PERTH, Australia – The British Standards Institute (BSI) granted Sydney-based Oncosil Medical Ltd. European CE marking approval for its brachytherapy device to treat locally advanced pancreatic cancer in combination with chemotherapy, clearing the way for marketing in both the EU and the U.K. BSI also granted the Oncosil device breakthrough therapy designation.

Charleston, S.C.-based startup ABM Respiratory Care has received U.S. FDA clearance for its first product, an airway clearance system known as Biwaze Cough. The portable device helps to remove secretions for people who are unable to cough or clear away secretions effectively on their own due to injury or disease.

Erlangen, Germany-based Siemens Healthineers AG has secured U.S. FDA clearance for its Rapidpoint 500e blood gas analyzer. Available in CE mark countries since August 2019, the device is used to monitor respiratory distress in critically ill patients, such as those in acute care due to COVID-19.

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.