The U.S. FDA finally granted Abbott Laboratories' Freestyle Libre 2 clearance as an integrated continuous glucose monitor (iCGM) for adults and children age 4 and older with diabetes. Abbott received CE mark for the device more than 18 months ago and discussed its submission to the FDA in an earnings call over a year ago. Abbott expects the device to be available at pharmacies and durable medical equipment suppliers within weeks.
San Diego startup Glysens Inc., which is developing implantable continuous glucose monitoring (ICGM) technology, closed a $15 million incremental financing. The funds will be used to support ongoing clinical trials and development of the company’s fully implanted, long-term CGM systems.