Lifecare ASA Secures REK Ethics Approval For First-In-Human CGM Trial

(RTTNews) - Lifecare ASA (LIFE-ME.OL), on Tuesday, said it has received approval from the Regional Committee for Medical and Health Research Ethics or REK in Norway for its upcoming first-in-human trial of its implantable CGM sensor.

This approval marks a pivotal milestone toward regulatory validation of Lifecare's wireless glucose sensor, designed for individuals with type 1 diabetes. The trial will evaluate the sensor's safety, tolerability, and glucose-sensing precision in a clinical setting.

While the ethics approval indicates strong foundational support, it remains conditional pending minor documentation updates. Lifecare is currently awaiting final trial authorization from the Norwegian Medicines Agency (Direktoratet for medisinske produkter).

The study will be conducted across clinical sites in Norway and Germany, in collaboration with academic and clinical partners. The ethics greenlight follows recent technical validations confirming the device's compliance with core RF and electromagnetic compatibility standards.