Medical Device and Diagnostic Industry (MD+DI)

FDA Removes Medical Device Application Review Barrier

FDA is removing barriers to real-world evidence in device applications, allowing the use of de-identified patient data from ...

The FDA rarely forces manufacturers to recall dangerous medical devices, watchdog report finds

The Food and Drug Administration rarely uses its authority to pull dangerous medical devices off the market and is so poorly ...
WGRZ

Doctor convicted of re-using medical devices in surgeries, frauding Medicare millions has appeal denied

CHARLOTTE, N.C. — A federal appeals court has upheld the conviction of a North Carolina ear, nose and throat doctor who reused single-use surgical devices on over 1,400 Medicare patients and defrauded ...
Crain's Chicago Business

Durbin, Schakowsky take aim at medical device recalls

The Illinois lawmakers want an electronic format for medical device makers to quickly and transparently report recall ...

Doctor accused of fraud and reusing single-use medical devices took stand in own defense

Dr. Sanjeev Kumar, the Memphis gynecologist accused of fraud and re-using single-use medical devices, took the stand in his ...
Medical Device and Diagnostic Industry (MD+DI)

Two Key Medical Device Leaders Ditch FDA

FDA loses two key leaders as Jessica Paulsen departs Digital Health Center and David McMullen joins Neuralink amid staffing ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
WFMY News2

NC doctor convicted of re-using medical devices in surgeries, defrauding Medicare millions has appeal denied

CHARLOTTE, N.C. — A federal appeals court has upheld the conviction of a North Carolina ear, nose and throat doctor who reused single-use surgical devices on over 1,400 Medicare patients and defrauded ...