The FDA reported Oct. 14 that software used with the Alinity m test kit by Abbott Laboratories is being recalled for the potential for false positive results, a problem due to software used to automate the processing of the test. This recall was originally issued in mid-September, but the Abbott Park, Ill.-based company is advising labs to treat any test result as presumptive at best.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Andau Medical, Detect, Ganymed Robotics, Milestone Scientific, New Al Farwaniya Surgicals and Medical Equipment, Pathai, Roche, Sanolabor.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Diagnostics Research Group, Diomics, Halleck-Willard, Icecure Medical, IMA Group, Integrated Media Technology, Magnum International, Nutriband, SPT Labtech, Steripack.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cytosorbents, Limflow, Medalliance, Todos Medical.
PERTH, Australia – Molecular diagnostic company Speedx Pty Ltd. has invested in a Perth-based startup that makes the raw materials needed for polymerase chain reaction (PCR) COVID-19 tests. The two companies will work to develop a new at-home rapid PCR test to ensure Australia can become self-sufficient with producing PCR tests. A rapid PCR test that gives an accurate result in minutes could be used at home or work.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Perkinelmer, Venclose.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aspira Women’s Health, Capnostics, Dariohealth, Genoox, Healthverity, Mynd Life Sciences, Neurometrix, Ondine Biomedical, Pavmed.
Advocates have continued to press for more widespread use of rapid antigen tests in the home as a primary instrument for returning to economic normalcy, and the FDA has granted an emergency use authorization (EUA) to Acon Laboratories Inc., of San Diego, for the company’s Flowflex rapid antigen test for at-home use. According to the FDA, Acon said the COVID-19 test will be produced at a rate of 200 million a month by February 2022, a clip that should go a long way toward restoring vigor to a lagging U.S. economy.
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