United Kingdom
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.
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.
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.
Oxford BioDynamics' blood-based colorectal cancer diagnostic test EpiSwitch NST has shown high accuracy (81-85%) and positive predictive values (57-87%) for colorectal cancer and polyps. By reducing false positives, the test could minimize unnecessary follow-up procedures.
The MHRA’s post-market surveillance regulations for Great Britain will be followed in 2026 by a pre-market regulation, but its progress will not be steered by the agency’s erstwhile leader of device system transformation. The ABHI’s Steve Lee and Phil Brown ponder where national device system regulation – and the MHRA – go next.
The US Food and Drug Administration (FDA) draft guidance limits tissue biopsy collection in clinical trials to primary endpoints and specific research use cases. However, Andrew Newland, CEO of circulating tumor cell (CTC) liquid biopsy firm Angle Plc, believes that the guidance could enhance the market for liquid biopsy makers.
The UK's established emergency care prehospital system potentially opens up a faster route to market for Front Line Medical Technologies's aortic occlusion device, COBRA-OS. Asha Parekh, Front Line CEO, talks to Medtech Insight about the company's different strategic approach to UK market access in comparison to North America.
Stock prices for liquid biopsy firm Angle Plc are up since 28 January after the release of new research. The study used Angle’s technology to detect clinically relevant mutations in circulating tumor cells that were not found in traditional circulating DNA, allowing for further insights into cancer progression, Andrew Newland, Angle CEO, told Medtech Insight.
Seven new Centers of Excellence for Regulatory Science and Innovation have been funded by the UK with a brief to investigate smart regulation of AI and digital health innovations, among other areas. Medtech Insight asked Alastair Denniston, leader of the CERSI in AI and Digital Health Technologies, to explain the significance and the goals of his center.
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.