FDA Approval

Boston - June 30, 2025  -  PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AISight®...

[CORRECTED RELEASE] Updated to clarify reference to dual-scanner FDA clearance. PARIS, FRANCE / ACCESS Newswire / May 21, 2025 / Tribun Health, a leader in digital pathology, proudly announces that its flagship web-based image management...

The VENTANA DP 600 slide scanner, part of Roche's Digital Pathology Dx system, is now cleared by the FDA to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images. This 240-slide scanner produces...

Paige Lymph Node is recognized by the FDA as a breakthrough device to assist pathologists in the detection of breast cancer metastases in lymph node tissue NEW YORK--(BUSINESS WIRE)--Paige, a global leader in end-to-end digital...

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