Intraoperative Real-Time AI Pathology Diagnosis System PathLens Receives EMA Approval: Pathology Reports in 10 Minutes on the Operating Table
PathLens system uses portable microscopy and AI image analysis to determine tissue malignancy in real time during surgery, reducing pathology diagnosis time from days to 10 minutes.
French medical AI company PathLens received European Medicines Agency (EMA) approval on February 25 for its intraoperative real-time pathology diagnosis system, which can complete tissue benign-malignant determination in 10 minutes on the operating table. Traditional pathology diagnosis requires sending tissue samples to pathology departments for fixation, sectioning, staining, and microscope examination by pathologists, typically taking 3 to 7 days.
PathLens consists of a portable confocal microscope and AI analysis software. After removing a tumor, the surgeon places the probe directly on the tissue surface. The microscope captures cell morphology images at 200x magnification, and the AI model completes analysis in 90 seconds, providing a malignancy probability score.
In a prospective trial involving 3,400 breast cancer surgeries, PathLens achieved a malignant interpretation accuracy of 96.2% with a false negative rate of 1.1%. The system is already in use at 35 hospitals in France, Germany, and Italy.
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