News

There’s no questioning that AI should have governance and guardrails. As much good as it can bring, it also heightens risk.
SBOMs And The Future Of Medical Device Cybersecurity Compliance and regulations can support product development in a positive way. The FDA mandate fits in this category.
Others have said that the FDA regulatory framework around AI as medical devices could be curtailing innovation. During a discussion of the practical application of AI in the medical device industry in ...
Most notably, 226 of 521 FDA-approved medical devices, or approximately 43%, lacked published clinical validation data.
Cybersecurity protocols in FDA's medical device premarket review submissions were not required until March 2023. "As such, a device manufacturer who made a submission before March 2023 would not be ...
According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device clearances. That includes the Jan. 17 green light of Myocene’s ...