March 22 (Reuters) - Median Technologies SA ALMDT.PA :
* ANNOUNCES DESIGN COMPLETION OF ITS IBIOPSY® LUNG CANCER
SCREENING END-TO-END CADE/CADX SOFTWARE AS MEDICAL DEVICE (SAMD)
WITH OUTSTANDING SENSITIVITY & SPECIFICITY PERFORMANCE
* IBIOPSY® LUNG CANCER SCREENING (LCS) CADE/CADX1OUTSTANDING
PERFORMANCE REACHES 94.7% SENSITIVITY2 AT 93.3% SPECIFICITY3,
BASED ON A COHORT OF 1,760 PATIENTS
* HAS STARTED REGULATORY ENGAGEMENT AND DESIGN OF PIVOTAL
CLINICAL
STUDIES FOR IBIOPSY® LCS CADE/CADX SAMD, AND AIMS TO OBTAIN A US
FDA APPROVAL AND MARKET AUTHORIZATION BY END 2023
Source text for Eikon: ID:nBw4t9HXsa
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