FDA to step-up cybersecurity scrutiny in med device clearances

The FDA is taking steps to increase its scrutiny of efforts taken by medical device developers to limit cybersecurity vulnerabilities in their connected products, but may need to take extra steps, according to a newly released report from the US Dept. of Health and Human Services’ Office of Inspector General.

The report analyzed the FDA’s efforts to evaluate how secure devices are prior to approval, and found that the agency is taking a number of steps to do so, but could improve upon its current strategy.

Get the full story on our sister site MassDevice. 

Theranos whistleblower Tyler Shultz to participate in keynote interview at DeviceTalks Boston At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos. Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston. REGISTER NOW