The FDA late last week released draft guidance outlining recommendations for medical devices containing nitinol, an alloy of nickel and titanium, in a push to more fully evaluate materials used in medical devices.
The newly published draft guidance, titled “Technical considerations for non-clinical assessment of medical devices containing nitinol,” includes proposed recommendations on what manufacturers should include in their premarket submission for devices containing the metal.
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.