Medical sensor specialist Lifecare ASA (OSE:LIFE) has submitted an application for regulatory approval to begin its first human clinical trial for a wireless continuous glucose monitoring (CGM) implant, the company announced on Tuesday.
The filing follows a finalised design phase, supporting trial preparations and continued progress in manufacturing development.
This milestone aligns with Lifecare's clinical and commercial roadmap, marking a significant step toward CE-mark certification.
Regulatory approval is anticipated in the third quarter of 2025, with trial completion expected by early fourth quarter, subject to timely authorisation.
Lifecare aims to begin its pivotal CE-mark clinical trial later this year, targeting completion in 2026.
Commercial launch of the CGM implant for human use is planned for 2027.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA