April 23, 2026
RAPID Device Coverage: Rebrand or Brand New?
The joint CMS / FDA press release this morning outlining the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway for breakthrough medical devices strikes us more as a rebranding of the existing transitional…
July 23, 2025
Guardant Health (GH) Reveal Rate Expectations
We view CMS’s clinical laboratory advisory panel today as an incremental positive for Guardant Health (GH), despite what appears to be a lack of endorsement for the company’s request that payments for Reveal (0569U: $1,644)…