The FDA issued a June 10 warning letter to Innova Medical Group Inc. in connection with the company’s rapid antigen tests for the SARS-CoV-2 virus, an action that accompanies a class I recall and a safety communication.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Caldwell Industries, CM Life Sciences, Dexcom, Encore, Ensodata, Fresenius Medical Care, Humacyte, Integra Molecular, Predictmedix, Sema4, Shockwave Medical, Sientra, Vivante Health.
Researchers at the University of Washington reported in the May 31, 2021, issue of Nature Medicine that artificial intelligence (AI) algorithms meant to recognize COVID-19 infections based on chest X-rays picked up on confounders, selecting “shortcuts” such as patient age or positioning in the X-ray as a basis for their predictions.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3M, Advanced Human Imaging, Arya III, Autolomous, Avantor, Bio-Techne, C2i, Echonous, Eko, Fittrack, Gynesonics, Inqb8, Intervenn, Nautilus Biotechnology, New England Biolabs, Novogeneait, Paxman Coolers, Peijia, Portal Bioscience, Ritter, Trxade Health, Veranome Biosystems.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Able Medical Devices, Canon Medical Systems, Caremax Medical Group, Cathx Medical, Dedalus Group, Deerfield Healthcare Technology Acquisitions, Global Access Diagnostics, IMC Medical Group Holdings, Kumocare, Livful, Medline, Neupath Health, Obviohealth, Sofinnova Partners, Spectramed, Syntheticmr, Visionquest Biomedical, Zeus Industrial Products.
HONG KONG – Singapore authorities have given provisional approval for a locally developed breath test for COVID-19. The test is developed by Breathonix Pte Ltd., a spin-off company from the National University of Singapore through its Graduate Research Innovation Program. The company said its Brefence Go COVID-19 breath test system was the first test of its kind to secure provisional authorization in Singapore.