United Kingdom
As the consultation period draws to a close for the UK’s new inclusion and diversity guidance, researchers and sponsors are being invited to participate in a pilot next year to submit a diversity plan as part of their clinical trial application.
This week, the US device center announced a pilot program to speed communications about high-risk recalls; Cardinal paid $3.9B for Advanced Diabetes Supply Group and GIA Alliance; a companion diagnostic for Merck lung cancer drug Tepmetko got FDA clearance; and more.
IMU Biosciences joins a UK consortium of 27 academic and industry partners to undertake “immunoprofiling” of 6,000 cancer patients to assess their response to treatment.
In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb talks about her interview with GE HealthCare’s chief AI officer Parminder Bhatia about his vision for AI in health care and other highlights from HLTH. Natasha Barrow discusses her interview with Owkin on the EU AI Act and highlights Click Therapeutics’ latest clinical results.
A step-wise process is needed to improve UK diagnostic services, says a report authored by the Institute of Biomedical Science and PA Consulting. There are implications for industry in its recommendations.
The Life Sciences Innovative Manufacturing Fund, set out in the UK budget last month, is live for applications. More UK medtechs would benefit if the cost threshold were scaled down, the industry argues.
The public alongside clinicians and industry experts is asked to submit ideas for reforming the NHS via a dedicated online platform ahead of the new NHS Plan in 2025.
The Design for Life roadmap will help medtech companies comply with the UK NHS’s Net Zero 2045 greenhouse gas emissions target. A dedicated medtech innovation center is mooted.
A new UK medtech survey sets out industry’s market access and regulatory concerns and makes clear where system users see the need for improvement. There are some grounds for optimism, but the MHRA’s planned rise in regulatory fees could undo some of the good work.
Artificial intelligence and digital in healthcare are among four key scientific development areas that will benefit from the support of the UK Regulatory Innovation Office, the launch of which was announced by the government on 8 October.
Innovation in life sciences and UK NHS adoption of technology are high on UK’s political agenda in the post-election period. Projects at the MedTech Directorate and NICE, and support from the Office for Life Sciences, are playing into a renewed sense of optimism.
No longer a watchdog, the UK MHRA wants to be seen as an enabling regulator, using new methodologies and data sources to bring device innovations safely into use, says agency chief executive June Raine.
The results from a trio of studies show that AI-powered digital stethoscopes are effective at identifying patients at elevated risk of experiencing heart attacks and other major cardiac adverse events, according to Eko Health, whose technology was used to screen the participants in the studies.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
The ISRCTN clinical trials registry has launched an improved dashboard to provide metrics that reveal how many studies are complying with key transparency requirements. Badges are in place for individual studies meeting the transparency criteria.
Those working in the medtech sector returned from their traditional August break to a growing sense that the EU is more collectively aligned about the need to improve the medtech regulations and soon.
The UK medical devices regulator has announced a consultation on a pre-market statutory instrument to be completed by the end of 2024.
Philip Morris described a scenario of being essentially blacklisted by the health care sector and its CDMO partners as it threw in the towel on its £1.1bn acquisition of UK inhalation specialist Vectura. It agreed to offload the firm at a fraction of the initial cost.
The NHS England and NICE “rules-based pathway” plan for medtech innovation adoption includes a proposed funding cap that could stymie its aims. Elsewhere, progress is reported on the MHRA’s AI Airlock and UK post-market surveillance.
UK-based Biocomposites will begin selling in the UK its next-generation osteoinductive bone graft substitute, NanoBone, which came with its acquisition of Artoss GmbH in June 2023. Meanwhile, the company has purchased remaining shares in the manufacturers of SYNICEM and Subiton antibiotic bone cements and preformed antibiotic-loaded spacers.