Clew Medical Ltd., of Netanya, Israel, has secured an emergency use authorization (EUA) from the U.S. FDA for its ClewICU system for use with COVID-19 patients in intensive care units (ICUs). The screening system is a standalone software as a medical device product that uses vital signs, laboratory data, medications and other information to assess the likelihood a patient has been infected with SARS-CoV-2, the virus that causes COVID-19.

The U.S. FDA finally granted Abbott Laboratories' Freestyle Libre 2 clearance as an integrated continuous glucose monitor (iCGM) for adults and children age 4 and older with diabetes. Abbott received CE mark for the device more than 18 months ago and discussed its submission to the FDA in an earnings call over a year ago. Abbott expects the device to be available at pharmacies and durable medical equipment suppliers within weeks.

The latest FDA report card on the quality of drugs being sold in the U.S. is nothing to brag about. On a grading scale where 90% to 100% is an “A” and anything below 60% is failing, the average manufacturing site inspection score for drugs marketed in the U.S. in fiscal 2019 would be a solid “C” – or 7.4 on the FDA’s 10-point grading scale. But at least 10 sites had failing marks with scores of 5.