Latest Medicare Coverage News

Pacific Edge reported a $35.8 million loss in FY26 amid a 47% revenue drop following Medicare coverage loss, but a draft Medicare policy and $36.1 million capital raise set the stage for recovery.

EBR Systems has secured a significant regulatory milestone as the US Centers for Medicare & Medicaid Services (CMS) initiates a National Coverage Determination (NCD) for its WiSE wireless cardiac pacing system, aiming for approval by early 2027.

Control Bionics advances its neural-signal technology across assistive communication, sports, and medical sectors, securing key US reimbursement and distribution agreements while broadening its international footprint.

Pacific Edge reported a steep 47% revenue drop in FY26 following Medicare coverage loss but secured a draft Medicare policy covering its Cxbladder tests and raised NZ$25.4 million to fuel growth and commercial execution.

Pacific Edge edges closer to a Medicare breakthrough with a draft Local Coverage Determination proposing coverage for its Cxbladder Triage and Triage Plus tests, potentially unlocking reimbursement for over 66 million US patients.

Pacific Edge launches a NZ$6 million retail share offer at NZ$0.17 per share following a NZ$25.4 million institutional placement, aiming to strengthen its balance sheet and support Medicare reimbursement efforts for its bladder cancer diagnostics.

Anteris Technologies reported a $22.9 million net loss in Q1 2026 but bolstered its cash position to $283 million following a $320 million capital raise. The company is scaling manufacturing and clinical activities for its DurAVR transcatheter heart valve, with US patient enrolment now underway in the pivotal PARADIGM Trial.

Pacific Edge has raised NZ$25.4 million through an oversubscribed placement priced at NZ$0.17 per share, aiming to bolster operations, support Medicare re-coverage efforts, and advance its bladder cancer diagnostic tests.

Pacific Edge is raising NZ$24 million to shore up its finances and support a crucial Medicare re-coverage bid following a steep revenue drop after losing Medicare reimbursement for its bladder cancer test. The company eyes a draft Medicare policy by September 2026 as a potential turning point.

Anteris Technologies has gained U.S. Medicare reimbursement eligibility for its pivotal PARADIGM Trial, clearing a key hurdle for clinical site activation and accelerating its transcatheter heart valve study.

Pacific Edge reported a 2.7% increase in test volumes for Q4 2026 despite operational challenges, supported by growing momentum toward Medicare coverage and expanded commercial payer adoption in the US and Asia Pacific.

A recent expert panel convened by Novitas has strongly endorsed Pacific Edge’s urine-based Cxbladder tests for hematuria evaluation, recommending Medicare coverage based on robust clinical evidence and patient care benefits.