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Ben Kemp

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Galleri test for 50 cancers yields exciting results in trial

The cutting-edge Galleri blood test, currently under evaluation by the NHS, has shown strong promise during a trial in detecting more than 50 types of cancer in people with no symptoms. In the US trial known as PATHFINDER 2, involving around 23,161 participants, the test found a “cancer signal” in 216 individuals and cancer was later confirmed in 133 of them,…
Ben Kemp
October 21, 2025
HighlightsHighlights Archive

Experts call for prostate cancer screening for men with BRCA1 and BRCA2 gene mutations

Prostate cancer guidelines should be updated so that all men aged 40 and over with BRCA1 or BRCA2 gene mutations are offered regular PSA testing, according to scientists at The Institute of Cancer Research (ICR), London. Their call follows new results from the international IMPACT study, which found that PSA screening detects more aggressive prostate cancers in men carrying BRCA1…
Ben Kemp
October 21, 2025
Membership NewsMembership News Archive

Resolving menopause: better diagnostics are needed to navigate a challenging time in women’s lives

To mark World Menopause Day on 18th October, BIVDA member TTP plc published a blog aiming to demystify menopause and highlight the need for better diagnostic tools to improve women’s health outcomes. TTP notes that menopause is still too often diagnosed by exclusion rather than precision, leading to delays in care, patient frustration, and inefficient treatment pathways. The company argues…
Ben Kemp
October 21, 2025
Membership NewsMembership News Archive

DHSC launch survey on local formularies for medical devices

The Department of Health and Social Care (DHSC) has launched a national survey to inform new guidance for local NHS formularies listing medical devices prescribed for home or community use. The move follows long-standing concerns about regional variation in how NHS organisations manage these formularies, which can affect patient access to suitable devices. While NICE offers general advice on formulary…
Ben Kemp
October 21, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Diagnostic tools selected for phase 2 of the MHRA’s AI Airlock Programme

Seven emerging AI healthcare technologies have been selected to move into the next phase of the MHRA’s AI Airlock programme, with pleasing number of diagnostic tools chosen. The cohort includes tools aimed at dramatically reducing waiting times for tests, such as shrinking a bowel cancer screening process from weeks to minutes, and detecting conditions such as skin cancer, genetic eye…
Ben Kemp
October 21, 2025
Membership NewsMembership News Archive

Ben attends launch of the National Laboratories at LGC’s new purpose-designed facility in Guildford

Ben Kemp, BIVDA's Policy and Public Affairs Executive, was pleased to attend the Official Launch of the National Laboratories at LGC in Guildford on 17 October 2025. The National Laboratories at LGC are composed of three critical national functions; The National Measurement Laboratory (NML), the Government Chemist and the Medicines and Healthcare products Regulatory Agency’s (MHRA’s) chemical laboratories. These laboratories…
Ben Kemp
October 21, 2025
HighlightsHighlights Archive

Media Monitoring: 9th – 15th October

Nobel prize awarded for discovery of immune system’s ‘security guards’ Three scientists have been awarded the 2025 Nobel prize in physiology or medicine for discovering how the body stops its own immune system from turning against itself. Shimon Sakaguchi from Osaka University in Japan, Mary E. Brunkow from the Institute for System Biology and Fred Ramsdell from Sonoma Biotherapeutics, both…
Ben Kemp
October 15, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA issues updated guidance to reflect the implementation of the revised fee structure

The MHRA have issued the revised DORS Fees Guidance to reflect the implementation of the revised fee structure being implemented from 1st April 2026. We have extracted the key sections from the updated MHRA product registration webpage for members below. Fees from 1 April 2026 A new fee is planned to come into effect on 1 April 2026 and will…
Ben Kemp
October 15, 2025
Membership NewsMembership News Archive

BIVDA 2026 Regulatory Affairs Seminar agenda released

The agenda for BIVDA's 2026 Regulatory Affairs Seminar has been released. In addition to the closing keynote from MHRA Chief Executive Lawrence Tallon, other sessions will include major updates on international global harmonisation, the future of regulatory affairs, AI digital trust, UK MDR Pre-Market Requirements, and more. Each session will be accompanied by a workshop to ensure attendees are able…
Ben Kemp
October 15, 2025
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