Updates in the FDA’s Regulation of Digital Health Technologies
The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software...
Cochlear Implant Developer Agrees to Pay for Alleged False Claims to FDA
Cochlear implant developer Advanced Bionics LLC will pay about $12 million to resolve allegations that it misled federal health care programs, the United States Department of Justice (DOJ) announced. The...
