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.
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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Asensus Surgical, Medtronic, Promega, Synchron, Voxneuro.
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.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Affera, Balt, Guided Therapeutics, Mediwound, Natera, Positrigo, Veracyte.
Access Biologicals LLC brought online newly released seroconversion panels that measure the level of antibodies against SARS-CoV-2 in blood samples, allowing researchers to determine vaccine efficacy. The panels can detect the point when seroconversion occurs and assess the efficacy of a vaccine against new and existing strains of the novel coronavirus. To build the panels, the Vista, Calif.-based company collected blood samples prior to vaccination and after the first and second doses. The plasma was then tested for IgG antibodies to the S1 and S2 spike proteins of the novel coronavirus using enzyme-linked immunosorbent assays (ELISA) and chemiluminescent assays (CLIA).
The FDA’s July 27 webinar on medical device servicing and remanufacturing lent some clarity to the terms of a recent draft guidance on the subject, but there are several overarching policy concerns. The FDA’s Joshua Silverstein said on the webinar that the agency sees servicing as a type of manufacturing, a view that is contradicted by the Medical Imaging & Technology Alliance, which indicated earlier this year that third-party servicers are probably not subject to the regulations applied to manufacturers.
Becton, Dickinson and Co. (BD) notched its sixth tuck-in buy of the year, acquiring long-time partner and resorbable polymer maker Tepha Inc. for an undisclosed sum. The deal will facilitate expansion of BD’s surgical mesh offerings and drive growth in new areas of soft tissue repair, reconstruction and regeneration. Wall Street gave the Tepha deal a thumbs up. After hitting a high of $256.32 Tuesday, BD shares (NYSE:BDX) maintained a strong beat, closing up 2.11 at $254.69.