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An announcement from Lifecare AS ( (DE:LFC0) ) is now available.
Lifecare ASA has submitted updated documentation to the Norwegian Medical Products Agency (NoMA) to progress its application to start a first-in-human clinical study of its implantable continuous glucose monitoring system. The new submission addresses procedural and technical clarifications related to biocompatibility, sterilization, manufacturing controls and presentation of preclinical data under the EU Medical Device Regulation, with NoMA having previously raised no concerns about the study’s scientific rationale or risk-benefit profile. With 26 review days remaining and a decision still expected within the first quarter of 2026, the pilot trial at the University of Bergen will assess the accuracy and clinical performance of Lifecare’s CGM technology and is seen as a key milestone toward a pivotal CE-marking study, potentially advancing the company’s regulatory pathway and competitive position in the CGM market.
More about Lifecare AS
Lifecare ASA is a Norwegian MedTech and medical sensor company developing next-generation continuous glucose monitoring (CGM) systems for diabetes management, using osmotic pressure as its sensing principle. Its proprietary implantable sensor technology is designed to detect and monitor a wide range of analytes and molecules in humans and pets, positioning the company in the advanced biosensing and digital health market.
Average Trading Volume: 856,370
Current Market Cap: NOK96.58M
See more data about LFC0 stock on TipRanks’ Stock Analysis page.