The pandemic-driven FDA guidance for device shortages addressed a topic that has been discussed for devices for some time despite lack of congressional action, but shortages may be ordinarily interpreted as a consequence of reduced or terminated production that crimps supplies. That interpretation has been expanded for the duration of the COVID-19 pandemic, however, to include circumstances in which demand exceeds supply even when the manufacturer sustains normal production levels, in which case the manufacturer is liable for reporting the shortage to the FDA.

Like many other med-tech companies, Medtronic plc, of Dublin, saw COVID-19 affect its financial results for its fourth quarter and fiscal year 2020, as procedures were deferred in the wake of the pandemic. Quarterly worldwide revenue came in at $5.998 billion, representing a decrease of 26% as reported and 25% on an organic basis.

Mammoth Biosciences Inc., of South San Francisco, and London-based Glaxosmithkline plc (GSK) have joined forces to develop a point-of-care test to detect active COVID-19 infections using Mammoth’s CRISPR-based DETECTR platform. The two companies hope to submit an application to the U.S. FDA for emergency use of the test before the end of the year.

HONG KONG – A researcher at Israel’s Ben-Gurion University of the Negev (BGU) has developed a test that identifies those carrying the COVID-19 virus in less than a minute. And it is both affordable and works with greater than 90% accuracy to boot.