Brief: Lifecare Receives Regulatory Feedback On First-In-Human Application
10/03/2026 07:38
March 10 (Reuters) - Lifecare ASA LIFEA.OL: NORWEGIAN MEDICAL PRODUCTS AGENCY (NOMA) COMPLETES REVIEW OF FIRST-IN-HUMAN CGM STUDY APPLICATION NOMA SAYS DOCUMENTATION NOT SUFFICIENT TO AUTHORISE CLINICAL INVESTIGATION APPLICATION FORMALLY REJECTED AT THIS STAGE; COMPANY TO RE-SUBMIT WITH ADDITIONAL DOCS/CLARIFICATIONS FEEDBACK MAINLY ON TECHNICAL DOCUMENTATION/VALIDATION (BIOCOMPATIBILITY, STERILISATION, MANUFACTURING CONTROLS) SAYS FEEDBACK DOES NOT PRIMARILY CONCERN SCIENTIFIC RATIONALE OR INTENDED USE ENGAGES LINK MEDICAL AS ADVISER FOR RE-SUBMISSION AND FINAL PHASE TOWARD APPROVAL IMPLANTABLE CGM USES OSMOTIC PRESSURE SENSING; PLANNED STUDY TO ASSESS ACCURACY/PERFORMANCE IN HUMANS Source text for Workspace: nMFNbZMBRY Further company coverage: LIFEA.OL (Gdansk Newsroom) ((gdansk.newsroom@thomsonreuters.com; +48 58 769 66 00;))