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Ben Kemp

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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
BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

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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QServe and TUV SUD – Navigate AI in MedTech: Live Regulatory Insights

We'd like to invite you to a live, practical webinar on Ensuring Quality in AI Driven Devices, hosted by Qserve experts and a guest speaker from Notified Body TÜV SÜD. We will unpack the regulatory expectations, explain what TÜV SÜD assesses during a submission review, and share examples from real-world cases, including those involving AI-supported clinical evaluation activities. Thursday, January 29,…
Ben Kemp
January 23, 2026
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