CoAxia is out of money in the wake of an unfavorable neurological devices panel meeting about its de novo application for expanded use of its NeuroFlo catheter. The firm says FDA mishandled the meeting, the first public panel meeting for a de novo submission.
After spending two years trying to attain clearance for an expanded use of the NeuroFlo catheter system to treat patients with acute ischemic stroke within 14 hours of symptom onset, CoAxia Inc. is out of money, and has one remaining employee.
CoAxia CEO Andrew M. Weiss says he remains hopeful that the agency will ultimately grant de novo classification for NeuroFlo...
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.
