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Medical Device Network on MSN18h
PathAI’s digital pathology image management system gains FDA clearance
The US Food and Drug Administration (FDA) has granted 510 (k) clearance to PathAI for its digital pathology image management ...
Morningstar2d
PathAI Receives FDA Clearance for AISight® Dx Platform for Primary Diagnosis - Morningstar
The FDA decision also included a Predetermined Change Control Plan (PCCP), enabling PathAI to validate and implement specified major changes such as additional displays, scanners, file formats and ...
Yahoo Finance1mon
BrightHeart Obtains Third FDA Clearance and PCCP Approval, Becoming First to Offer One Integrated Solution for Real-Time Fetal Heart Documentation and CHD Detection - Yahoo Finance
PARIS, May 14, 2025--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 ...
Yahoo Finance1d
PathAI Receives FDA Clearance for AISight® Dx Platform for Primary Diagnosis
The FDA decision also included a Predetermined Change Control Plan (PCCP), enabling PathAI to validate and implement specified major changes such as additional displays, scanners, file formats and ...