Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diatherix, Medtronic, Photopharmics, Psychemedics, Senseonics, Vuno.
PARIS – Braintale SAS, of Paris, has gained CE mark approval for Brainquant. This software platform, which uses DICOM radiology imaging, enables diffusion MRI scans to be processed as part of managing patients in a coma following brain injury.
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.
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 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.
While many companies are looking to help monitor patients at home during the COVID-19 pandemic, 11 Health and Technologies Inc., of Irvine, Calif., is focused on those with chronic digestive diseases. The company recently said it was offering 12 weeks of free service using the Alfred Smartcare Platform to provide support for people with conditions such as inflammatory bowel disease, colorectal cancer and ostomies.
Paris-based health care startup Cardiologs Technologies SAS has launched a clinical study to assess the use of its artificial intelligence (AI) platform to remotely monitor cardiac safety in COVID-19 patients being treated with the malaria drug hydroxychloroquine. The study could help to detect and prevent serious cardiac effects of the drug.
PERTH, Australia – Cochlear Ltd., of Sydney, is gearing up to launch its new Remote Check solution for cochlear implant users on the heels of an AU$880 million (US$559 million) capital raise and a patent battle loss that it plans to appeal.
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