The company is sponsoring an early feasibility trial of the Intrepid transcatheter valve replacement system for patients with severe tricuspid regurgitation.
The US Food and Drug Administration approved Medtronic's plan for a feasibility trial of its Intrepid transcatheter valve replacement system for treating tricuspid regurgitation, the company announced on 9 September.
The FDA also granted Intrepid its breakthrough device designation, indicating the agency believes the device could provide important clinical benefits...
A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
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.
As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.
