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Story summary
- U.S. President Donald Trump announced RAPID pathway to speed Medicare coverage for FDA breakthrough devices.
- CMS Deputy Director John Brooks said coverage may be granted within 60-90 days of FDA approval.
- FDA Deputy Commissioner Grace Graham said devices must enroll Medicare beneficiaries in an Investigational Device Exemption (IDE) study and meet outcomes.
- CMS paused the TCET program for new candidates and estimates 40 devices qualify now, with 20 more possible.
