United Kingdom

Owlstone Medical Develops P.aeruginosa Breath Test For Cystic Fibrosis Patients

 

Cambridge, UK-based breath biopsy company Owlstone Medical will apply its volatile organic compound analysis platform in an attempt to develop a test for the identification and monitoring of pseudomonas aeruginosa in patients with cystic fibrosis.

Wired Health: Women Of Wearables Shares Market Outlook

 

Medtech Insight sat down with Anja Streicher, chief marketing officer at Women of Wearables, a global community offering events and education resources to support the femtech industry, to discuss trends in the women's wearables tech market, challenges and innovators pushing the boundaries.

Medtech Regulatory System, IDAP And CERSI Top UK MHRA Agenda In March Update

 
• By 

Britain’s medtech system progress, smarter ways of working at the agency and getting smarter AI and digital technologies into circulation for patients, were themes woven through the UK MHRA board’s 18 March meeting.

Wired Health: One-Size-Fits-All Wearables Don’t Work For Women’s Health

 

Wearable technology must address women’s unique needs, said Anja Streicher, Women of Wearables chief marketing officer. Samphire Neuroscience and Amira Health demo wearable solutions for PMS and hot flashes at Wired Health.


NHS England Abolition Fits UK Drive To Balance Regulation With Innovation

 
• By 

Centralized decisions and cost savings are targeted in the UK government’s plan to combine much of NHS England with the Department of Health and Social Care. The action will likely divert resources away from health ministry efforts to launch the 10-Year Care Plan, but how else will medtechs be impacted?

Careology And Entia Partner To ‘Enhance’ Remote Monitoring For Patients With Cancer

 

Careology and Entia are partnering to “alleviate the burden of routine patient assessments” on people with cancer. The two early-stage London-based health tech startups already provide services to UK National Health Service (NHS) patients.

Industry Gives Broad Welcome To Abolition Of NHS England But Needs Time To Weigh Impact

 
• By 

Insight into the knock-on effects on innovation adoption and procurement is keenly awaited by medtechs.

UK MHRA Holds 2025 Device Registration Fee Increase

 
• By 

Most fees and fee uplifts proposed by the UK MHRA to begin in April 2025 will be implemented on schedule. A general 8.85% increase will be applied to all statutory fees, but the new medical devices registration fee is subject to ongoing review and/or alternative options.


Leadership Changes In UK Healthcare: Medtech Pledges To Work With New MHRA Chief Executive

 
• By 

Lawrence Tallon will succeed June Raine as MHRA chief executive on 1 April. UK medtechs will prioritize an early meeting with the man who since 2020 has served as deputy chief executive of Guy’s and St Thomas' NHS Trust.

Prostate Cancer Research Urges UK To Implement Screening Program Without Delay

 

Implementing a reflex test alongside traditional prostate cancer screening is cost-effective for high-risk groups, claims Prostate Cancer Research. Oxford BioDynamics sheds light on UK market conditions influencing the adoption of its reflex test, EpiSwitch PSE.

EU Law First Up As UK MHRA Reopens Work On Pre-Market Medtech Regulation

 
• By 

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.

New AI Tool Spots ‘Invisible’ Epilepsy Brain Lesions Missed By Radiologists

 

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.


‘The World Doesn’t Need Another Digital Health App’ Says Health Tech Innovator Mike Trenell

 

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.

Digostics At-Home Type 1 Diabetes Test Trialed In Children For Routine UK NHS Use

 

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.

UK HTA Body NICE Promises Positive Shake-Up For Medtech Users

 
• By 

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' CRC Diagnostic Test Could Reduce Unnecessary Patient Follow-Ups

 

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.


Post-Market Surveillance: The Rock On Which UK’s Global Regulation Ambitions Will Be Built

 
• By 

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.

FDA Tissue Biopsy Draft Guidance Could Boost Liquid Biopsy Adoption In Clinical Trials

 

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.

Front Line Medical Counts On Fast UK Access For COBRA-OS REBOA Device

 

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.

Angle Shares Up After New Research Released In Partnership With Illumina

 

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.