The U.S. FDA has granted emergency use authorizations (EUAs) to Baxter International Inc. for its HF20 Set and ST Set used in continuous renal replacement therapy (CRRT) during the COVID-19 pandemic. The two sets are intended for use with the company’s Prismaflex or Prismax CRRT monitors. Read More
In a single draft coverage memo, the U.S. Centers for Medicare and Medicaid Services (CMS) proposed to eliminate national coverage for artificial hearts and to provide coverage of ventricular assist devices (VADs) coverage for those in need of short-term ventricular support. Coverage of artificial hearts would thus revert to Medicare administrative contractors, while the change in VAD coverage would resolve a long-running dispute between cardiologists and the agency. Read More
Clearcam Inc.'s Kelling device has an improved view of the market thanks to the closing of a $2.6 million series 2 seed financing round, led by investor and entrepreneur Frank Barbella, CEO of Solv Risk Solutions. Read More
While the U.S. and other countries are looking to step up their own domestic drug and device manufacturing, a bigger takeaway from the COVID-19 pandemic is the need for resilient supply chains that can withstand a global scramble for products suddenly more in demand than the supply can support. Read More
Much of the research on the immune response in patients with COVID-19 has focused on the humoral antibody response. Adaptive Biotechnologies Corp., on the other hand, has focused on cellular immunity to measure the T-cell response to infection with SARS-CoV-2. Read More
New hires and promotions in the med-tech industry, including: Bioventrix, Dexcom, Inteliquet, Kane Biotech, Portal Innovations, Wavefront Dynamics, Wishbone Medical. Read More
Med-tech firms raising money in public or private financings, including: Mobileodt, Neovasc, Reify Health, Pacific Biosciences of California, Personalis, Quanterix. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akoya Biosciences, Beroni Group, Biodesix, Biotricity, Caregility, Cdx Diagnostics, Celltrion, Dartmouth-Hitchcock Health, Datanet Software Development, Epic Systems, Genedx, Moleculight, Genscript Biotech, Health Catalyst, Imricor, Iron Bow Healthcare Solutions, Itoco, Monopar, Nexstim, Pediatrix, Sherlock Biosciences, Tabula Rasa, Vitalware. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baxter, Lantheus. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: American Medical Association, Bayer AG, Snomed International. Read More
Keeping you up to date on recent developments in orthopedics, including: Long-term risks of joint implants; New approach to treating osteoarthritis advances; Osmotic therapy device reduces swelling to prevent secondary injuries in rats. Read More
