de novo FDA clearance
The regulatory changes also come alongside Pre-Cert Program updates and roughly a dozen noteworthy digital health approvals.
As AI cements its role in healthcare, more and more intelligent software offerings are pursuing 510(k) and De Novo approvals.
In the last year the FDA has taken steps to evolve its process for regulating software as a medical device, personal genomics and clinical decision support technology.
A collection of 34 approvals and clearances by the US Food and Drug Administration during Q3 and beyond.
Interest in digital health is now sprouting up all over DC, from the president’s announcement of a new AI task force to FDA Commissioner’s shout out to digital health in his budget request.