LONDON – The U.K.’s influential health technology assessment body, the National Institute of Health and Care Excellence (NICE), is consulting stakeholders on proposed changes to how it selects medical devices, diagnostics and drugs for evaluation.
Royal Philips NV is reporting the launch of Philips Ventilator Bipap A40 EFL, a noninvasive ventilator that aims to help patients with chronic obstructive pulmonary disease (COPD) breathe easier. With its CE mark in hand, the company has tagged initial target markets as France, Italy and the U.K. Additional European markets are expected to come next year.
PARIS – Fineheart SA has announced the success of a 30-day preclinical trial to evaluate its implantable cardiac output management system (ICOMS) for patients suffering from severe heart failure. The device was well-tolerated with no related adverse events seen during the 30 days.
PARIS – At the recent annual HealthTech Innovations Days in Paris, the European investment Fund (EIF) and the world’s largest life sciences consortium, EIT Health Germany, reported the development of a Venture Centre of Excellence (VCoE) in Europe.
LONDON – Three large scale population surveys conducted between late June and the end of September have shown the prevalence of SARS-CoV-2 antibodies in England declined by 26.5% over three months. The findings rest on the results of more than 350,000 self-administered lateral flow blood tests that were carried out at home by volunteers who were randomly selected from general practitioner registers.
PARIS – Carthera SAS, of Paris, has obtained a $2.4 million grant and $12.5 million equity investment from the European Innovation Council (EIC) for the development of its ultrasound-based medical device for treating glioblastoma.
Royal Philips NV is launching its Quickclear mechanical thrombectomy system in the U.S. four months after obtaining FDA clearance. “Quickclear's intuitive design simplifies the entire thrombectomy procedure work flow. Our new medical device can help bring cost-effective solutions in both the hospital and outpatient care settings,” Chris Landon, senior vice president & business leader, image guided therapy devices at Philips, told BioWorld.
Endologix LLC has begun a controlled launch of its Alto abdominal stent graft in Europe, following the receipt of CE mark approval in August. The next-generation Ovation system for polymer endovascular aneurysm repair (EVAR) is designed to provide the broadest indications in infrarenal EVAR grafts, including a 7 mm aortic neck length indication.
Fractional flow reserve (FFR) processing of computed tomography (CT) images has gained a substantial body of momentum over the past few years, but a recent study posed the question of whether it can save health care systems from excess spending for stable angina.
Medtronic plc management put an emphasis on being nimble and commercializing novel technology at its investor day this week, and analysts appeared to approve of the message. As Wells Fargo’s Larry Biegelsen noted, Dublin-based Medtronic is moving away from a centralized company that is focused on economic value and margin expansion to one that is more decentralized, emphasizing innovation and topline growth.