EBR Systems, Inc., based in Sunnyvale, California, has announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has commenced a National Coverage Determination (NCD) for its WiSE System, a leadless left ventricular endocardial pacing (LVEP) technology aimed at treating heart failure. This decision follows EBR's engagement with CMS through the Transitional Coverage for Emerging Technologies (TCET) pathway, which is designed to expedite Medicare coverage for innovative devices. The WiSE System is the first technology to enter this program, highlighting its clinical significance. CMS's timeline suggests that a positive NCD decision could be made by early 2027, a notable acceleration compared to the usual three to five-year process. If approved, the NCD would provide a uniform coverage framework, significantly increasing patient access and supporting commercialization in the U.S. The WiSE System, which utilizes ultrasound for pacing without a transvenous lead, has already received FDA approval and Breakthrough Device designation, further paving the way for its integration into Medicare coverage. Until the NCD is finalized, the system will be evaluated individually based on medical necessity for Medicare beneficiaries.