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...
Navigating the Regulatory Landscape: FDA Clearance and Patent Protection for Software as a Medical Device
Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves navigating complex and...
