A model may perform exceptionally well and still lack the evidence package necessary to support regulatory review.

New standards framework introduces maturity model and certification program designed to help organizations evaluate ...

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 ...

GE HealthCare Technologies Inc. (NASDAQ:GEHC) is one of the best young stocks to invest in according to hedge funds. On June 4, GE HealthCare received FDA 510(k) clearance for MIM Contour ProtégéAI+ 2 ...

ECG-based AI screening tool for moderate to severe aortic valve stenosis joins select group of devices granted accelerated FDA engagement AccurKardia, an innovator in ECG-based diagnostics technology, ...

Medical device manufacturers developing digital health products face a recurring question: Will the U.S. Food and Drug Administration (FDA) regulate this product? Many digital health products can ...

This voice experience is generated by AI. Learn more. This voice experience is generated by AI. Learn more. Researchers are increasingly using AI and biotechnology tools to better understand the ...

Please provide your email address to receive an email when new articles are posted on . The update adds 250 kHz scan speed for OCT angiography and green autofluorescence for macular imaging. The ...