After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight over LDTs. If finalized as proposed, FDA would ...
FAYETTEVILLE, Ark.--(BUSINESS WIRE)--Namida Lab, the world leader in tear-based diagnostics, today announced the launch of Auria™, a first-of-its-kind breast health assessment test. Backed by ...
Current regulatory frameworks for artificial intelligence-based clinical decision support (AICDS) are insufficient to ensure safety, effectiveness, and equity at the bedside. The oversight of clinical ...
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