Medical Design & Outsourcing

FDA rules, regulations and resources for artificial intelligence in medical devices

Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...

LIGHT AI ANNOUNCES INITIATION OF FDA PIVOTAL CLINICAL TRIAL FOR QUICKSCAN™ STREP A SOFTWARE AS A MEDICAL DEVICE (SaMD)

Light AI Inc. ("Light AI" or the "Company") (CBOE CA: ALGO) (FSE: OHC) (OTCQB: OHCFF), a digital healthcare technology company focused on developing artificial intelligence ("AI") health diagnostic ...
RAPS

FDA revamps device software premarket submissions guidance

Editor's Note: A previous version of this article incorrectly stated the guidance did not apply to device constituent parts of a combination product. The US Food and Drug Administration (FDA) this ...

FDA Cyber Guidance Sets Priorities for Medical Device Companies

Opinion: In response to the FDA's updated cybersecurity guidance on medical devices, manufacturers should follow "secure by design" principles, ensure cyber transparency, conduct threat modeling, and ...

FDA Grants Coredio Breakthrough Designation for AI Platform Bringing Advanced Heart Failure Assessment Beyond the Hospital

AI-powered platform uses consumer wearables to help clinicians monitor heart failure patients beyond the hospital SANTA CLARA, Calif.--(BUSINESS WIRE ...
JD Supra

Automation Bias and Clinical Practice: FDA Makes Incremental Updates to Clinical Decision Support Software Guidance

On January 6, 2026, the US Food and Drug Administration (FDA) revised its final guidance on Clinical Decision Support Software (2026 CDS Software Guidance). 1 The 2026 guidance, which supersedes the ...
Medical Device and Diagnostic Industry (MD+DI)

FDA Adds New Submission Category in Human Factors Guidance Shake-Up

FDA revises 2022 human factors guidance with new risk-based categories, device modification examples, and 60-day ...
Hosted on MSN

FDA scraps ‘Final Rule’ classifying LDTs as medical devices

The US Food and Drug Administration (FDA) has chosen to axe its ‘Final Rule’ from May 2024, bringing to an end a long-running agency-industry dispute around the proposed classification of ...
RAPS

FDA updates manufacturer communications guidance to emphasize application to devices

The US Food and Drug Administration has updated its draft guidance on how the drug and medical device makers should communicate with payors and other stakeholders about their products. The updates are ...