DR, an AI-powered screening software designed to detect more than mild diabetic retinopathy in adults with diabetes, ...

Pharmaceutical, medical device, and biotechnology industries live and breathe regulation. Every computerized system that impacts product quality, patient data, or manufacturing processes must go ...

Beyond Installation, Operational, and Performance Qualifications: A Risk-Based Validation Framework for AI-Driven Software in ...

FDA tied AI-assisted drafting directly to established Quality Unit accountability under 21 CFR 211.22(c) for approving/rejecting specifications and procedures affecting identity, strength, quality, ...

With increasing interest in and demand for patient-specific medical devices, such as anatomically matched 3D printed implants ...

As AI transforms biology, longevity startups are attracting investors, advancing toward clinical milestones, and reshaping the future of aging research.

SAN FRANCISCO--(BUSINESS WIRE)--Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced today that the U.S. Food and Drug ...

Consider a hypothetical scenario that reflects a pattern increasingly reported by manufacturers: a 510(k) submission for an AI-powered diagnostic tool with 99% sensitivity. Strong numbers. Solid ...

A tiny brain implant, no bigger than a blueberry, is moving from lab concept to human testing in the United States. Motif Neurotech has secured clearance from the U.S. Food and Drug Administration to ...

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies ...

TechCrunch Disrupt Battlefield 2023 winner BioticsAI announced on Monday that it has received FDA clearance for its AI software that helps detect fetal abnormalities in ultrasound images. The product ...