de novo FDA clearance
The company's CEO defended its feature as a wellness tool under the 21st Century Cures Act, combating the FDA’s claim that it qualifies as a regulated medical device.
This half of the year the FDA has named a new comissioner, continued working on the much anticipated Pre-Cert program and collaborated with the NIH on a new app.
The agency also warned consumers of unregulated diabetes products and outlined plans for AI device regulation.
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.