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Lifecare AS ( (DE:LFC0) ) just unveiled an update.
Lifecare ASA reported that the Norwegian Medical Products Agency has completed its review of the company’s application to start a first-in-human clinical investigation of its implantable continuous glucose monitoring sensor. Regulators found the current documentation insufficient for authorization and requested further technical data and clarifications before granting approval.
The company stressed that such regulatory feedback is typical for innovative first-in-human MedTech studies and does not challenge the scientific rationale or intended use of the device. Lifecare views the input as constructive guidance on strengthening biocompatibility, sterilization, manufacturing controls, and other validation documents, and has engaged LINK Medical to support a revised submission as it continues toward clinical validation and eventual commercialization of its CGM technology.
More about Lifecare AS
Lifecare ASA is a Norwegian MedTech and medical sensor company focused on developing next-generation implantable Continuous Glucose Monitoring systems. Its technology is based on osmotic pressure sensing and is intended for measuring glucose and other analytes in humans and pets, targeting improved long-term monitoring solutions in the diabetes and broader health monitoring markets.
YTD Price Performance: -66.20%
Average Trading Volume: 2,767,342
Current Market Cap: NOK73.37M
For an in-depth examination of LFC0 stock, go to TipRanks’ Overview page.