Bifogade filer
Lifecare completes production-level compliance testing of implant electronics - moves to finalize CE claim
Prenumeration
Beskrivning
| Land | Norge |
|---|---|
| Lista | Oslo Bors |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
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Bergen, Norway, 17 February 2026 - Lifecare ASA (LIFE), a MedTech company developing next-generation implantable Continuous Glucose Monitoring (CGM) technology, today announces the successful completion of final compliance testing of the electronics used in its implant system, marking a decisive regulatory development.
The completed testing has been performed on electronics used in implants manufactured under Lifecare’s reproducible and quality-controlled production protocol - the same structured batch currently deployed in the ongoing longevity study (LFC-SEN-002) and planned deployed in Lifecares First-In-Human study (pending approval) and for the commercial veterinary version.
Compliance testing of electronics used in the reproducible manufacturing batch validates the electronics architecture at production level - not merely at prototype stage. This confirms that the electronics platform underpinning the Company’s implant system is both regulatory compliant and manufacturing robust.
The testing program builds on previously communicated electromagnetic (EMC) and radio frequency (RF) compliance activities and includes verification of the fully finalized system configuration.
All required laboratory testing has been successfully executed according to applicable European standards. Lifecare is currently awaiting the final consolidated test report from the accredited laboratory. Upon receipt, Lifecare will finalize and sign the technical file required to formally claim CE marking of the electronics module.
Importantly, the electronics configuration validated through this process is the same architecture used in:
- The reproducible implant manufacturing batch,
- The implants currently deployed in the longevity study, and
- The first planned commercial veterinary product version.
No further design adjustments to the electronics are planned.
“Electronics used in implantable medical devices are subject to particularly rigorous safety and reliability requirements. Unlike external devices, implant electronics must operate safely inside the body over extended periods without posing electrical, thermal or electromagnetic risk. Our electronics platform meets the stringent standards required for implantable use, strengthening both our regulatory position and our readiness for commercialization,” says Joacim Holter, CEO of Lifecare ASA.