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CDRH Launches ‘Innovation Pathway 2.0’ With End-Stage Renal Devices

Participants expect the program to tangibly reduce time to market and improve companies’ prospects for raising money.

Device companies are getting a first chance to participate in CDRH’s innovation pathway pilot focused on early, hyper-collaboration between sponsors and reviewers under a new stage of the program announced April 9.

FDA has selected three investigational-stage devices for end-stage renal disease as part of its innovation pathway 2.0 program.

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• By Natasha Barrow

TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

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.

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