Medical Device Regulator Seeks Stakeholder Views on New Premarket Requirements
UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has opened a stakeholder impact survey on its draft Medical Devices (Amendment) Regulations 2026, which propose new pre‑market requirements for medical devices and in‑vitro diagnostics. The consultation, published on the WTO notification portal, seeks evidence on costs, benefits, and implementation from manufacturers, clinicians, patients, and trade bodies. Responses are due by 19 June 2026, after which the MHRA will refine the regulations to prioritize patient safety and faster access to innovative technologies.
The Benefits of Molecular Testing in Acute Gastroenteritis Diagnosis
Acute gastroenteritis remains a leading global health burden, causing over one million deaths in 2021 and driving more than 770,000 hospital discharges annually in Europe. Bacterial pathogens such as Campylobacter, Salmonella and STEC dominate cases, while rapid, accurate diagnosis is...
Rachele Nardella | Meet the Speakers: Med-Tech Expo 2026
Regulatory body updates ISO 10993‑1 to its 2025 edition, prompting medical device makers to rethink biocompatibility planning. At Med‑Tech Expo 2026, TÜV SÜD’s Rachele Nardella will show how the new standards can be turned into a cost‑saving, timeline‑protecting strategy. Her session focuses...
Endometriosis Imaging Study Highlights 99mTc-Maraciclatide as Diagnostic and Monitoring Tool
Serac Healthcare and Oxford’s Nuffield Department have published Phase 2 results of the DETECT study, showing that the gamma‑emitting radiotracer 99mTc‑maraciclatide can non‑invasively locate endometriotic lesions, including superficial peritoneal disease. Imaging findings matched laparoscopy in 16 of 19 participants and identified disease...
“Value Doesn’t Run April to April” – Prof Andrew Stradling on NHS’s New Value Based Procurement Pilots
Prof Andrew Stradling, chief medical officer of the NHS London Procurement Partnership, outlined the NHS’s new value‑based procurement pilots running across 13 trusts. He warned that the current focus on easy clinical metrics such as infection rates and readmissions fails to capture...
Lesley Plön | Meet the Speakers: Med-Tech Expo 2026
MintNeuro and Motif Neurotech have teamed up to develop a miniature brain‑computer interface aimed at treating mental‑health conditions. At Med‑Tech Expo 2026, Lesley Plön of the Johner Institute, together with Margarita Rozhdestvenskaya, will present a session on regulatory compliance throughout...
Tarn Brown | Meet the Speakers: Med-Tech Expo 2026
At Med‑Tech Expo 2026, Columbus Global’s Tarn Brown will discuss turning regulatory compliance into a competitive edge. She argues that regulations are intended to support safety and can be leveraged through digital technologies to streamline the compliance process. Brown highlights...
Dr. Mohsin Amin | Meet the Speakers: Med-Tech Expo 2026
Founder and CEO Mohsin Amin of Orion Microbiology will speak at Med‑Tech Expo 2026 about placing microbiology at the front of the R&D checklist. His session, “Why Microbiology Shouldn’t be Last on the Checklist,” is slated for Day 1 on June 3,...
Jacqui O’Connor | Meet the Speakers: Med-Tech Expo 2026
Jacqui O’Connor, founder and managing director of MedScan3D, will speak at Med‑Tech Expo 2026 on June 3, unveiling how modern anatomical modeling reshapes the “Concept to Clinic” pathway. Her talk highlights the impact of high‑fidelity 3D simulation on accelerating medical device...
Winners Announced at Medilink Healthcare Business Awards
The Medilink North of England Healthcare Business Awards 2026 returned to Sheffield’s Cutlers’ Hall, marking the association’s 30‑year anniversary. Nearly 300 delegates gathered to honor achievements across medical technology, digital health, sustainability and NHS partnerships. Winners included Mitotype Precision Labs,...
Thermo Fisher Scientific Launches Applied Biosystems PowerFlex Thermal Cycler
Thermo Fisher Scientific unveiled the Applied Biosystems PowerFlex Thermal Cycler, a next‑generation PCR instrument that emphasizes speed, precision, and flexibility. The system features a 10.1‑inch touchscreen, AI‑driven Smart Help, and two configuration options—a 96‑well plate and a 3 × 32‑well layout with...
