The US FDA has cleared an AI-based diagnostic from Israeli firm AEYE Health that screens for diabetic retinopathy, a leading cause of blindness.
AEYE Health has developed an automated diagnostic tool that could prevent millions of diabetics from losing their sight.
The Tel Aviv based digital health company recently announced it received 510(k) clearance from the US Food and Drug Administration for its screening system to detect retina damage in patients...
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
