Browsing Tag
FDA De Novo
2 posts
EMVision (ASX:EMV) ramps up stroke scanner trial with full site activation, algorithm updates, and U.S. expansion
EMVision’s emu scanner trial is gaining momentum across top U.S. and Australian hospitals. Find out how AI upgrades and regional pilots may shape FDA clearance.
PainChek (ASX: PCK) stock climbs on FDA approval — is this the breakout investors expected?
PainChek Ltd (ASX: PCK) gains FDA De Novo clearance for its AI pain-assessment app, sparking a stock rally and opening a US $100 million market in US aged care.