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The FDA approved a firmware update that is now available and is intended as a recall, specifically a corrective action, to reduce the risk of patient harm due to potential exploitation of cybersecurity vulnerabilities for certain Abbott (formerly St. Jude Medical) pacemakers. “Firmware” is a specific type of software embedded in the hardware of a medical device (e.g. a component in the pacemaker).

For the purposes of this safety communication, cybersecurity focuses on protecting patients’ medical devices and their associated computers, networks, programs, and data from unintended or unauthorized access, change, or destruction.

The FDA recommends that patients and their health care providers discuss the risks and benefits of the cybersecurity vulnerabilities and the associated firmware update designed to address such vulnerabilities at their next regularly scheduled visit.

The FDA has reviewed information concerning potential cybersecurity vulnerabilities associated with St. Jude Medical’s RF-enabled implantable cardiac pacemakers and has confirmed that these vulnerabilities, if exploited, could allow an unauthorized user (i.e. someone other than the patient’s physician) to access a patient’s device using commercially available equipment.

For more information on this recall, please visit the FDA’s official Safety Communication Pages

For Further InformationThe full report covers market segments for pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy devices, cardiac lead, external defibrillators, cardiac ablation, diagnostic electrophysiology devices, and electro-cardiograph and cardiac monitoring devices. The iData series on the market for cardiac rhythm devices covers the U.S., and 15 countries in Europe. Full reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment.