The U.S. FDA has granted an emergency use authorization (EUA) to Cepheid Inc., of Sunnyvale, Calif., for a rapid molecular diagnostic to detect SARS-CoV-2, the virus that causes COVID-19. The Xpert Xpress SARS-CoV-2 test is designed for the qualitative detection of the novel coronavirus and runs on the company’s automated Genexpert systems, with a turnaround time of about 45 minutes. Read More
With an eye toward helping those potentially suffering from COVID-19, Mountain View, Calif.-based Alivecor Inc. said its six-lead electrocardiogram (ECG), known as the Kardiamobile 6L, now is allowed for use in the measurement of a patient's QTc and detection of QT prolongation. The Kardiamobile 6L enables patients to take a six-lead ECG outside a doctor’s office. Read More
Zurich-based startup Ava Science Inc. recently issued a public call for partners and funding to further research the potential usefulness of its fertility wearable, known as Ava Bracelet, during the COVID-19 pandemic. Read More
LONDON – COVID-19 excepted, biomedical research projects and clinical trials are grinding to a halt across Europe, as universities shut down and administrators stop any work not related to the coronavirus. Read More
Business as usual only three months ago has transformed into health care industry overdrive as biopharma and med-tech companies scramble to test and scale-up treatments, vaccines and diagnostics to address COVID-19. Read More
HONG KONG – Korean biopharma Celltrion Inc. said it’s halfway through the process of creating a super antibody to reign in the COVID-19 novel coronavirus that has claimed almost 13,000 lives globally. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Behold.ai, Biome Analytics, COVID-19 Healthcare Coalition, Harvard Bioscience, Masimo, Medical Alley Association, Mitre, Nxgen MDx, Novocyt, Parallax Health Sciences, Senseonics, Smiths Group, Thornhill Medical, Xphyto Therapeutics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alivecor, Arch Therapeutics, Canon Medical. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Arthrex Inc., Smith & Nephew Inc. Read More
Keeping you up to date on recent developments in cardiology, including: Hypertension-related deaths on the rise in the U.S.; Findings: Eating protein could ward off AF in women; Researchers: Assessing patients soon after stroke can help link brain regions, speech functions. Read More
