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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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