Press Releases and Statements Read our latest company news and announcements Image Press Releases Filter and Search Filter by year - Qualquer -20242023202220212020 Search 48 press releases Image 24 Fevereiro 2023 BERLIN, Germany Press Release BIOTRONIK Conduction System Pacing Tools Received CE Mark for Left Bundle Branch Area Pacing BIOTRONIK announced today that it has received CE approval for the Selectra 3D implant tools to include left bundle branch area pacing (LBBAP) in addition to His-bundle pacing (HBP). Commonly referred to as conduction system pacing (CSP) these two approaches have emerged as a physiologic pacing alternative to avoid dyssynchronous contraction of the heart which can induce various negative long-term effects for patients. 1-3 Approved in 2021 for HBP, Selectra 3D’s safety and effectiveness for CSP has been shown in over 10 studies with more than 1,000 patients. In the multi-center Belgium Image 14 Fevereiro 2023 BUELACH, Switzerland Press Release BIOTRONIK Announces Its Latest Innovation: Oscar Multifunctional Peripheral Catheter BIOTRONIK announces the FDA 510(k) clearance and CE mark of its Oscar ® ( One Solution: Cross. Adjust. Restore) multifunctional peripheral catheter. Physicians in the U.S. have already used the novel device in more than 70 cases. As indicated per Instructions for Use, Oscar is intended for percutaneous transluminal interventions in the peripheral vasculature. The device was developed to provide support during access into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries. The Oscar peripheral multifunctional catheter is comprised of three user-adjustable components: The Image 15 Dezembro 2021 Statement BIOTRONIK Statement on the Log4Shell Vulnerability The discovery of a high-severity vulnerability known as Log4Shell was disclosed publicly on December 9, 2021, while a related lower-severity vulnerability was disclosed on December 14, 2021. These vulnerabilities are present in a software library used by many servers worldwide (see Background for details). In light of this recent discovery, BIOTRONIK has carefully analyzed all of its provided services. The analysis concluded that the conditions for exploitation of the Log4Shell vulnerability and the related CVE-2021-45046 and CVE-2021-45105 vulnerabilities do not exist in any of BIOTRONIK’s Image 28 Janeiro 2021 BERLIN, Germany Statement Statement on Apple iPhone 12 and BIOTRONIK Devices The most recent series of Apple iPhones include a stronger magnetic array than previous models. A recent study 1 published in the HeartRhythm Journal reported that therapy was suspended when an iPhone 12 was brought into close contact with specific implanted cardioverter defibrillator (ICD) devices. After further investigation, BIOTRONIK has concluded that there is no additional risk and our advice concerning potential interference from this and former iPhone models remains unchanged. We continue to advise patients implanted with BIOTRONIK cardiac devices to maintain the recommended distance Image 19 Junho 2020 Statement BIOTRONIK Statement on CardioMessenger II Cybersecurity CardioMessenger devices form an essential part of BIOTRONIK’s remote monitoring system, enabling the secure transmission of critical patient and device data to the treating physician. As the company that pioneered remote monitoring, we have taken cybersecurity design seriously since 2001. It is integrated into our quality management system, all relevant business processes and prioritized at every step of the product life cycle. Our cardiac implants do not accept programming modifications or commands via any form of long-distance communication. By design, it is technically impossible to Image 31 Março 2020 Statement A Message to Our Valued Customers and Their Patients 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: Image 4 Março 2020 Statement BIOTRONIK Statement on “SweynTooth” Cybersecurity Vulnerabilities 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 Image 4 Outubro 2019 BIOTRONIK Statement on the FDA’s Safety Communication “URGENT/11” 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 Image 12 Agosto 2019 Statement BIOTRONIK Statement on the Publication ‘Security Testing of the Pacemaker Ecosystem’ 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 Image 22 Março 2019 Statement BIOTRONIK Statement on the Medical Advisory and Safety Communication Regarding Medtronic’s Conexus Radio Frequency Telemetry Protocol The Department of Homeland Security and the US FDA have issued a Medical Advisory and Safety Communication respectively describing two types of cybersecurity vulnerabilities affecting multiple Medtronic devices that utilize the Conexus telemetry protocol. BIOTRONIK utilizes substantially different protocols for both the clinical and the home environment. Moreover, by design, the remote communication system via BIOTRONIK Home Monitoring® does not have the functionality to transmit or alter therapeutic commands to the implant. Image 18 Outubro 2018 Statement BIOTRONIK Statement on the Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers On October 11, the US Food and Drug Administration (FDA) issued a Safety Communication regarding cybersecurity updates affecting Medtronic implantable cardiac device programmers, based on an NCCIC Advisory. 