This initial testing of the electronics for use in our implant with wireless communication includes electromagnetic compatibility (EMC) and Radio Frequency (Rf). The first EMC tests of electronics were completed by ShortLink Compliance AB and reported to Lifecare.

EMC testing checks whether the electronics used in our implant and read-out unit will function correctly in the real world, where it will be surrounded by things like mobile phones, Wi-Fi, and other wireless technologies. The results from our first EMC tests confirm a stable technical foundation for the implant system, validating the core system performance under standard EMC conditions, supporting the next phase of refinement and final verification.

The results mark an important milestone in the company’s CE-marking process and broader regulatory strategy.

“We are pleased with the outcome of this testing round, which confirms that our electronics perform according to expectations at this preclinical stage,” said Joacim Holter, CEO of Lifecare ASA. “This is a planned and productive step in our quality assurance process, and we are now moving forward with optimizations to secure full regulatory compliance.”

While final adjustments will be implemented to prepare for the final round of compliance testing of electronics, Lifecare stays on track to start the first-in-human clinical trials this year, as previously announced. Lifecare anticipates completing the regulatory testing phase in time for CE-mark submission in 2026 and commercial launch in 2027.

The testing was conducted by ShortLink Compliance AB, an independent certified lab, using internationally recognized standards. The process was supported by a special high-activity operating mode designed to push the system to its limits and confirm reliability under demanding conditions. Lifecare anticipates completing final verification activities within three months.