Sudden cardiac arrest (SCA) kills millions of people worldwide each year, triggered by an electrical malfunction in the heart that causes it to unexpectedly stop beating, often without warning. Health care startup Transformative AI Ltd. wants to reduce those deaths. To that end, the company has secured $1.7 million in seed funding for artificial intelligence (AI)-driven software that predicts a patient’s risk of suffering SCA based on subtle physiological changes. Read More
The U.S. FDA has rewritten the emergency use authorization (EUA) for the Laboratory Corp. of America Holdings Inc. (Labcorp) COVID-19 polymerase chain reaction (PCR) test to allow for diagnostic testing of those who are asymptomatic and those who have no reason to suspect they are infected with the SARS-CoV-2 virus. Read More
HONG KONG – Chugai Pharmaceutical Co. Ltd. is hoping to start phase I trials for an as-yet-unnamed digital solution for measuring pain levels in endometriosis patients that it is co-developing with Biofourmis Inc. Read More
A medical device company has partnered with a couple of investment firms to tap new technologies and help bring them back to China. Venus Medtech (Hangzhou) Inc. formed a health care investment platform, Ascendum Capital Partners, to invest in new medical devices and technologies around the world, particularly in the cardiovascular and lung disease spaces. Read More
PARIS – Therapixel SA, of Nice, France, has obtained 510(k) clearance from the U.S. FDA for its Mammoscreen technology, a software platform based on artificial intelligence (AI) and used by radiologists for reading screening mammograms. “Obtaining FDA clearance is the result of working with radiologists over the past three years in order to develop a powerful tool providing relevant assistance in their day-to-day work,” Matthieu Leclerc-Chalvet, CEO of Therapixel, told BioWorld. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Atox, Bruker, Cell and Gene Therapy Catapult, Cpi, Healthimation, Masimo, Microfluidx, Nanthealth, Nemaura, OpenNMS, Orcam, Perimeter Medical Imaging, Telix Japan, Transenterix, Wishbone Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Color, Labcorp, Rapid Medical, Stratus Medical, Zebra Medical. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Fortress Diagnostics, Lemaitre Vascular, MedPAC. Read More
Keeping you up to date on recent developments in cardiology, including: Genetic testing for heart diseases could help identify risks; New option for monitoring heart health; Scorpions eyed for heart attacks. Read More
