Bergen, Norway, 13 August 2025 -- Lifecare ASA (LIFE), a MedTech company
developing next-generation Continuous Glucose Monitoring (CGM) technology for
diabetes management, is pleased to announce that formal preparations towards
CE marking of its CGM as a fully regulated medical device have been underway
for the past six weeks.
Lifecare has started the formal preparations to document regulatory compliance
and achieve CE mark for its CGM system as a fully regulated medical device,
according to our communicated plan, by end of 2026. This phase encompasses the
full CGM system - sensor, implant, reader, manufacturing processes, and
comprehensive ISO 13485-compliant documentation, the international recognised
quality standard for medical devices - firmly placing Lifecare on the
regulatory pathway to market readiness.
"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 has previously announced important compliance achievements for the
electronics within our CGM system, with final CE compliance for the electronic
components expected by end of Q3 2025. This advancement is a partial step
towards full regulatory compliance for Lifecares CGM as a medical device.
Initiating CE mark preparations require more than having a working device --
it demands proof that every device manufactured will meet the same rigorous
standards of safety, performance and quality. This process is comparable to
creating an end-to-end instruction manual and safety log for the entire
lifecycle of the product -- covering every design decision, supplier,
material, and manufacturing step -- and ensuring each one can be repeated
exactly, without compromise. This proof comes from a formalised Quality
Management System, supported by an extensive framework of interlinked,
traceable and auditable documents, including detailed design records, risk
analyses, supplier quality agreements, manufacturing instructions, inspection
reports, and test protocols.
Such documentation is the foundation for regulatory approval, ensuring
consistent, reproductible and safe manufacturing for human use. We are
continuing our strong cooperation with TTP as a highly valued development
partner, ensuring that we meet all the stringent regulatory standards required
to deliver a device ready for market introduction.
As Lifecare advances through this complex and highly structured regulatory
process, each completed step further solidifies our position as a company on
the verge of market introduction -- not only showcasing our technical
capability but also sending a clear signal to stakeholders, partners, and the
market that Lifecare is ready to deliver.
About us
Lifecare ASA is a medical sensor company developing technology for sensing and
monitoring of various body analytes. Lifecare's focus is to bring the next
generation of Continuous Glucose Monitoring ("CGM") systems to market.
Lifecare enables osmotic pressure as sensing principle. Lifecare's sensor
technology is suitable for identifying and monitoring the occurrence of a wide
range of analytes and molecules in the human body and in pets.
Contacts
For further information, please contact:
Joacim Holter, CEO, joacim.holter@lifecare.no, +47 40 05 90 40
Renete Kaarvik, CFO, renete.kaarvik@lifecare.no, +47 94 83 82 42