Even if manufacturing challenges don’t derail the 2025 launch plans, the regulatory setback introduces new challenges for Dexcom’s continuous glucose monitors at a time when competition from Abbott and Medtronic is intensifying.
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Biolinq plans to use the proceeds of its new venture funding to support US FDA de novo review, automation engineering and commercialization efforts with partners, CEO Rich Yang told Medtech Insight.
Only 14% of people with type 2 diabetes use continuous glucose monitors, although 93% of users report a positive impact on their health. Dexcom is ramping up efforts to close this adoption gap.
Dexcom announced it received US clearance for its 15-day CGM, which has a MARD of 8.0% and is expected to launch in the second half of 2025 to allow for integration with insulin pumps.
After switching production of coatings for its continuous glucose monitors in-house to improve supply, Dexcom ran afoul of US FDA for failing to submit a premarket notification. Firm says launch of 15-day sensor will not be delayed by the problems.
International device regulatory group IMDRF has issued a new playbook on “regulatory reliance,” which allows regulators to make use of assessments performed by trusted regulatory partners. The document is the first to offer a detailed guide on developing and implementing these agreements.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
Exer Labs Inc.’s website marketed its AI-based Exer Scan app to “screen and treat Parkinson’s, TB, Cerebral Palsy and more.” But those claims went well beyond what was allowed under the product’s 510(k) clearance, US regulators say.
