Bergen, Norway, 8 July 2025 -- Lifecare ASA (LIFE), a MedTech company
developing next-generation Continuous Glucose Monitoring (CGM) technology for
diabetes management, is pleased to announce the successful completion of
official radio frequency compliance testing of wireless system for use in its
implantable CGM system.
The successful completion of radio frequency (Rf) compliance testing follows
Lifecare's recent announcement of electromagnetic compatibility (EMC) testing,
marking yet another important milestone in the company's CE-marking process
and broader regulatory roadmap. Rf testing verifies that wireless medical
devices---such as Lifecare's CGM implant---can operate safely and reliably
within the regulatory guidelines for wavelength and emission strength without
causing interference to other electronic equipment. Meeting these strict
European safety standards confirms that the device is suitable for use around
people and in everyday environments. This achievement is a critical step
toward initiating human clinical trials and ultimately securing market
approval.
The latest results confirm that Lifecare's wireless CGM system---consisting of
a miniaturized injectable implant and a lightweight external readout device
--- complies with stringent European standards for radio performance and
safety. Conducted by accredited lab ShortLink Compliance AB, the testing
evaluated the device's wireless communication, signal stability, and safe
operation under a range of real-world conditions.
"Achieving radio frequency compliance is yet another important milestone for
Lifecare," said Joacim Holter, CEO of Lifecare ASA. "It confirms that our
wireless system for readout from our implant meets the highest safety and
performance standards. Alongside our earlier EMC results, this strengthens the
technical foundation of our solution and supports our next step---initiating
clinical trials and advancing toward CE-marking."
With Rf compliance confirmed, Lifecare's regulatory submission remains on
track as the recent results from EMC tests confirmed a stable technical
foundation for the electronics used in our implant. As previously
communicated, Lifecare expects final EMC verification activities to be
finalized within three months. Pending final approval, the first human
clinical trial is scheduled to begin in Q3 2025 and conclude in Q4
2025---supporting the company's pathway toward CE-marking and a commercial
launch in 2027.
Lifecare's CGM technology is designed to transform diabetes care by providing
continuous glucose data by means of the company's proprietary implant with
wireless readout technology. These technical validations not only advance
clinical readiness - but they also strengthen confidence in the system's
market potential.
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