Quality systems and Medical Device Reporting violations were noted by US FDA investigators during an on-site inspection of Medtronic’s Northridge, CA, facility. A total of seven device-related warning letters were released by the agency last month.
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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.
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.
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.
For the fourth time in as many years the FDA has issued a communication concerning a key accessory from Olympus used in several types of urological procedures. This time, however, the agency has added a class I recall confirmation to its original early alert on the device issued in December 2024. A device safety specialist provided Medtech Insight with a deeper understanding of the problem as well as overall scope safety.
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.
A new set of clinical lab regulations, which came into effect in January, include higher fees, an expanded set of possible consequences for labs that are not in compliance, and revised employee standards.
