The approval comes less than a week after FDA approved Edwards' Sapien 3 third-generation transcatheter aortic replacement valve. Both devices were approved based on short-term outcomes data instead of the two-year data FDA has required of TAVR systems in the past.
FDA has approved Medtronic PLC's CoreValve Evolut R transcatheter aortic valve replacement system, the second next-generation TAVR device the agency has approved in the last few weeks based on short-term outcomes data.
The Evolut R approval, and the recent approval of Edwards Lifesciences Corp.'s Sapien 3 TAVR system, signals a continuation of the very tight competition between the two firms in...
TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.
The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.
Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.
