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Lifecare achieves full radio frequency compliance for CGM implant – clearing the way for CE mark of electronics
Prenumeration
Beskrivning
| Land | Norge |
|---|---|
| Lista | Oslo Bors |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
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.