AI-Stroke SAS is developing an artificial intelligence (AI)-based application able to detect strokes in real time using a simple smartphone or a tablet. The med-tech firm has just won an award in the i-Lab 2023 innovation competition, supported by the French Ministry of Research and sovereign bank Bpifrance SA. “We use the latest AI and computer vision technology to replicate a neurologist’s expertise immediately anywhere, whereas non-specialists can make diagnostic errors up to 50% of the time,” Cédric Javault, CEO and co-founder of AI-Stroke SAS, told BioWorld.
Four months after raising $55 million, Magenta Medical Ltd. reported the completion of enrollment to a U.S. FDA-approved early feasibility study with the Elevate percutaneous left ventricular assist device (pLVAD).
Medalliance SA reported completion of patient enrollment in the SAVE clinical trial with its Selution SLR 018 drug-eluting balloon. Eighty-four subjects have been recruited for this prospective multi-center, single-blinded, randomized controlled trial. These patients received either standard high-pressure balloon angioplasty followed by local application of Selution SLR, or else high-pressure balloon angioplasty with no further lesion treatment.
Cochlear Ltd. and Sensorion SA have published encouraging results on the combination of a molecule with a cochlear implant. Their proof-of-concept phase 2a study involved the combination of an orphan drug recognized in both Europe and the U.S. with cutting edge hearing aid implants to enhance the auditory capabilities of hearing aid users.
Cochlear Ltd. and Sensorion SA have published encouraging results on the combination of a molecule with a cochlear implant. Their proof-of-concept phase 2a study involved the combination of an orphan drug recognized in both Europe and the U.S. with cutting edge hearing aid implants to enhance the auditory capabilities of hearing aid users.
The French National Insurance Fund, known as La Caisse Nationale d’Assurance Maladie, a division reporting to the Ministry of Health and the Ministry of Economics and Finance in France, has released its annual report containing proposals aimed at achieving financial balance in the nation’s health insurance expenditures. The 100-page document will be submitted to the parliament to be voted upon this fall. “These are precise, concrete recommendations drawn up after an in-depth analysis of trends in expenditure and practices,” said Thomas Fatôme, general director of the National Insurance Fund.
The European Commission’s (EC’s) Directorate-General for Health and Food Safety recently published a survey of notified bodies. This was conducted between April and May 2023, eliciting responses from all 39 notified bodies designated under the Medical Devices Regulation (MDR) and 10 Notified bodies designated under the In Vitro Diagnostic Regulation (IVDR).
Safe Orthopaedics SAS reported results from a biomechanical study comparing its new surgical technique Sycamore – a pedicle-anchored implant – with standalone balloon kyphoplasty. The results published in summer 2023 in the Journal of Experimental Orthopaedics showed a “significant increase” in compression strength with patients using Sycamore.
Tandem Diabetes Care Inc. obtained reimbursement in France for its Control-IQ technology, an advanced hybrid closed loop system for patients with type 1 diabetes that uses an algorithm to automatically adjust insulin in response to predicted glucose levels.
Fractus SA reported that it has successfully transferred its wireless implantable device technology to improve the way doctors monitor patients remotely, thereby boosting the adoption of implantable health care services by leveraging wireless connectivity.
