News

What The FDA's Guidance On AI-Enabled Devices Gets Right And Wrong
There’s no questioning that AI should have governance and guardrails. As much good as it can bring, it also heightens risk.
Forbes1y
FDA Medical Device Cybersecurity And SBOMs: Compliance And Potential
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.
Healthcare IT News1y
FDA medical device loophole could cause patient harm, study warns
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 ...
Hosted on MSN11mon
Almost half of FDA-approved AI medical devices are not trained on ... - MSN
Most notably, 226 of 521 FDA-approved medical devices, or approximately 43%, lacked published clinical validation data.
Healthcare IT News1y
It's time FDA and CISA update their medical device agreement, says GAO
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 ...
FierceBiotech4mon
FDA's novel medical device clearances slow to a crawl
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 ...