GI Genius is based on machine learning and helps clinicians detect lesions in real time during a colonoscopy.
The Harmony Transcatheter Pulmonary Valve is an alternative to open heart surgery.
Software continues to be a key factor in recalls, and this year the end of some EUAs may also contribute to an increase.
The test generates results within 20 minutes and can be used by adults and children over the age of two years old.
The record-high number of authorizations last year was a significant jump over 2019.
The agency created the new post within CDRH, effective January 1.
The greatest challenge faced is an understanding of the intent of the written regulations and applying them correctly.
Woodcock was selected by outgoing Commissioner Stephen Hahn, M.D.
During this week’s Consumer Electronics Show, FDA Principal Deputy Commissioner Amy Abernathy talks about lessons learned from the pandemic and 2021 goals.
The exemption reduces the regulatory burden on the medical device industry—including the time and costs involved in preparing, submitting and responding to requests for additional information.