Medtronic plc got a thumbs up from the FDA for two Accurhythm algorithms to detect atrial fibrillation and asystole in patients who have heart rhythm abnormalities. The new artificial intelligence (AI)-based algorithms are designed for use on the company’s Linq II insertable cardiac monitor (ICM). Dublin-based Medtronic said the Accurhythm AI algorithms will be available on its Carelink Network later this year for use with all implanted Linq II devices in the U.S. Read More
Polarityte Inc.’s Skinte product met primary and secondary endpoints in a randomized clinical trial evaluating healing of diabetic foot ulcers. Skinte is a human cellular and tissue-based product made from a patient’s own skin. Results from the trial and data from the product’s use from 2017 to 2021 during a period of enforcement discretion by the FDA were used by the company in its filing earlier this week of an investigational new drug application for Skinte. Read More
PERTH, Australia – After raising A$10 million (US$7.36 million) in its initial public offering on the Australian Securities Exchange, BCAL Diagnostics Ltd. is racing to commercialize its noninvasive, blood-based in vitro diagnostic to detect breast cancer. The Breast Cancer Associated Lipids (BCAL) test is taken via a blood sample and analyzed for lipid biomarkers. Read More
Rsip Vision Ltd. has maintained its momentum with a couple of new software module releases, one focused on sports medicine and another for robotic assisted surgery. The most recent release is a software module that enables deep learning-based segmentation of joint cartilage from MRI scans of hips, knees and ankles. “It's about using AI-based auto segmentation to provide clinically valuable measurements,” Moshe Safran, the CEO of Rsip Vision U.S., told BioWorld. Read More
PARIS – French sovereign bank Bpifrance SA, the Digital Health Agency (ANS) and Impact Healthcare SAS have just published results from the first survey on progress being made by digital health startups in France. The survey, with financial support from Astrazeneca plc from the U.K. and French law firm Delsol Avocats Selarl, was carried out among roughly 100 founders of digital health startups in France. It reveals a lot of information relating to the progress made by digital health projects 18 months following the outbreak of the COVID-19 pandemic. “It is a matter of recognizing there are barriers to the French market even though e-health products and services are booming following the COVID-19 crisis,” Jean-Yves Robin, managing director of Impact Healthcare and co-author of the study, told BioWorld. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Affera, Balt, Guided Therapeutics, Mediwound, Natera, Positrigo, Veracyte. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3a-diagnostics, 903 Devices, 10x Genomics, Amwell, Angelmed, Armor Bionics, Bio-Rad, Blockmd, Carlsmed, Converse Health, Edgility, Exthera Medical, Fresenius Medical Care, Informed Data Systems, Levitee, NAMSA, NTT Research, Olympus, One Drop, Paragon, PCORI, Pear Therapeutics, Shapeways, Silvercloud Health, Still Technologies, Withings, Xphyto. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Asensus Surgical, Medtronic, Promega, Synchron, Voxneuro. Read More
