Dive Brief:
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Medtronic has received FDA approval for a product to program and manage data from its implanted cardiac devices.
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The product, CareLink SmartSync Device Manager, allows healthcare professionals to wirelessly connect to cardiac devices via an Apple iPad.
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Medtronic has made the device available at select sites in the U.S. ahead of the start of a planned full launch in the country in August.
Dive Insight:
Medtronic sells CareLink 2090 to make it easier to program pacemakers and manage the data they generate. The company says CareLink SmartSync, a next-generation take on 2090, uses a simplified version of the interface on its predecessor to ease the transition to the new product and make it more user-friendly.
Medtronic highlighted security improvements since CareLink 2090, including its prioritization of high-level security design capabilities when developing the device, and adoption of multi-encryption, intrusion detection monitoring and restrictions to protect the device and data transmissions.
The company's focus on cybersecurity follows a dispute over the discovery of vulnerabilities in Medtronic’s older pacemaker programmer, CareLink 2090. In February 2018, Medtronic said third-party security experts identified vulnerabilities but its own assessment found the risks were known, controlled and acceptable. The same experts later showed they could remotely control pacemakers and alter the schedule of shocks they deliver.
Later in 2018, FDA issued a cybersecurity safety communication about CareLink 2090 and Medtronic disabled internet updates for 34,000 devices. CareLink 2090 was also one of the devices affected by a critical cybersecurity vulnerability the Department of Homeland Security disclosed in March.
Those problems and broader concerns about hacking have made cybersecurity a focus of CareLink SmartSync but Medtronic is also trying to promote the device based on its other features. Medtronic received a CE mark for the device last year and said it has received positive reports from early users in Europe.
