HONG KONG – Dreamed Diabetes Ltd., of Petah Tikva, Israel, has received both FDA clearance and the CE mark for an insulin dosing decision support software based on artificial intelligence (AI).

Chronic bronchitis affects more than 9 million people in the U.S., but current treatments fail to address the overproduction of mucus. Gala Therapeutics Inc., of Menlo Park, Calif., is looking to change that.

PERTH, Australia – The Therapeutic Goods Administration (TGA) is seeking feedback on a proposal that to change Australia's medical device essential principles for safety and performance to more closely mirror the new EU Medical Device Regulation (EU MDR).

The FDA granted breakthrough device status to Prescient Metabiomics' Lifekit Prevent colorectal neoplasia test. Prescient Metabiomics is a subsidiary of Carlsbad, Calif.-based Prescient Medicine Holdings Inc.