Coming soon: A plain-language document for medical device data systems developers such as hospitals and small IT vendors that have little experience with FDA regulation.
An AAMI document due for publication in mid-April will offer plain-language help for hospitals and IT vendors affected by FDA's 2011 regulation on medical device data systems.
Under FDA's Feb. 14, 2011, medical device data systems (MDDS) rule, those designing software systems that passively store data collected...
Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.
The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.
