New York-based Brain Scientific Inc., a neurology-focused medical device and software company, has entered an agreement with Europe’s leading certification and compliance company Afina s.r.o. The agreement specifies that Afina will act as an authorized representative for Brain Scientific in the EU and assist with registering Brain Scientific’s advanced EEG solutions in 32 countries in the European market. Brain Scientific’s disposable EEG devices are designed to address the growing need for neurological services globally.
Guangzhou, China-based Burning Rock Biotech Ltd. entered a development and commercialization agreement with Salt Lake City-based Myriad Genetics Inc., which will bring Mychoice tumor testing for homologous recombination deficiency to China. The test enables physicians to identify patients with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in potentially increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. Through the partnership with Myriad, Burning Rock will perform Mychoice HRD testing in China for collaborative drug development studies and for clinics.
Tewksbury, Mass.-based Corvia Medical Inc., a company dedicated to transforming the treatment of heart failure (HF), reported completion of randomization in its REDUCE LAP-HF II global, pivotal trial. The trial is evaluating the Corvia Atrial Shunt (IASD) to reduce elevated left atrial pressures, the primary cause of HF symptoms, in heart failure patients with preserved ejection fraction (HFpEF) or mid-range ejection fraction (HFmrEF). The company also reported authorization by the U.S. FDA to continue evaluation of the Corvia Atrial Shunt under a continued access protocol (CAP) while its pre-market approval (PMA) application is under review. PMA submission is planned for late 2021. The study randomized 626 patients at 109 sites across 15 countries, with the aim to improve quality of life, reduce HF symptoms and decrease HF-related hospitalizations. Primary outcome measures will be evaluated after the last randomized patient completes 12-month follow-up.
Lyon, France-based Edap Tms SA, a developer of robotic energy-based therapies, signed an exclusive distribution agreement with Ab Medica, a distributor of medical technologies across Italy.
Elitechgroup Mdx LLC, of Bothell, Wash., said it submitted the SARS-CoV-2 Plus Elite Mgb assay to the U.S. FDA for emergency use authorization. The assay is for the in vitro qualitative detection and differentiation of RNA from the SARS-CoV-2, influenza A/B and respiratory syncytial virus.
Healthy.io Ltd., which has a presence in Boston, London and Tel Aviv, Israel, is partnering with the National Kidney Foundation (NKF) to offer its home urine albumin-to-creatinine ratio test kit, free of charge, to people who find they are at risk for kidney disease via a one-minute quiz created by NKF as part of its "Are You the 33%?" public awareness campaign. The test kits help detect early signs of kidney disease, often before any symptoms are present.
Memphis, Tenn.-based In2bones Global Inc., a manufacturer of implants for the upper and lower extremities, said that its subsidiary, In2bones USA, has reached an exclusive agreement with Invibio Ltd., of Lancashire, U.K., to commence an R&D and manufacturing collaboration that will apply Invibio’s PEEK-Optima Ultra Reinforced carbon fiber technology to In2bones’ lower extremity implants.
Toledo, Ohio-based Infinity Angioplasty Balloon Co. said its Precision Angioplasty balloon platform – Infinity Angioplasty Balloon Catheter has completed its first-in-human clinical trial.
Stockholm-based Irras AB said that its Hummingbird family of intracranial pressure (ICP) monitoring equipment has been awarded a group purchasing agreement with Premier Inc., of Charlotte, N.C. Effective Dec. 1, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms prenegotiated by Premier for Hummingbird ICP Monitoring products.
Caesarea, Israel-based Itamar Medical Ltd. reported the preliminary results from two large claims database studies that demonstrated the health economic benefits of effective sleep apnea management for patients with chronic cardiovascular diseases. An analysis of both Medicare and commercial claims revealed that cardiovascular patients who were diagnosed and complied with treatment for sleep apnea generated material savings to the healthcare system compared with those who were not effectively treated. In addition, cardiovascular patients with sleep apnea who complied with continuous positive airway pressure treatment generated annual savings of approximately $5,000 per patient compared with those who did not comply.
New York-based Kohlberg Kravis Roberts & Co. LP and Duke Rohlen reported the formation of Zeus Health, a $100 million platform focused on investing in and operating a portfolio of emerging medical device companies.
Newton, Mass.-based Life Image reported the availability of Life Image Network Connector. It is the company’s latest interoperability solution, developed due to demand from smaller health care organizations to digitally exchange medical images and other health data with the company’s network of large academic medical centers, specialty hospitals, research organizations and health systems.
Portland, Maine-based Medrhythms reported a partnership with the Roux Institute, also of Portland. The partnership will generate strategic research collaborations between the two organizations and provide co-op opportunities with Medrhythms to Roux Institute students.
Seattle-based Nanostring Technologies Inc. reported a collaboration with Oregon Health & Science University for the development of novel Geomx Digital Spatial Profiler protein assays to spatially profile breast cancer.
Boston-based Pear Therapeutics has released Somryst, the first U.S. FDA-authorized prescription digital therapeutic (PDT) for the treatment of chronic insomnia. The company is launching the product via an end-to-end virtual care experience combining virtual doctor visits with its PDT patient service center, Pearconnect.
Pharmajet Inc., of Golden, Colo., said its Tropis needle-free injection system will be used by San Diego-based Diomics Corp. to deliver a biopolymer to detect the formation of an immune response to a SARS-CoV-2 protein. The company was awarded more than $2 million by the U.S. Department of Defense to accelerate testing of its Diocheck system and is expected to begin clinical trials next month.
SyntheticMR AB, of Linköping, Sweden, said it has filed a 510(k) submission with the U.S. FDA for its quantitative SyMRI MSK musculoskeletal solutions package.
Sysmex America Inc., of Lincolnshire, Ill., is adding the Cellavision Dc-1 to its portfolio of Cellavision products for low-volume hematology labs. The product, which received U.S. FDA clearance last month, automates the process of performing blood cell differentials.
Chicago-based Tempus Labs Inc. and the Yale School of Public Health have teamed up to accelerate the development of COVID-19 diagnostic tests in the U.S. The partnership will further develop Salivadirect, a saliva-based laboratory diagnostic test developed by researchers at Yale, to enable home sample collection and to combine COVID-19 and influenza testing of saliva samples.
Marseille, France-based Vect-Horus SAS is collaborating with the European Centre for Research in Medical Imaging to support the preclinical development of Vect-Horus’ theragnostic agents. Vect-Horus is co-developing with Houston-based Radiomedix Inc. one agent that will enter clinical trials in 2021 for the diagnosis of glioblastoma.
Zebra Medical Vision Ltd., of Shefayim, Israel, is partnering with Tel Aviv-based Clalit Health Services, Israel’s largest mandated health service organization, to deploy cloud-based imaging artificial intelligence in a large-scale enterprise.
Zoll Medical Corp., of Chelmsford, Mass., and the U.S. Air Force Research Laboratory have signed a patent license agreement to make it easier for deployed medics to document vitals, help administer critical care, integrate patient data and identify the exact location of casualties in combat environments. The agreement reinforces the integration of Zoll’s Propaq patient monitors and monitor/defibrillators into the Battlefield Assisted Trauma Distributed Observation Kit, or BATDOK, a point-of-injury software tool.