TORONTO – The Government of Canada is fast tracking importation of two U.S. manufactured test kits for COVID-19, issuing an interim order for sale of the Cobas SARS-CoV-2 diagnostic test kit developed by Pleasanton, Calif.-based Roche Molecular Systems Inc. and Waltham, Mass.-based Thermo Fisher Scientific Inc.’s Taqpath COVID-19 Combo Kit.

Pear Therapeutics Inc. obtained FDA approval for Somryst, the first prescription digital therapeutic for chronic insomnia. The app provides structured cognitive behavior therapy (CBT) with clinical dashboards for physicians. While CBT is the recommended first-line therapy for insomnia, the U.S. has only 500 therapists certified to provide CBT for insomnia (CBTi) for the estimated 30 million Americans who suffer from chronic difficulty going to and staying asleep.

LONDON – The European Commission (EU) is pulling the plug on implementation of the Medical Devices Directive (MDR) on May 26, to free up resources and expertise as countries across Europe struggle to deal with the COVID-19 crisis.

BOGOTA, Colombia – The global shortage of ventilators caused by COVID-19 is not news to the Latin American region, an area already preparing for the tsunami of patients that could flood hospitals as it has done elsewhere. The region is trying to learn from the mistakes made by European countries before it is too late.

Aegea Medical Inc., of Menlo Park, Calif., has received U.S. FDA approval for its next-generation Mara water vapor ablation system, the only endometrial ablation treatment that uses vapor to treat heavy menstrual bleeding. The first commercial procedure was performed by Kirk Brody, an obstetrician-gynecologist in Chattanooga, Tenn.

The surge of interest in testing for the COVID-19 pathogen has led to some innovative tests and test strategies, including at-home tests. However, the FDA has indicated that it is wary of both at-home testing and specimen collection in other than supervised settings, a policy that is meeting with criticism from some quarters, but not all.