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Ben Kemp

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RADIANT CERSI Innovators Survey

The RADIANT CERSI has launched an innovators survey aimed at better understanding the regulatory challenges and support needs of digital health and AI innovators. The CERSI network is supported by MHRA and UKRI. RADIANT aims to bridge the gap between regulatory science and real-world innovation, creating a sustainable and inclusive ecosystem for SMEs and innovators in Digital Health and AI. RADIANT…
Ben Kemp
February 3, 2026
Membership NewsMembership News Archive

Launch of Healthcare Science Innovation Fellowship Programme in Wales

Applications for the Healthcare Science Innovation Fellowship programme have now opened. The programme is being delivered by the NIHR HeathTech Research Centre (HRC) in Long-Term Conditions (Devices for Dignity), supported by Health Education and Improvement Wales (HEIW) and Healthcare Science Cymru. The Innovation Fellowships offer an exciting opportunity for NHS Wales Healthcare Science professionals to gain experience and expertise in…
Ben Kemp
February 3, 2026
Membership NewsMembership News Archive

Submit your views about NICE and their Healthtech evaluation programme

BIVDA members are invited to share their views on NICE and their Healthtech evaluation programme. This survey is timely given recent BIVDA's recent roundtable with NICE and any insight gained will help to inform future communications. The survey will take around 5 minutes to complete. It closes at midnight on Sunday 8 February 2026. In exchange for your support with…
Ben Kemp
February 3, 2026
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NIHR: Introduction to the EU Diagnostic Medical Devices Regulation (EU) 2017/746 – Online interactive workshop

🕰️ Tuesday, 24 February 2026, 10am to 12pm Are you developing a in vitro diagnostic device for the health sector? Are you unsure if you need to adhere to the In Vitro Diagnostic Medical Device Regulations? Or what the risk classification of your device is according to the In Vitro Diagnostic Medical Device Regulations? Or which requirements your device need…
Ben Kemp
February 3, 2026
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Blood test predicts response to breast cancer treatment

New research suggests that a simple blood test could help predict how patients with advanced breast cancer will respond to targeted treatments, even before therapy starts. Scientists found that measuring tiny fragments of cancer DNA circulating in the bloodstream may offer early clues about whether a treatment is likely to be effective. The study was carried out by researchers at…
Ben Kemp
February 3, 2026
HighlightsHighlights Archive

Groundbreaking study could lead to diabetes screening for children

Researchers suggest that all children in the UK could one day be routinely screened for type 1 diabetes using a quick finger-prick blood test, following encouraging results from a large national study. At present, many children are not diagnosed until they become seriously unwell. This puts them at risk of diabetic ketoacidosis, a dangerous condition that requires emergency hospital care.…
Ben Kemp
February 3, 2026
Membership NewsMembership News Archive

DHSC: Product Information Management system (PIM) – opportunity for members

DHSC has invited BIVDA members to be future Data Providers to the PIM service and to participate in testing the early prototype of it. DHSC would value members' expert opinion on PIM which will be a trusted, central platform for medical device product information, enabling users across the NHS to easily access accurate, high-quality data to support safe, informed care…
Ben Kemp
February 3, 2026
HighlightsHighlights Archive

Government announces new three-year Neighbourhood Early Diagnosis Fund for cancer

Patients in deprived and underserved areas will receive potentially life-saving earlier cancer diagnosis through a new £200 million scheme to tackle postcode lotteries in cancer care. Local communities across England will benefit from the major investment, aimed at reducing cancer screening inequalities and catching more cancers early. From 2026, Cancer Alliances - regional NHS partnerships that co-ordinate cancer services -…
Ben Kemp
February 3, 2026
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BIVDA cited in Parliament as MHRA annual fees are announced

Health Minister Baroness Merron last week announced in Parliament that MHRA fees will be set at £300 per year, based on Level 2 GMDN terms. This will take effect from 1 April 2026 to fund the MHRA’s post-market surveillance (PMS) activities. Overall, this move has been welcomed by BIVDA members. We were glad that the MHRA reconsidered the initial fees…
Ben Kemp
February 3, 2026
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FDA Consensus recognized standards update 20260219

Dear members please see a stripped down version of the FDA Consensus recognised standards update 19th Feb 2026. I’ve removed irrelevant subject matter entries and highlighted those in Green that maybe relevant to IVDs. Original source : Federal Register :: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 065
Ben Kemp
February 2, 2026
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