
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, five‑electrode setup. Weighing only 0.13 kg, it cuts acquisition time by roughly 30% versus traditional carts, expanding access in primary‑care, urgent‑care and remote settings. Since its U.S. FDA clearance in June 2024, the system has identified over 4,000 MI and ischemia cases worldwide.

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...