United Kingdom
While the UK’s new plan to unlock public health data is a good start, complete, accessible data and regional computational infrastructure are needed to properly train AI for healthcare innovation, AI expert Muhammad Bilal tells Medtech Insight.
The long-awaited post market surveillance regulation for medical devices on the Great Britain market will come into force on 16 June.
Greater reliance on point-of-care testing ticks the patient-centricity box of UK’s proposed elective care reform. But quality oversight from pathology professionals is vital to ensure that the safety and reliability boxes are also ticked, says the Institute of Biomedical Science.
AI diagnostic biotech startup Owkin says AI adoption in digital pathology is slower than in radiology. In a new report, it identifies reimbursement structures and lack of funding and operational resources as barriers to faster adoption.
The UK government kicks off a big year for National Health Service reform with a plan for 17 new or expanded surgical hubs by June and greater reliance on Community Diagnostic Centres.
Scotland has a strong foundation of medtech research, but to reach the ‘tipping point’ where it has gained critical startup mass, it must overcome funding challenges and foster corporate startup partnerships.
The medtech sector in the UK, Switzerland, and Germany face a challenging 2025, heads of national trade groups say. Competition and access to innovation remain key concerns across the board, with collaboration with the EU and US planned in Switzerland while Germany focuses on approaching elections.
MHRA AI Airlock participant Lenus Health has secured three UK provider agreements for use of its COPD predictive AI risk stratification tool for use in the NHS.
UK MHRA updates timings for key elements of the new system of medtech regulation in Great Britain and prepares to assess IVD sector views.
Applications for the AI Airlock regulatory sandbox pilot phase closed in October. The selected technologies address hospital administrative load, earlier treatment intervention and real-time AI monitoring.
New tax on firms will leave less room for business growth, UK medtechs fear.
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.