FDA Reports Hacking Risk In St. Jude Medical Heart Devices

Law360, New York (January 10, 2017, 7:24 PM EST) -- Medical device maker St. Jude Medical Inc.'s smart pacemakers and defibrillators may be vulnerable to cybersecurity hacking, the U.S. Food and Drug Administration said on Monday, giving weight to late summer reports of the issues, which St. Jude vehemently contested at the time.

Implantable cardiac devices, including pacemakers, defibrillators and resynchronization devices that use St. Jude's Merlin@home transceiver to communicate radio frequency signals that export device data “can be vulnerable to cybersecurity intrusions and exploits,” the FDA said in a safety alert.

The issues “could allow...
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