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.
PERTH, Australia – On the heels of an AU$5 million ($US3.47 million) capital raise, digital health company Respiri Ltd. is preparing to launch its digital wheezo asthma measurement device in Australia as it transforms itself from a device manufacturer to an eHealth software as a service company (SaaS). Melbourne-based Respiri received its first batch of 500 wheezo devices in March, and the company plans to deploy them in Australia this quarter.
Check-Cap Ltd., of Isfiya, Israel, reported positive results from a U.S. pilot study of its C-Scan System, a preparation-free, ingestible scanning capsule-based technology aimed at preventing colorectal cancer (CRC) through early detection of precancerous polyps. The company is currently preparing an IDE submission with the U.S. FDA and plans to launch a pivotal clinical trial in late 2020.
LONDON – Monitoring low-density lipoprotein cholesterol (LDL-C) levels in patients with coronary heart disease (CHD) fails to identify those who are at highest risk for heart attack or death, according to a new study that used alternative biomarkers to assess the risk of further events.
PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny.
Patent holders are wasting their resources when they ask the U.S. Court of Appeals for the Federal Circuit for an en banc rehearing on diagnostic claims that have been declared ineligible because they cite a law of nature.
HONG KONG – To improve public health care in Brazil, Bioneer Corp., a South Korean biotech, and Brazilian government-run Institute of Technology on Imunobiologicals (Bio-Manguinhos) will focus on business development and R&D of in vitro diagnostics and new drugs.