Nutromics received FDA breakthrough device designation for its wearable patch designed to monitor vancomycin levels in real time. The monitoring approach targets a long-standing clinical challenge—therapeutic drug monitoring requirements that rely on periodic blood draws for a drug with a narrow management window. On the payer side, CMS issued final coverage changes for TAVR that expand Medicare coverage to patients with asymptomatic severe aortic stenosis. The decision is expected to support procedure volume growth and improve access under a broader clinical indication. Separately, Echo IQ disclosed a not substantially equivalent determination from the FDA for its AI heart failure diagnostic software, delaying U.S. commercial clearance for now—highlighting how regulatory outcomes for AI tools remain tied to evidence sufficiency. Overall, the cluster captures fast-moving reimbursement and clearance developments that could reshape how clinicians monitor therapy and diagnose cardiovascular disease.