Debbie East-Nuttall | Meet the Speakers: Med-Tech Expo 2026
Debbie East‑Nuttall, Head of Medical Business Development at Kiwa, will present at Med‑Tech Expo 2026 on simplifying ISO 13485 compliance and setting realistic market‑entry timelines. Leveraging 35 years of industry experience, she will expose common pitfalls that delay approvals. The session,...
PlaqueTec Closes $5 Million Financing
PlaqueTec, a MedTech firm specializing in intracoronary liquid biopsy, announced a $5 million financing round, fully subscribed by existing investors. The capital will fund the expansion of its proprietary cardiovascular data lake, BioCarta, which aggregates proteomic and clinical data from the...
Sheffield’s New Cancer Robot Cuts Its Own Ribbon
Sheffield Hospitals Charity donated a record £1.45 million (about $1.84 million) to install a dual‑console da Vinci Xi surgical robot at Northern General Hospital. The system enables surgeons to perform minimally invasive procedures on lung, oesophageal, stomach, bowel, liver, pancreas and kidney...
NICE Launches Consultation on New Topic Prioritisation Framework
NICE has opened a consultation to overhaul its topic prioritisation manual, aligning it more closely with NHS priorities and national policy. The proposed changes introduce clearer priority definitions, merge the two‑stage framework into a single streamlined process, and adopt a...
Value Based Procurement on Target for June Launch, but Challenges Remain
The UK Department of Health and Social Care (DHSC) is on track to launch its new value‑based procurement (VBP) assessment methodology in June, with senior officials slated to present at the Med‑Tech Expo and NHS Confederation events. Workshops and training...
New Study Published Evaluating PharmaSens All-in-One Insulin Patch Pump
PharmaSens AG announced that the Journal of Diabetes Science and Technology published data from the first clinical feasibility study of its niia all‑in‑one insulin patch pump, which combines insulin delivery with continuous glucose monitoring. The single‑arm trial enrolled 18 adults...
New Tool Launches to Support Women Through Post-Loss Journey
Carea has introduced a free "Healing After Loss" mode within its pregnancy and postnatal wellbeing app, offering on‑demand mental‑health tools, expert guidance, and a peer community for women who have experienced miscarriage or baby loss. The feature activates automatically when...
A Pivotal Year for Regulatory Reform and Innovation
Britain’s Medicines & Healthcare products Regulatory Agency (MHRA) is advancing its MedTech regulatory reform, introducing a pre‑market statutory instrument that adds an international reliance scheme, updated classification, mandatory UDIs and stricter claim rules. The agency also plans an Early Access...
Making MedTech Events Deliver Real Impact – How Medilink UK Supports High-Value Engagement Across the Sector
Medilink UK offers a coordinated national event‑management service that blends regional expertise with a UK‑wide life‑science network. The model helps medtech, biotech and digital‑health organisations design and execute conferences, exhibitions and workshops that prioritize high‑quality stakeholder engagement over mere attendance....
Patient Safety Commissioner to Hold “Ask Me Anything” Session on AI in Healthcare
The UK Patient Safety Commissioner, Professor Henrietta Hughes, announced an online “Ask me anything” session on May 20 to gather patient perspectives on AI in healthcare. The forum will feature Professor Alastair Denniston, chair of the National Commission into AI...
Government Pledges £1.5 Million for FemTech Devices
The UK government has committed roughly $1.9 million (£1.5 million) to a new FemTech healthcare challenge under its Women’s Health Strategy. The grant scheme will fund NHS trusts to partner with promising FemTech developers, especially those delivering community‑service models that address health‑inequality...
Wrightington, Wigan, and Leigh Teaching Hospitals Unveil Results of Digital Transformation
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust partnered with Altera Digital Health to embed National Emergency Laparotomy Audit (NELA) guidance into its Sunrise electronic patient record. The digital overhaul of the Acute Abdomen Pathway drove 100% documentation compliance,...
DELO Expands Medical Electronics Portfolio with Five New IBOA-Free Adhesives
DELO Industrial Adhesives has introduced five new IBOA‑ and TPO‑free adhesives for medical electronics, adapting proven semiconductor and consumer‑electronics formulations for biocompatible use. The flagship MG4202 cures in just one second under a 1000 mW/cm² LED and operates from –40 °C to...
Doctor Care Anywhere Selects Tandem Health as AI Care Partner for Virtual Clinical Workflows
Doctor Care Anywhere, a leading UK digital health provider, has partnered with Tandem Health to embed its AI operating system into the virtual primary‑care platform. The integration will automatically capture consultations and generate structured medical records for the company’s 60,000...
AliveCor Launches “World First” Kardia 12L ECG in Europe
AliveCor secured CE Mark for its Kardia 12L, the world’s first AI‑powered, portable 12‑lead ECG system, and is launching it across major European markets. The device uses KAI 12L AI to detect 35 cardiac conditions, including acute myocardial infarction, from a single‑cable,...
Radical Catheter Technologies Announces FDA Clearance for 6F Neurovascular Catheter
Radical Catheter Technologies announced FDA 510(k) clearance for its 6F neurovascular access catheter, expanding its cleared portfolio to three devices. The 6F catheter’s thin‑wall, ribbon‑based design delivers a larger inner lumen while maintaining flexibility, pushability, and stability for both radial...
NHS Investment Brings Diagnostics Closer to Home
The UK government has allocated roughly £237 million (about $301 million) to launch and expand 36 Community Diagnostic Centres (CDCs) across England. Four brand‑new CDCs will open in Gorton, Luton, Boston and Bideford during 2026/27, while 32 existing sites receive upgrades. Seventeen...
Cartherics and Catalent Expand Commercial License Agreement
Cartherics and Catalent have signed an amended commercial license agreement granting Cartherics access to Catalent's cGMP‑compliant iPSC line for manufacturing its CAR‑NK cell therapies, including lead candidate CTH‑401. The partnership enables Cartherics to use the line for development, clinical trials,...
From Reactive to Proactive: Building the Digital Front Door for the NHS
In a video interview, Mark Ratnarajah, a paediatrician and UK Managing Director at Sword Intelligence, outlines how Agentic AI is being deployed as a digital front door for the NHS. The technology promises a 74% cut in delivery costs and...
Guideways Launches AI Platform to Get Life-Changing Medical Devices to Patients Faster
Guideways has launched an agentic AI platform designed to streamline FDA approval for medical devices. The system deploys three specialized AI agents—FDA Sherpa, FDA Reviewer, and FDA Researcher—to guide teams from concept through submission, leveraging a curated knowledge base of...
Roche Diagnostics Launches New Glucose Monitoring Device for Predicting Overnight Hypoglycemia in UK
Roche Diagnostics announced that its Accu‑Chek SmartGuide continuous glucose monitoring system is now reimbursable on the NHS, making the AI‑driven device available to adults with diabetes in the UK. The system uniquely predicts nighttime hypoglycaemia up to 30 minutes in...
Gloucestershire Royal Hospital Expands Cardiac Pacing Services with Specialist Angiography X-Ray System
Gloucestershire Royal Hospital has installed Canon Medical’s Alphenix Core+ angiography X‑ray system to expand its cardiac pacing services. The new system supports around 700 pacemaker implantations, 300 rhythm procedures and 2,000 angiograms annually, while offering ultra‑low radiation and AI‑driven image...
One Ticket, Eight Events: The UK’s Leading Manufacturing and Engineering Gathering Returns in June 2026
The UK’s premier manufacturing and engineering exhibitions will converge at the NEC Birmingham on 3‑4 June 2026, offering a single ticket to eight distinct events. Attendees can explore med‑tech, plastics, additive manufacturing, smart factories, drives, controls and more across multiple halls. Hundreds...
AI Could Help NHS Clinicians Diagnose Childhood Sleep Apnoea, Study Finds
Seluna’s AI‑driven autoscoring software accurately identified paediatric sleep apnoea in a 500‑patient NHS trial, achieving 100 % sensitivity for severe cases and processing each study in under five minutes. The platform matched human inter‑scorer variability while dramatically cutting analysis time from...
Boston Scientific Receives FDA Clearance for the Asurys Fluid Management System
Boston Scientific announced FDA 510(k) clearance for its Asurys Fluid Management System, a device that provides automated irrigation and intrarenal pressure control during endoscopic urologic procedures such as ureteroscopy. The system integrates with the LithoVue Elite single‑use digital ureteroscope, allowing...
Wireless Medical Device Compliance: Free White Paper
Wireless functionality is now standard in medical devices, but it adds a parallel set of regulatory hurdles across global markets. Manufacturers must secure CE RED, UKCA, FCC, and ISED approvals in addition to traditional device clearances, even when using pre‑certified...