1 According to the FDA’s communication, Medtronic is issuing a software update to address a safety risk caused by cybersecurity vulnerabilities associated with the internet connection in two models of programmers used to download software from the manufacturer’s software distribution network (SDN). Successful exploitation of these vulnerabilities would allow an adversary to influence this Image 17 Agosto 2018 Statement Statement on the Cybersecurity of BIOTRONIK Solutions Following WIRED Magazine’s Article on Vulnerabilities in Pacemaker Programmer Systems On August 9, WIRED magazine reported that researchers discovered cybersecurity vulnerabilities in the way pacemaker programmers connected to the software delivery network of a specified manufacturer. The researchers claim that “digital code signing”—the cryptographic validation of the legitimacy and integrity of software—is lacking in the manufacturer’s infrastructure, allowing an attacker to potentially take control of device programmers through malicious updates that can subsequently be spread to implanted pacemakers. 1 None of BIOTRONIK’s devices, programmers or networks are affected by Paginação Page 1 Page 2 Page 3 Página atual 4 Página anterior ‹ Previous Subscribe to Our News You must have JavaScript enabled to use this form. Your Name Your Email Subject Message *Fields are mandatory. Latest Blog Posts Show all blog articles Image 25 Outubro 2024 Blog BIOTRONIK’s Longstanding Cooperation with Die ARCHE: A Partnership for Children Image 29 Setembro 2024 Heart Monitoring for Irregular Heartbeat: “I Can Now Do Sports Again Without Any Worries.” A BIOTRONIK employee shares his experience as a patient with an implantable cardiac monitor. Image 16 Setembro 2024 Blog Shaping Health Behaviors in Patients with Coronary Heart Disease Optimizing Patient Experience With eHealth Solutions Press Contact Corporate Public Relations & Communications press@biotronik.com +49 (0) 30 68905 1414 Get in contact
Image 24 Fevereiro 2023 BERLIN, Germany Press Release BIOTRONIK Conduction System Pacing Tools Received CE Mark for Left Bundle Branch Area Pacing BIOTRONIK announced today that it has received CE approval for the Selectra 3D implant tools to include left bundle branch area pacing (LBBAP) in addition to His-bundle pacing (HBP). Commonly referred to as conduction system pacing (CSP) these two approaches have emerged as a physiologic pacing alternative to avoid dyssynchronous contraction of the heart which can induce various negative long-term effects for patients. 1-3 Approved in 2021 for HBP, Selectra 3D’s safety and effectiveness for CSP has been shown in over 10 studies with more than 1,000 patients. In the multi-center Belgium
Image 24 Fevereiro 2023 BERLIN, Germany Press Release BIOTRONIK Conduction System Pacing Tools Received CE Mark for Left Bundle Branch Area Pacing BIOTRONIK announced today that it has received CE approval for the Selectra 3D implant tools to include left bundle branch area pacing (LBBAP) in addition to His-bundle pacing (HBP). Commonly referred to as conduction system pacing (CSP) these two approaches have emerged as a physiologic pacing alternative to avoid dyssynchronous contraction of the heart which can induce various negative long-term effects for patients. 1-3 Approved in 2021 for HBP, Selectra 3D’s safety and effectiveness for CSP has been shown in over 10 studies with more than 1,000 patients. In the multi-center Belgium
Image 14 Fevereiro 2023 BUELACH, Switzerland Press Release BIOTRONIK Announces Its Latest Innovation: Oscar Multifunctional Peripheral Catheter BIOTRONIK announces the FDA 510(k) clearance and CE mark of its Oscar ® ( One Solution: Cross. Adjust. Restore) multifunctional peripheral catheter. Physicians in the U.S. have already used the novel device in more than 70 cases. As indicated per Instructions for Use, Oscar is intended for percutaneous transluminal interventions in the peripheral vasculature. The device was developed to provide support during access into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries. The Oscar peripheral multifunctional catheter is comprised of three user-adjustable components: The
Image 14 Fevereiro 2023 BUELACH, Switzerland Press Release BIOTRONIK Announces Its Latest Innovation: Oscar Multifunctional Peripheral Catheter BIOTRONIK announces the FDA 510(k) clearance and CE mark of its Oscar ® ( One Solution: Cross. Adjust. Restore) multifunctional peripheral catheter. Physicians in the U.S. have already used the novel device in more than 70 cases. As indicated per Instructions for Use, Oscar is intended for percutaneous transluminal interventions in the peripheral vasculature. The device was developed to provide support during access into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries. The Oscar peripheral multifunctional catheter is comprised of three user-adjustable components: The
Image 15 Dezembro 2021 Statement BIOTRONIK Statement on the Log4Shell Vulnerability The discovery of a high-severity vulnerability known as Log4Shell was disclosed publicly on December 9, 2021, while a related lower-severity vulnerability was disclosed on December 14, 2021. These vulnerabilities are present in a software library used by many servers worldwide (see Background for details). In light of this recent discovery, BIOTRONIK has carefully analyzed all of its provided services. The analysis concluded that the conditions for exploitation of the Log4Shell vulnerability and the related CVE-2021-45046 and CVE-2021-45105 vulnerabilities do not exist in any of BIOTRONIK’s
