The U.S. Centers for Medicare & Medicaid Services (CMS) issued a final version of a proposed rewrite of the national coverage determination (NCD) for mitral valve repair devices that includes a coverage with evidence development (CED) mandate. The final also retains the draft’s provisions for secondary mitral valve regurgitation, which analysts say will double or even triple the market for devices thus approved by the FDA.
PARIS – France’s Comité Economique des Produits de Santé (CEPS), which reports to the Ministry of Health, has released its latest financial figures for medical device reimbursement. Health insurance expenditures amounted to $11.6 billion during the last full financial year reported by CEPS, representing annual growth of 4.66%. Over the last two years, more than half of expenditures have focused on four therapy areas: orthopedics, pulmonology/ENT, cardiac and vascular systems, and diabetes.
Haemonetics Corp. said Wednesday that it will acquire Cardiva Medical Inc., a privately held manufacturer of blood closure systems, for up to $510 million. The all-cash deal expands Haemonetics’ hospital portfolio with two catheter-based devices used to shut off access sites following minimally invasive cardiology and electrophysiology (EP) procedures.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lightpoint Medical, Omniguide Holdings, Renegade.bio.
Keeping you up to date on recent developments in orthopedics, including: New method heals skeletal injuries with synthetic bone; Designer cytokine makes paralyzed mice walk again; Osteoporosis drug could halve number of redo hip replacement operations.
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