How Do You Solve a Problem Like AI Regulation?
How the current FDA AI/ML device regulations may be impeding innovation in the clinical lab
How the current FDA AI/ML device regulations may be impeding innovation in the clinical lab
Lab leaders say that the increased level of scrutiny proposed for such tests would be a detriment to innovation and patient care.
The recently proposed TCET rule appears to be too stringent to significantly hasten the Medicare coverage process for device makers.
The bill is designed to provide Medicare patients faster access to innovative technology approved by the FDA.
Product integration collaborations have become increasingly common, with five such deals being announced between February and mid-March.