising concerns over inducements tied to device implantation referrals. The investigation, initiated via whistleblower qui tam actions under the False Claims Act (FCA), accused Biotronik of causing the submission of false claims to Medicare and by linking payments to volume or value of referrals. Biotronik denied the allegations, stating the settlement—reached without admission of liability—reflected a desire to resolve historical matters efficiently while emphasizing its commitment to ethical practices. As part of the resolution, Biotronik entered a Corporate Integrity Agreement with the Department of Health and Human Services Office of Inspector General, mandating enhanced compliance monitoring, reporting, and independent reviews of physician engagements for five years. Separate FCA qui tam complaints, filed by former employees, alleged Biotronik engaged in off-label promotion of its devices, including marketing unapproved uses for left bundle branch area pacing and other indications beyond FDA clearances. These suits claimed violations of both the AKS and through sham consulting fees and referral inducements, with sales training purportedly encouraging off-label discussions to boost implantation rates. A U.S. District Court initially dismissed the cases in 2023 for lack of particularity, but on September 10, 2025, the Ninth Circuit Court of Appeals reversed, holding that the relators' allegations of specific kickback schemes and off-label tactics met FCA pleading standards, allowing the investigation to proceed. FDA inspections have occasionally flagged compliance issues, though primarily manufacturing-related rather than violations. A 2017 warning letter to Biotronik SE & Co. KG cited quality system deficiencies at its facility, including inadequate complaint handling and process controls, but did not address promotional practices. Earlier enforcement, such as a 2004 FDA letter on promotional labeling for implantable cardioverter defibrillators, underscored ongoing regulatory scrutiny but predates recent marketing probes. No public FDA actions specifically targeting off-label marketing have been documented, with investigations largely deferred to DOJ in physician payment contexts.

Settlements and Ongoing Litigation

In July 2022, Biotronik Inc. agreed to pay $12.95 million to the and several states to resolve allegations under the False Claims Act that the company violated the Anti-Kickback Statute by providing improper remuneration to physicians, including excessive payments for training sessions and sham consulting arrangements intended to induce the use of Biotronik's cardiac rhythm management devices such as pacemakers and defibrillators. The settlement stemmed from a whistleblower lawsuit and did not include an admission of liability by Biotronik. On February 5, 2025, Biotronik Inc. settled additional False Claims Act allegations by agreeing to pay $4.9 million to the for claims that the company paid kickbacks to physicians to reward and induce referrals for implantable cardioverter defibrillators and other devices reimbursable by federal healthcare programs. This resolution, also based on whistleblower disclosures, addressed conduct alleged to have occurred between 2012 and 2018 and similarly involved no admission of wrongdoing. As of September 2025, ongoing litigation includes a revived action under the False Claims Act, United States ex rel. Sam Jones Company LLC v. Biotronik Inc., where the Ninth Circuit Court of Appeals reversed a district court's dismissal on public disclosure grounds, allowing the whistleblower's claims to proceed. The suit alleges a nationwide kickback scheme from 2013 onward, involving Biotronik's payments to physicians for sham research, consulting, and royalty deals to promote device implantation, potentially violating the Anti-Kickback Statute and . The case, originally filed in 2017, contends these arrangements generated false Medicare claims and highlights Biotronik's alleged use of non-public details to distinguish from prior disclosures.

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