Boston-based Abacus Insights, a data integration and interoperability platform that enables health plans and their providers to create a more personalized health care experience for consumers, said it has been certified by the Centers for Medicare and Medicaid Services (CMS) Qualified Entity Program. The company also reported the release of the Abacus CMS Interoperability Solution.
Becton, Dickinson and Co. (BD), of Franklin Lakes, N.J., reported a $24 million investment from the U.S. Department of Defense in collaboration with the U.S. Department of Health and Human Services to support the scale up of manufacturing capabilities for the BD Veritor Solution for rapid detection of SARS-CoV-2. The additional capital equipment will bolster domestic production and increase total production capacity by 50%. These investments will enable global production of more than 12 million test kits per month by the end of February 2021.
Biotelemetry Inc., a remote medical technology company based in Malvern, Pa., that is focused on the delivery of health information to improve quality of life and reduce cost of care, reported a sales agent agreement with Marlborough, Mass.-based Boston Scientific Corp. With this agreement, Biotelemetry becomes a sales agent in the U.S. for the Boston Scientific Lux-Dx insertable cardiac monitor system to an agreed upon subset of customers.
Blue Sail Medical Co. Ltd., of Zibo, China, opened its Blue Sail Shanghai Innovation Center at the Atlatl Innovation Center. Bluesail will have four product lines in the innovation center: coronary intervention products, structural heart products, peripheral vascular products and neurovascular products.
CHF Solutions Inc., of Eden Prairie, Minn., reported the signing of a distribution agreement with Hefa, Israel-based Systemedic Ltd. that covers Israel and Palestine, representing the second distribution partnership in the Middle East region.
Diazyme Laboratories Inc., an affiliate of General Atomics that is located in Poway, Calif., revealed a partnership with Maccura Biotechnology (USA) LLC for launching a SARS-CoV-2 RT-PCR diagnostics test. The latter’s parent, Maccura Biotechnology Co. Ltd., is in Chengdu, China.
Endologix Inc., of Irvine, Calif., reported the first commercial implant and the U.S. commercial release of its recently FDA-approved Alto endograft for the treatment of abdominal aortic aneurysms.
Eos Imaging SA, of Paris, reported that the first exams were performed with Eosedge in the U.S. at Gillette Children's Specialty Healthcare’s main campus located in St. Paul, Minn.
Irvine, Calif.-based Masimo Corp. said it has been selected by the National Basketball Association (NBA) as its official supplier of pulse oximetry. As teams return to play, Masimo will be supplying them with its Mightysat fingertip pulse oximeter on the NBA’s Orlando, Fla., campus.
Microoptx Inc., a Minneapolis-based company focused on treating glaucoma, has completed enrollment in the initial phase of its Beacon study, an U.S. FDA IDE trial to evaluate the Beacon Aqueous Microshunt. The initial phase of the interventional, single-arm, open label, multicenter study will form the basis of a larger trial to include 90 implanted eyes, with a primary outcome of intraocular pressure reduction.
Limacorporate SpA, of San Daniele Del Friuli, Italy, said it is the first Italian company to obtain the EU Quality Management system certificate under the new Medical Device Regulation. The orthopedic devices company obtained the certificate, which allows it to place custom-made implantable devices in the market, from Tüv Süd.
Millstone Medical Outsourcing reported the completion of construction on its new Fall River, Mass. headquarters facility expansion. The expansion includes 60,000 square feet of state-of-the-art warehouse and office space to expand capacity at the Fall River company headquarters to a total of 120,000 square feet of production space.
Qualigen Therapeutics Inc., of Carlsbad, Calif., has begun shipping its Fastpack SARS-CoV-2 diagnostic test for COVID-19 antibodies. The company said it has submitted the test to the U.S. FDA for emergency use authorization (EUA) and notified the agency earlier this month of its plans to commence sales while the EUA is pending.
San Francisco-based Savonix Inc. and Mitani Sangyo Co. Ltd., of Kanazawa, Japan, are teaming up to provide Savonix’s digital cognitive assessment to all Mitani Sangyo employees older than 40 years of age. The test is not mandatory, but will be highly encouraged, the companies said.
Sedia Biosciences Corp., a producer of rapid point-of-care diagnostics formerly based in Portland, Ore., has relocated its assay development and manufacturing facility in Beaverton, Ore. The new 27,000-square-foot, state-of-the-art facility enables immediate scale-up of both manufacturing and research capabilities.
Austin, Texas-based Tff Pharmaceuticals Inc., a company developing drugs based on its Thin Film Freezing technology platform, reported that the last patient was dosed in the multiple ascending dose portion of its phase I study of voriconazole inhalation powder for invasive pulmonary Aspergillosis.
Toronto-based Titan Medical Inc. said it has completed design enhancements to instruments compatible for use with its single-port robotic surgical system. The company resumed development of the instruments in June following the close of an $18 million direct offering.