New data aggregated from over 5,000 reported adverse events suggests that patients should be aware of risks using MitraClip for TEER and operators should take more caution in handling the device.
Researchers advise caution when using Abbott’s MitraClip device during transcatheter edge-to-edge repair (TEER) procedures, a new study of over 5,000 adverse event reports concludes.
The paper was published 18 January in JACC: Cardiovascular Interventions. Researchers explored national MitraClip outcomes through the US Food...
To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
The US FDA has issued an updated final guidance document on cybersecurity considerations for medical device manufacturers that replaces a previous final guidance the agency issued in 2023.
Amendment brings new benefits for device accessories and aesthetic devices used by healthcare professionals.
Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.
Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.
The rate at which new documents to support the implementation of EU medtech regulations are issued has slowed of late; but June bucked the trend, with a flurry of activity.
