Given all the public-private partnerships responding to the need for timely COVID-19 therapies, diagnostics and vaccines, the demands to forgo patents or exclusive licenses for coronavirus products and the clamor that industry shouldn’t “profit” from U.S. taxpayer-supported research are growing louder.
Siemens Healthineers AG expects to have a total antibody test available in late May 2020 to identify individuals exposed to the SARS-CoV-2 virus that causes COVID-19. The rapid diagnostic test detects IgM as well as IgG and other antibodies in the blood.
Pittsburgh-based Alung Technologies Inc. has received emergency use authorization from the U.S. FDA for its Hemolung Respiratory Assist System (RAS) to treat lung failure caused by COVID-19. The technology could help to ease demand for ventilators, which have been in short supply in coronavirus hot spots, and provide an alternative for patients who can’t tolerate mechanical ventilation.
Vayyar Imaging Ltd., which focuses on 4D radar imaging, reported that the Israeli government is using its sensor technology to fight the spread of COVID-19. “Vayyar uses 3D imaging to map what is happening in any environment but incorporates a fourth dimension – detecting and analyzing changes over time – to provide the most comprehensive monitoring solution,” Ofer Familier, general manager of Vayyar, told BioWorld.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Vela Diagnostics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied Biocode, Assure Holdings, Cylera, Doctor On Demand, Evanston Technology Partners, Micron Solutions, Nexstim, Readcube, Royal Philips, Tauriga Sciences, Thermo Fisher Scientific, Vizient.
The U.S. Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) said that they will offer enforcement discretion for their respective final rules for electronic health records (EHRs), a nod to the COVID-19 pandemic. The term of the delays of compliance for several of these rules is not uniform, ranging from “late 2020” to “spring 2021,” and vendors thus will have to be vigilant to ensure they do not cross any compliance tripwires.
Oxford, U.K.-based Perspectum Diagnostics Ltd. is recruiting patients for a study to determine the degree of damage sustained by major organs following infection with the SARS-CoV-2 virus. The company will use its multiparametric magnetic resonance imaging (MRI) devices and other means to evaluate post-COVID-19 organ damage, track healing and evaluate impact on survivors.
Cytovale Inc., a San Francisco-based medical technology company, has snagged an additional $3.83 million in funding from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) to conduct a pilot study of its Rapid Sepsis Diagnostic System for patients with potential respiratory infections, including SARS-CoV-2, the novel coronavirus responsible for COVID-19. The patented technology, which can diagnose sepsis in less than 10 minutes, could speed up triaging and treatment of critically ill patients suspected of having the life-threatening condition.