Press Releases and Statements

At the Digital Heart Summit 2025 in Berlin, 120 leading experts gathered to explore how digital innovation is reshaping cardiovascular care. Organized by BIOTRONIK, the event spotlighted the growing impact of artificial intelligence, real-world data, and patient-centric technologies in redefining diagnostics and treatment strategies. Discussions highlighted how digital tools are moving toward proactive, preventive care. For the experts, the vision is clear: by integrating AI-driven insights with patient engagement strategies, connected platforms can support informed decision-making across

This Three-Year Collaboration Aims to Deliver Scalable Health Solutions for Improved Disease Management The Initiative Hopes to Benefit Patients Particularly in Remote or Underserved Regions with Limited Access to Care SYDNEY, Australia – BIOTRONIK, a global leader in medical technology, and the University of Sydney, one of the world’s top research and teaching institutions, have signed a Memorandum of Understanding (MoU) to jointly advance digital and connected health innovations through 2028. By combining BIOTRONIK’s expertise in implanted cardiac devices and remote monitoring with the

BIOTRONIK, a global leader in medical technology, and a pioneer in cardiovascular, endovascular, and neuromodulation solutions, today announced a strategic shift to strengthen its leadership in active implantable devices and digital healthcare. Leveraging future technologies, including artificial intelligence (AI), remote patient monitoring and connected healthcare platforms, BIOTRONIK is at the forefront of improving patient outcomes and optimizing clinical workflows. These innovations are designed to enhance the efficiency and accessibility of care, enabling healthcare providers with next

BIOTRONIK is pleased to announce the limited release of its Oscar ® ( One Solution: Cross. Adjust. Restore) multifunctional peripheral catheter and start of promotional activities at LINC, the Leipzig Interventional Course held June 6-9 in Leipzig, Germany. As indicated per Instructions for Use, the Oscar catheter is intended for dilation of stenotic segments in peripheral vessels. The device is comprised of three fully user-adjustable components (support catheter with integrated Lock Grip, extendable dilator and length-adjustable PTA balloon). It was developed to provide support during access

In the first-in-human study BIOMAG-I, BIOTRONIK’s new-generation DREAMS 3G resorbable magnesium scaffold (RMS) showed significantly lower in-scaffold late lumen loss (LLL) than its predecessor at 12 months as well as excellent safety and efficacy. Prof. Michael Haude, BIOMAG-I Coordinating Clinical Investigator, presented the latest results in the late breaking trial session at the EuroPCR course. 1 At one-year follow-up, BIOMAG-I data confirmed the excellent safety profile of DREAMS 3G RMS with a low target lesion failure rate of 2.6%. Neither cardiac death and myocardial infarction occurred

BIOTRONIK, a leading global medical technology company with 60 years of experience in developing trusted cardiovascular and endovascular solutions, announced today the latest addition to its cardiac rhythm management portfolio. "We are excited to have received CE mark for our newest technology – the world’s first pacemakers and CRT-Ps approved for left bundle branch pacing. Amvia Sky and Amvia Edge represent cutting-edge innovation and incorporate the latest cardiology trends," says Dr. Andreas Hecker, President CRM/EP at BIOTRONIK. In 1963, BIOTRONIK introduced the first German implantable

The company today announced U.S. Food and Drug Administration (FDA) approval for Prospera™, a spinal cord stimulation (SCS) system. The system features RESONANCE™, the first and only multiphase stimulation paradigm, paired with Embrace One™, a patient-centric care model that makes proactive care possible by offering automatic, objective, daily remote monitoring and ongoing management and support. 1 This approval marks the launch of the company’s new business segment, BIOTRONIK Neuro. Millions of people all over the world suffer from chronic intractable pain, a severe, constant, and

Results from the MATRIX study show that the high detection accuracy of DX single-lead ICD systems for atrial fibrillation (AF) episodes (99.7% for ≥ 1h episodes) in combination with the strong transmission performance of BIOTRONIK Home Monitoring ® allows for reliable guideline-recommended remote monitoring of subclinical AF. The findings were published in Europace earlier this week. 1 MATRIX evaluated the utility of the DX-ICD system (atrial signal detection via a floating dipole integrated in the ICD lead) for remotely monitoring atrial high-rate episodes (AHRE) and their duration

On October 1, the US Food and Drug Administration (FDA) issued a Safety Communication regarding a set of cybersecurity vulnerabilities, referred to as “Urgent/11” that — if exploited by a remote attacker — may introduce risks for medical devices and hospital networks. According to the communication: “These vulnerabilities may allow anyone to remotely take control of the medical device and change its function, cause denial of service, or cause information leaks or logical flaws, which may prevent device function.” These vulnerabilities exist in a third-party software component known as IPnet

The work ‘Security Testing of the Pacemaker Ecosystem’ was recently published as a master’s thesis, authored by Mr. Anders Been Wilhelmsen and Mr. Eivind Skjelmo Kristiansen. This publication investigates the state of cybersecurity of BIOTRONIK’s ICS 3000 – a programmer for BIOTRONIK implantable cardiac pacemakers, defibrillators and monitors that is used by healthcare professionals during the implantation procedure and follow-ups. ICS 3000 programmers were distributed between 2001 and 2012. In the publication, the authors report about several cybersecurity weaknesses such as: The central

As the COVID-19 pandemic continues, we are conscious of the enormous strain that you are all under. We share your concerns about the spread of the virus and the disruption it is causing globally. We are doing what we can to help minimize this disruption and to provide support so that you can focus on the critical task of saving lives. To this end, we would like to inform you of the following:

The US Food and Drug Administration has issued a Safety Communication regarding a family of cybersecurity vulnerabilities known as SweynTooth, which may introduce risks for certain medical devices that use Bluetooth Low Energy (BLE) wireless communication technology. If exploited, these vulnerabilities can allow unauthorized users to potentially cause a device to stop working, stop it from working correctly and/or bypass security to access certain device functions. The FDA has said it is not aware of any confirmed adverse events related to these vulnerabilities although software to exploit