The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS unveils push toward digital collection of quality measures; NIH awards for ‘outside-the-box’ projects under RADx; ISO posts IP management standard.
Keeping you up to date on recent developments in cardiology, including: Differences seen between the sexes in terms of stroke survival; Light used to control cardiac waves; 3D-printed blood vessels ID possible link between coronavirus, stroke.
HONG KONG – A research team at the Chinese University of Hong Kong (CUHK) has developed a fully automated, low-cost and rapid microrobotic diagnostic system that can be used with multiple pathogens, including COVID-19. The system works by integrating fluorescent microrobots with an external magnetic actuation system to detect pathogens in patient samples.
Carmat SA said its total artificial heart received the CE mark, and the company plans to ramp up production to enable the launch of the device in the second quarter of 2021. The artificial heart offers a bridge to transplant in patients with end-stage biventricular heart failure. It provides an alternative for individuals for whom maximal medical therapy and left ventricular assist device are insufficient or contraindicated.
Clinical-stage oncology company Nuview Life Sciences Inc. is developing a cancer diagnostic test and treatment delivery system that could reduce the need for costly, less accurate tests and surgical biopsies. The binary – yes/no – test employs a proprietary peptide construct, NV-VPAC1, that targets a specific receptor, called vasoactive intestinal peptide receptor type 1 (VPAC1), that is overexpressed on the surface of cancer cells.
TORONTO – Waterloo, Ontario-based health startup Kenota Inc. has raised $9 million in series A funding to develop an in-clinic allergy test that takes less than 30 minutes and requires only a few drops of blood from a mild finger prick. This brings the total investment to $11 million for a point-of-care system that detects antibodies signaling allergies to egg, milk and peanuts and that will eventually search out environmental allergies to bee stings and shellfish.