FDA also supports the removal of the HeartWare HVAD System from the market.
GI Genius is based on machine learning and helps clinicians detect lesions in real time during a colonoscopy.
Reported issues related to the device include two injuries and one death.
The Harmony Transcatheter Pulmonary Valve is an alternative to open heart surgery.
There have been 29 complaints, including 19 serious injuries and two deaths, related to the device issue.
Seamless and personalized diabetes care has become a new normal.
A product issue could lead to serious health consequences, including loss of consciousness, bleeding, fluid buildup around the heart and death.
AdvaMed has reported that its member companies have provided $26.8 million in medical supplies, along with $4.1 million in cash donations.
Executive Vice President Geoff Martha will succeed Ishrak.
The agency is recommending that patients replace their affected pumps with models that can better protect against the risks.