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AI, digital health feature in latest batch of FDA breakthrough device designations

First published on
FDA has issued another batch of breakthrough device designations. The latest crop sees the agency grant regulatory privileges to a set of AI and digital health companies including
Koios Medical and
Nēsos.
Koios landed breakthrough status for AI software designed to enable the early detection of breast and thyroid cancer. The software analyzes breast and thyroid ultrasound images to help radiologists determine if a biopsy is needed. Koios is pitching the system as a way to both prevent unnecessary biopsies of benign tissues and improve cancer detection rates.
Perimeter Medical Imaging AI also secured breakthrough designation for an AI-enabled approach to imaging. FDA awarded the status to Perimeter s Optical Coherence Tomography Imaging System coupled with ImgAssist AI. The imaging system, which is already cleared by FDA in the evaluation of excised human tissue microstructure, is designed to provide real-time, ultra-high-resolution images. ....

Koios Medical , Optical Coherence Tomography Imaging System , Implandata Ophthalmic Productsreceived , Cure Medical , Quadrant Bioscience Clarifi , Medical Solutionsreceived , ஒளியியல் இணக்கத்தைப் டோமோகிராபி இமேஜிங் அமைப்பு , குணப்படுத்த மருத்துவ ,

Tuesday's analyst upgrades and downgrades - The Globe and Mail

Tuesday's analyst upgrades and downgrades - The Globe and Mail
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