Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied DNA, Medalliance.
The FDA’s weekly town hall on testing for the COVID-19 pandemic included the usual range of concerns about test performance, but concerns regarding swabs and sample sites continue to mount. The predicament has led to the announcement that the FDA along with the National Institutes of Health (NIH) will hold a May 15 town hall regarding swabs, with a particular interest in swabs produced via additive manufacturing.
The U.S. FDA has given the greenlight to Eko Devices Inc.’s electrocardiogram (ECG)-based algorithm to aid in detecting patients with heart failure during the COVID-19 pandemic. The artificial intelligence (AI)-powered algorithm, which provides a quick way to screen for low ejection fraction, won FDA breakthrough status in December of 2019.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including the American Clinical Laboratory Association.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Critical Alert, Eko, Novocure, Optina Diagnostics, Zai Lab.
Abbott Laboratories received FDA emergency use authorization (EUA) for its COVID-19 molecular test, which will run on the company's new Alinity m system, as well as its COVID-19 antibody blood test, which will run on the Alinity i system. The two actions bring to five the number of COVID-19 tests developed by the Abbott Park, Ill.-based company to receive EUAs.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Applied Medical Resources, Cook Medical, GT Medical Technologies.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Caption Health, Cardiofocus, Cytosorbents, Helius Medical Technologies, Optiscan Biomedical, Ortho Clinical Diagnostics, Thermo Fisher Scientific, Transit Scientific.
The U.S. FDA has issued an emergency use authorization (EUA) for an antigen test for the SARS-CoV-2 virus from Quidel Corp., of San Diego, that is more readily deployed than other diagnostic tests for the pathogen. Quidel’s offering can be used at the point of care (POC) and as a lab test.
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