Implementing a reflex test alongside traditional prostate cancer screening is cost-effective for high-risk groups, claims Prostate Cancer Research UK. Oxford BioDynamics sheds light on UK market conditions influencing the adoption of its reflex test, EpiSwitch PSE.
EU industry advocates for amendment to existing proposal to streamline clinical strategy costs and timelines, as well as boost efficiency and innovation
Assimilated EU medtech law used in Great Britain will not be sunsetted on 26 May 2025, as originally provided for. That was the first decision published by the MHRA in the wake of its recent consultation on shaping the regulatory system.
As the EU AI Act takes shape, critical details are emerging rapidly. However, the approaching deadlines are even more pressing. This article delves into the essential information that medtech professionals need to stay ahead.
Germany’s government-industry healthcare industry roundtables have yielded a final report, even though the program was curtailed by the snap election. The new CDU-led government should pick up the baton, medtech industry associations say.
In this first of a two-part series highlighting digital and healthtech innovation in Barcelona, Medtech Insight visits the Barcelona Health Hub, a nonprofit that seeks to advance digital health innovation by bringing together start-ups, investors, health care institutions and corporations.
The EU’s new Product Liability Directive will make it easier for European consumers to seek compensation relating to defective products even if manufacturers are based outside the bloc. Legal experts caution that this could have substantial implications for pharmaceutical companies.
The Irish notified body has had to suspend IVD client work since late 2024.
Industry and healthcare professionals generally welcome the European Commission's proposal to broaden the use of eIFUs. However, more official statements are still awaited.
MELD Graph could help speed up the diagnosis and treatment of people with epilepsy by spotting "invisible" brain lesions often missed by radiologists. The new open-source AI tool developed by UK researchers could save the NHS up to $70,000 per patient, said researchers.
Germany’s center-right Union won the right on 23 February to head the governing coalition for the next four years, but the medtech industry’s first strong message is to ensure exports channels are not impeded by the imposition of US tariffs.
The digital health market includes thousands of app-based solutions targeting single health conditions, but the cost, complexity and number of options “gives too many opportunities to health care systems to say no,” said Mike Trenell, Daiser CEO. The second generation of digital health might have the answers, he said.
This brings the total number of notified bodies appointed under the IVDR to 14
As the EU seeks to refine its medtech regulations, the advantages of the global Medical Device Single Audit Program are increasingly highlighted. Industry leaders are now urging authorities to take decisive action.
Researchers from the National Institute for Health and Care Research (NIHR) Oxford Biomedical Research Center are testing Digostics’ GTT@home test in children to assess if it offers a better alternative to the clinical gold-standard oral glucose tolerance test.
The latest list includes a new EU document in the wings that addresses the designation of medtech notified bodies under the AI Act.
Boston Scientific has integrated cardiac mapping and pulsed field ablation into a single catheter with the newly EU-approved Farawave Nav Ablation Catheter. Faraview Software also receives CE marking, allowing for visualization of catheter placement when delivering therapy.
Medtechs watch with interest as NICE, a long-standing component of market access for innovative technologies in the National Health Service, vows to get to grips with technology programs that often miss the target for developers of groundbreaking solutions.
France-based Germitec aims to double its yearly revenue by expanding its UV-C disinfection technology for endocavitary ultrasound probes into the US market.
Volta Medical’s TAILORED-AF clinical trial demonstrates that AI can achieve "superior efficacy" in interventional cardiology. The study examined the use of AI-driven Volta AF-Xplorer in addition to pulmonary vein isolation in treating patient with persistent atrial fibrillation.