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UK reforms highlight the case for digital submissions in medical device regulation
Diogo Geraldes, director of regulatory strategy, Europe at Veeva MedTech, discusses the potential of digital submissions to benefit manufacturers, regulators, and patients.
Wellcome backs MHRA and NICE’s digital mental health tech push with £2m funding
The funding from the Wellcome Trust will aid the entities in continuing their work on developing safety protocols around digital mental health technologies.
The transatlantic medtech investment gap: why does it exist and can it be plugged?
Ivor Campbell, CEO of medtech recruitment consultancy Snedden Campbell, reflects on what companies in the UK and Europe can do to compete for investment against the US.
NHS trials rapid blood test to diagnose serious infections in children
The project investigating the blood test is set to continue until March 2026.
Medtech devices becoming “learning systems”, says Google Cloud exec
As agentic AI advances, the technology holds the potential to make medtech systems and devices more anticipatory.
MHRA establishes commission to advance AI deployment across the NHS
By rewriting the rulebook to clarify regulatory uncertainty around AI’s use in healthcare, the MHRA aims to position the UK as a global hub for health tech investment.
Cyted raises $44m to propel US market expansion of its endoscopic capsule
The British company plans to use the funds to drive commercialisation efforts for its GI diagnostics platform and expand its portfolio of tests.
Health institutions to have say in MHRA’s reforms for in-house manufactured medtech
The MHRA aims to refine a 2021 policy that exempts medical devices made and used by health institutions from certain requirements.
MHRA outlines UK medical device regulation amends
Proposals include establishing "indirect recognition" of EU CE-marked devices to the UK market and "international reliance" routes.
UK government targets manufacturing as it eyes £41bn life science sector growth
With the aim of being the largest life sector by 2035 behind only the US and China, the UK government is ramping up commercialisation.
Improving pharmacovigilance: How data-driven solutions are improving drug safety
Traditional pharmacovigilance has often been slow, reactive and dependent on manual reporting. Can innovative, data-driven solutions leveraging AI, machine learning and real-world data accelerate the detection of adverse effects, from clinical trial phase to post-market surveillance?
Genomics to roll out predictive clinical test across UK
The test is currently available in private healthcare facilities but there are hopes it may be adopted by the NHS.
New MHRA PMS requirements hit UK medtech industry
The new regulation tightens safety and performance monitoring rules for all medical devices placed on the UK market after 16 June 2025.
HistoSonics' histotripsy system receives early market access authorisation in UK
The authorisation for the histotripsy system was granted under the UK’s Innovative Devices Access Pathway (IDAP).
Capitalising on UK’s goal to become a world-leading clinical trial destination
The 12th Outsourcing in Clinical Trials UK & Ireland conference will focus on the region’s future as a clinical trials hub.
Progesterone delivery device nets £1m funding from UK's NIHR
Research indicates that leaky progesterone pessaries used in threatened miscarriage cases cost the NHS £236m in avoidable costs yearly.
MHRA approves trofolastat for prostate cancer diagnostic imaging
Trofolastat is a prostate-specific membrane antigen-targeting agent cleared for use with Technetium-99m for cancerous lesion detection.
MHRA launches new monthly safety bulletins
Covering medical devices and medicines, the bulletins are part of the MHRA’s three-year strategy to improve safety communications.
UKHSA unveils high-risk pathogen list to drive innovation
The agency has published a list of 24 high-risk infectious diseases as a reference tool for funders and researchers.
EDX Medical develops new ‘super test’ for prostate cancer
According to EDX, the test studies the most comprehensive range of clinically validated prostate-related biomarkers currently known.