Image 15 Dezembro 2021 Statement BIOTRONIK Statement on the Log4Shell Vulnerability The discovery of a high-severity vulnerability known as Log4Shell was disclosed publicly on December 9, 2021, while a related lower-severity vulnerability was disclosed on December 14, 2021. These vulnerabilities are present in a software library used by many servers worldwide (see Background for details). In light of this recent discovery, BIOTRONIK has carefully analyzed all of its provided services. The analysis concluded that the conditions for exploitation of the Log4Shell vulnerability and the related CVE-2021-45046 and CVE-2021-45105 vulnerabilities do not exist in any of BIOTRONIK’s
Image 28 Janeiro 2021 BERLIN, Germany Statement Statement on Apple iPhone 12 and BIOTRONIK Devices The most recent series of Apple iPhones include a stronger magnetic array than previous models. A recent study 1 published in the HeartRhythm Journal reported that therapy was suspended when an iPhone 12 was brought into close contact with specific implanted cardioverter defibrillator (ICD) devices. After further investigation, BIOTRONIK has concluded that there is no additional risk and our advice concerning potential interference from this and former iPhone models remains unchanged. We continue to advise patients implanted with BIOTRONIK cardiac devices to maintain the recommended distance
Image 28 Janeiro 2021 BERLIN, Germany Statement Statement on Apple iPhone 12 and BIOTRONIK Devices The most recent series of Apple iPhones include a stronger magnetic array than previous models. A recent study 1 published in the HeartRhythm Journal reported that therapy was suspended when an iPhone 12 was brought into close contact with specific implanted cardioverter defibrillator (ICD) devices. After further investigation, BIOTRONIK has concluded that there is no additional risk and our advice concerning potential interference from this and former iPhone models remains unchanged. We continue to advise patients implanted with BIOTRONIK cardiac devices to maintain the recommended distance
Image 19 Junho 2020 Statement BIOTRONIK Statement on CardioMessenger II Cybersecurity CardioMessenger devices form an essential part of BIOTRONIK’s remote monitoring system, enabling the secure transmission of critical patient and device data to the treating physician. As the company that pioneered remote monitoring, we have taken cybersecurity design seriously since 2001. It is integrated into our quality management system, all relevant business processes and prioritized at every step of the product life cycle. Our cardiac implants do not accept programming modifications or commands via any form of long-distance communication. By design, it is technically impossible to
Image 19 Junho 2020 Statement BIOTRONIK Statement on CardioMessenger II Cybersecurity CardioMessenger devices form an essential part of BIOTRONIK’s remote monitoring system, enabling the secure transmission of critical patient and device data to the treating physician. As the company that pioneered remote monitoring, we have taken cybersecurity design seriously since 2001. It is integrated into our quality management system, all relevant business processes and prioritized at every step of the product life cycle. Our cardiac implants do not accept programming modifications or commands via any form of long-distance communication. By design, it is technically impossible to
Image 31 Março 2020 Statement A Message to Our Valued Customers and Their Patients 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:
Image 31 Março 2020 Statement A Message to Our Valued Customers and Their Patients 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:
Image 4 Março 2020 Statement BIOTRONIK Statement on “SweynTooth” Cybersecurity Vulnerabilities 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
Image 4 Março 2020 Statement BIOTRONIK Statement on “SweynTooth” Cybersecurity Vulnerabilities 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
Image 4 Outubro 2019 BIOTRONIK Statement on the FDA’s Safety Communication “URGENT/11” 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
Image 4 Outubro 2019 BIOTRONIK Statement on the FDA’s Safety Communication “URGENT/11” 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
Image 12 Agosto 2019 Statement BIOTRONIK Statement on the Publication ‘Security Testing of the Pacemaker Ecosystem’ 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
Image 12 Agosto 2019 Statement BIOTRONIK Statement on the Publication ‘Security Testing of the Pacemaker Ecosystem’ 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
Image 22 Março 2019 Statement BIOTRONIK Statement on the Medical Advisory and Safety Communication Regarding Medtronic’s Conexus Radio Frequency Telemetry Protocol The Department of Homeland Security and the US FDA have issued a Medical Advisory and Safety Communication respectively describing two types of cybersecurity vulnerabilities affecting multiple Medtronic devices that utilize the Conexus telemetry protocol. BIOTRONIK utilizes substantially different protocols for both the clinical and the home environment. Moreover, by design, the remote communication system via BIOTRONIK Home Monitoring® does not have the functionality to transmit or alter therapeutic commands to the implant.
