WASHINGTON – U.S. regulators on Wednesday ordered makers of 25 types of medical devices to supply safety and effectiveness data so the government can decide whether the products must undergo the ...

Medical device cybersecurity remains a chief concern for health IT executives who say manufacturers are largely to blame for vulnerabilities, particularly with older legacy devices. Nearly one ...

There are a broad range of medical devices that may be vulnerable to cybersecurity breaches, said Rep. Gary Palmer (R-Ala.), chairman of the House Energy & Commerce Oversight and Investigations ...

In his June 2, 2019 episode, he covered the dangers of using older medical devices to get FDA clearance, which I'll explain below. ... See all photos. The system isn't perfect.

Documentary "The Bleeding Edge" shines light on medical device risks 04:51. WASHINGTON – U.S. health officials said Monday they plan to overhaul the nation's decades-old system for approving ...

The report proposes multiple actions to protect older medical devices, including research into more modular devices and collecting data on cyber risks. The MITRE report forms part of the FDA’s ...

The number of connected medical devices being used in hospitals and healthcare organizations continues to grow at a rapid pace, representing a vulnerable surface for cyberattacks. Raising the ...

In a matched analysis, medical devices approved based on a predicate device that was subject to a class 1 recall were more than six times more likely to also undergo a class 1 recall when compared ...