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. Read More
A green light from the U.S. FDA has significantly brightened Seno Medical Instruments Inc.’s image of its immediate future. The San Antonio-based company developed a novel breast cancer imaging technology that combines noninvasive opto-acoustic (OA) technology with ultrasound (US) to more accurately distinguish benign from malignant breast lesions following ambiguous mammography results. Read More
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. Read More
When it comes to leveling the playing field for foreign-based biopharma and medical device companies, China has made a lot of promises, but delivering on those promises is what matters. Throughout its annual assessment for Congress of China’s commitment to World Trade Organization principles, the U.S. Trade Representative (USTR) noted the many promises China has made over the years that have yet to be kept. Read More
In what is claimed as the first co-authored research between regulatory scientists at the U.S. FDA and a commercial manufacturer of organ-on-a-chip devices, CN Bio's Physiomimix system is shown to perform better than the current standard in vitro liver toxicity tests. In addition to maintaining its function for longer than 2D hepatocyte cultures or 3D spheroids, Physiomimix was found to reproducibly assess toxicity, metabolism and intracellular accumulation of drugs. Read More
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. Read More
New hires and promotions in the med-tech industry, including: Applied DNA, Cellanyx, Circulogene, HTG Molecular Diagnostics, Inspire Medical, Nano-X Imaging, Parcelshield, Truveris. Read More
Med-tech firms raising money in public or private financings, including: Elcam Medical, Innodem Neurosciences, Neurent Medical, Serenno Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lightpoint Medical, Omniguide Holdings, Renegade.bio. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS, OIG differ on CERT program. Read More
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. Read More