Image 22 Março 2019 Statement BIOTRONIK Statement on the Medical Advisory and Safety Communication Regarding Medtronic’s Conexus Radio Frequency Telemetry Protocol The Department of Homeland Security and the US FDA have issued a Medical Advisory and Safety Communication respectively describing two types of cybersecurity vulnerabilities affecting multiple Medtronic devices that utilize the Conexus telemetry protocol. BIOTRONIK utilizes substantially different protocols for both the clinical and the home environment. Moreover, by design, the remote communication system via BIOTRONIK Home Monitoring® does not have the functionality to transmit or alter therapeutic commands to the implant.
Image 18 Outubro 2018 Statement BIOTRONIK Statement on the Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers On October 11, the US Food and Drug Administration (FDA) issued a Safety Communication regarding cybersecurity updates affecting Medtronic implantable cardiac device programmers, based on an NCCIC Advisory. 1 According to the FDA’s communication, Medtronic is issuing a software update to address a safety risk caused by cybersecurity vulnerabilities associated with the internet connection in two models of programmers used to download software from the manufacturer’s software distribution network (SDN). Successful exploitation of these vulnerabilities would allow an adversary to influence this
Image 18 Outubro 2018 Statement BIOTRONIK Statement on the Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers On October 11, the US Food and Drug Administration (FDA) issued a Safety Communication regarding cybersecurity updates affecting Medtronic implantable cardiac device programmers, based on an NCCIC Advisory. 1 According to the FDA’s communication, Medtronic is issuing a software update to address a safety risk caused by cybersecurity vulnerabilities associated with the internet connection in two models of programmers used to download software from the manufacturer’s software distribution network (SDN). Successful exploitation of these vulnerabilities would allow an adversary to influence this
Image 17 Agosto 2018 Statement Statement on the Cybersecurity of BIOTRONIK Solutions Following WIRED Magazine’s Article on Vulnerabilities in Pacemaker Programmer Systems On August 9, WIRED magazine reported that researchers discovered cybersecurity vulnerabilities in the way pacemaker programmers connected to the software delivery network of a specified manufacturer. The researchers claim that “digital code signing”—the cryptographic validation of the legitimacy and integrity of software—is lacking in the manufacturer’s infrastructure, allowing an attacker to potentially take control of device programmers through malicious updates that can subsequently be spread to implanted pacemakers. 1 None of BIOTRONIK’s devices, programmers or networks are affected by
Image 17 Agosto 2018 Statement Statement on the Cybersecurity of BIOTRONIK Solutions Following WIRED Magazine’s Article on Vulnerabilities in Pacemaker Programmer Systems On August 9, WIRED magazine reported that researchers discovered cybersecurity vulnerabilities in the way pacemaker programmers connected to the software delivery network of a specified manufacturer. The researchers claim that “digital code signing”—the cryptographic validation of the legitimacy and integrity of software—is lacking in the manufacturer’s infrastructure, allowing an attacker to potentially take control of device programmers through malicious updates that can subsequently be spread to implanted pacemakers. 1 None of BIOTRONIK’s devices, programmers or networks are affected by
Image 25 Outubro 2024 Blog BIOTRONIK’s Longstanding Cooperation with Die ARCHE: A Partnership for Children
Image 25 Outubro 2024 Blog BIOTRONIK’s Longstanding Cooperation with Die ARCHE: A Partnership for Children
Image 29 Setembro 2024 Heart Monitoring for Irregular Heartbeat: “I Can Now Do Sports Again Without Any Worries.” A BIOTRONIK employee shares his experience as a patient with an implantable cardiac monitor.
Image 29 Setembro 2024 Heart Monitoring for Irregular Heartbeat: “I Can Now Do Sports Again Without Any Worries.” A BIOTRONIK employee shares his experience as a patient with an implantable cardiac monitor.
Image 16 Setembro 2024 Blog Shaping Health Behaviors in Patients with Coronary Heart Disease Optimizing Patient Experience With eHealth Solutions
Image 16 Setembro 2024 Blog Shaping Health Behaviors in Patients with Coronary Heart Disease Optimizing Patient Experience With eHealth Solutions