Lifecare receives preliminary assessment for first-in-human study

Lifecare ASA, a medtech company developing Continuous Glucose Monitoring (CGM) technology, announced a preliminary assessment from the Norwegian Medical Products Agency (NoMA) for its first-in-human clinical study application. NoMA's request for additional information pertains to procedural and technical clarifications typical for implantable devices, without questioning the scientific rationale or risk-benefit basis of the study. This aligns with standard regulatory procedures for complex medical devices under Regulation (EU) 2017/745 (MDR).

NoMA has utilized 39 of the standard 45 review days, with the clock now paused. Upon submission of Lifecare's updated documentation, NoMA will have 26 days to complete its assessment, reflecting an MDR-permitted 20-day extension for expert input. Lifecare expects to submit its response in the coming weeks, anticipating a final decision in Q1 2026. The pilot study, supervised by professor Simon Dankel at the University of Bergen, will evaluate the accuracy and clinical performance of Lifecare's proprietary CGM system.

The company emphasizes that it will not commence implant production before NoMA grants authorization, ensuring the study timeline aligns with the regulatory process. Data from this pilot study will be crucial for Lifecare's pivotal CE-marking trial planned for 2026, supporting the company’s objective for a European market launch in 2027. Lifecare's technology leverages osmotic pressure for sensing, applicable to a wide range of analytes in humans and pets.