Lifecare announced today that it has formal preparations underway to submit its implantable continuous glucose monitor (CGM) for CE mark.
Bergen, Norway-based Lifecare said in a news release that it began its work on CE mark approval six weeks ago. It aims to bring its CGM system to Europe as a regulated medical device by the end of 2026. That includes all components of the system — the sensor, implant and reader, plus manufacturing processes and documentation.
The company said its work “firmly” places it on the regulatory pathway to market readiness. This follows last month’s announcement that the company completed the initial electromagnetic compatibility (EMC) testing of electronics developed for its next-generation CGM implant. EMC testing ensures that the implant can operate reliably when surrounded by mobile phones, Wi-Fi and other wireless technologies without interference or failure.
Learn more about implantable CGMs and other diabetes technology in our special report>>
“Initiating the full CE preparation phase – with substantial progress already achieved – is both a technical milestone and an important public statement of where we stand,” says Joacim Holter, CEO of Lifecare ASA. “It demonstrates our readiness to deliver a regulated medical device to market and our ability to build on the strong foundation already established through CE compliance work on the electronics of our proven implant.”
Lifecare develops miniaturized sensor technology that measures changes by reading osmotic pressure variations. The implantable CGM monitors changes in an osmotic pressure chamber, induced by changes in the interstitial fluid glucose concentrations in the subcutaneous tissue.
Implantable CGMs could rival the devices made by minimally invasive CGM leaders Dexcom and Abbott. Read more about Senseonics’ commercial CGM implant and Glucotrack’s long-term blood glucose monitor implant under development.
