Moon Surgical, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for two major advancements ...

The US FDA has granted 510(k) clearance to PathAI for its digital pathology image management system, AISight Dx.

Press Release DESKi, a healthtech company developing AI-powered diagnostic tools in collaboration with clinicians and researchers, today announced the close of a $6 million seed round to support the U ...

This milestone builds on growing momentum for HeartFocus, which recently received FDA clearance, along with a Predetermined Change Control Plan (PCCP) that makes it easier to update and expand the ...

GOP Rep. Marjorie Taylor Greene of Georgia, an outspoken COVID-19 vaccine critic, blasted the FDA's green lighting of the mNEXSPIKE as "Not MAHA at all!!!" in a tweet ...

PARIS–(BUSINESS WIRE)–BrightHeart, a global leader in artificial intelligence (AI) solutions for obstetrics and pediatric cardiology, announced today it has received 510(k) clearance from the U.S.

Nachrichten » BrightHeart Obtains Third FDA Clearance and PCCP Approval, Becoming First to Offer One Integrated Solution for Real-Time Fetal Heart Documentation and CHD Detection ...

BrightHeart, a global leader in artificial intelligence (AI) solutions for obstetrics and pediatric cardiology, announced today it has received 510(k) clearance from the U.S. Food and Drug ...

The U.S. Food and Drug Administration (FDA) has started to address this challenge through its Predetermined Change Control Plan (PCCP), a framework that allows manufacturers to make specific AI ...