Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Check-Cap, Fujifilm, Olympus Medical, Pelican Diagnostics.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agendia, Hemex Health, Masimo, Painteq, Strata Skin Sciences, Wellframe.
Keeping you up to date on recent developments in cardiology, including: Lack of ‘moral compass’ cited as driver of increase in atherectomy in PVI; Study links hypertension to atrial fibrillation; Machine learning of limited value in predicting in-hospital AMI death.
Neuroclear Technologies Inc., a subsidiary of Biosig Technologies Inc. formed to focus on the emerging field of bioelectronics, was allowed a utility patent by the U.S. Patent Office that the company exclusively licensed from Mayo Foundation for Medical Education and Research. Neuroclear aims to use neurostimulation technology to develop novel solutions to challenging physiological and neurological disorders. The company's first target and the focus of the patent is treatment of hypertension via electroporation of renal nerves.
According to the latest annual overview published by trade association France Biotech, French med-tech, biotech, and e-health companies have adapted rapidly to the COVID-19 pandemic. Many French health care companies have faced real difficulties in all areas of procurement, R&D, and sales. As of February, a quarter of these French companies were redirecting their research activity towards the coronavirus.
Corvista Health Inc., a subsidiary of Toronto-based Analytics for Life Inc., reported closing on $65 million in series C equity financing, bringing total cash raised for a new cardiac diagnostics device to nearly $100 million. The Corvista system is described as noninvasive, point-of-care diagnostic system for coronary artery and other cardiovascular diseases.
Most of the med-tech companies doing business during the COVID-19 pandemic are experienced and already have their FDA compliance systems in place. However, Dennis Gucciardo, a partner at the D.C. office of Morgan, Lewis & Bockius LLP, told BioWorld that while the FDA will give industry sufficient time to transition their emergency use authorizations (EUAs) to conventional premarket filings, the cost of setting up a quality management system may be greater than some current EUA holders are willing to bear.
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