What the UK’s Pandemic Preparedness Strategy Means for the MedTech Sector
The UK Department of Health and Social Care released a new Pandemic Preparedness Strategy that shifts pandemic planning from a reactive stance to a standing policy priority. It calls for scalable diagnostic capacity, stronger supplier resilience, and expanded strategic stockpiles,...
Military Medics Trial AI for the Battlefield
The UK Defence Science and Technology Laboratory teamed with the US DARPA under the In the Moment program to test AI‑aligned battlefield medical triage. Trials in October 2025 at Merville Barracks and Brize Norton used VR scenarios where AI mimicked a...
Medilink to Celebrate 30-Year Milestone with Spectacular Awards Evening
Medilink North of England is celebrating its 30th anniversary with a high‑profile awards evening at Sheffield’s Cutlers’ Hall on 30 April. The ceremony will recognize excellence across ten categories, from innovation and digital health to export achievement, sustainability and partnership with...
Asclepius MedTech Limited Named Winner of Big Ideas Challenge
Leeds‑based Asclepius MedTech Limited won the Mayor’s Big Ideas Challenge, receiving £100,000 (≈ $127,000) to scale its Surgfit remote monitoring system. Surgfit uses a disposable wearable sensor to replace hospital visits for pre‑ and post‑operative assessments, aiming to reduce missed risk...
NHS Supply Chain Commits to Adoption of Value Based Procurement
NHS Supply Chain has formally committed to applying a new value‑based procurement methodology, co‑created with the Department of Health and Social Care, to all its purchasing activities. The framework, developed over three years, will be rolled out across England and...
UK Dental Lab Reports Major Surge in Business with Multi-Material 3D Printing Technology
Bant Dental, a UK family‑run lab, installed a Stratasys J5 DentaJet multi‑material 3D printer at its new Macclesfield facility, making its workflow 95 % digital. The printer can handle up to five materials in a single run, enabling colour‑accurate, translucent dentures,...
Hexagon’s First Geomagic Freeform Update Makes Personalised Medical Device Design More Accessible
Hexagon’s Manufacturing Intelligence Business Area has launched Geomagic Freeform 2026.1, introducing a subscription pricing option alongside perpetual licenses. The update adds a Deform Selection tool, Python scripting for workflow automation, and Haply Robotics haptic integration, while extending DICOM RTSTRUCT support...
Lab Thread’s Unified Lab Software Platform Available to Academic & Non-Profit Researchers for Free
Lab Thread has launched a free version of its Unified Lab Software Platform for academic and non‑profit researchers, allowing up to five users per organization. The cloud‑based suite bundles an electronic lab notebook, DNA sequence viewer, templates and project‑management tools...
Sartorius Addresses Structural Manufacturing Bottlenecks with Launch of Eveo Cell Therapy Platform
Sartorius is launching the Eveo Cell Therapy Platform, an integrated, modular system that consolidates cell selection, activation, gene editing, expansion, washing, concentration and formulation into a closed, compact footprint. The platform can process eight autologous patient batches simultaneously, boosting annual...
3D Printing Smaller Than a Human Hair: A BMF Deep Dive with John Kawola
Boston Micro Fabrication (BMF) showcased a dual‑resolution 3D printer capable of producing functional parts with tolerances in the tens of microns—smaller than a human hair. CEO John Kawola explained how the machine alternates between macro and micro modes, delivering both...
Brainomix Deploys AI Imaging Platform Across West Virginia University Health System Network
Brainomix has rolled out its AI imaging platform, Brainomix 360 Stroke, to all 25 sites in the West Virginia University Health System. The tool provides real‑time, automated analysis of stroke scans, helping clinicians decide on treatment and transfer. The deployment aims to...
Consultation on CE-Marked Medical Devices ‘Could Mark Major Boost to Both Patients and MedTech Growth Aims’
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on granting indefinite recognition to CE‑marked medical devices in Great Britain. Around 90% of devices used in the UK already carry CE marks, and the proposals aim...
MiniMed Expands Sensor Portfolio in Europe with CE Mark for MiniMed 780G
MiniMed Group, Inc. received CE Mark approval for its MiniMed 780G automated insulin delivery system to be used with Abbott's Instinct continuous glucose monitor, adding a 15‑day wear sensor to the existing 7‑day options (Guardian 4 and Simplera Sync). The Instinct sensor is...