Key Takeaways - FDA’s 2026 guidance clarifies when digital health tools fall outside device regulation. Updated policies for clinical decision ...
Medical Device Network on MSN
FDA clears RevealDX’s AI lung nodule diagnostic
RevealDX’s software analyses CT scans and assigns lung nodules with a Malignancy Similarity Index score to aid in lung cancer diagnosis.
Another digital law for the healthcare system is in the works. Users want user-friendly systems, and the industry wants ...
The FDA's approval process was designed for medical devices that stay largely the same after launch. Clinical AI does not ...
As China released a high-tech medical device to help some 23 million children suffering from attention deficit hyperactivity ...
On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support (CDS) ...
Understand the advantages of PC-driven hearing tests over legacy equipment in terms of cost, scalability, and usability.
Has CDSCO Guidance Changed The Rules? Legal News and Analysis - India - Regulatory & Compliance - Conventus Law ...
MedCognetics, Inc., a company focusing on medical imaging AI, today announced it has received U.S. Food and Drug Administration (FDA) ...
Forus Health secures CDSCO approval for AI-led diabetic retinopathy screening tool in India: Our Bureau, Bengaluru Wednesday, February 4, 2026, 15:45 Hrs [IST] Forus Health, a lea ...
Bio-inspired medical devices can gather more data than ever before, and HPC/quantum will massively speed up discovery rates; consumer self-testing will be slower.
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