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The Justification of Practices Involving Ionising Radiation Regulations 2004: guidance on their application and administration

The Justification of Practices Involving Ionising Radiation Regulations 2004: guidance on their application and administration Page summary: Guidance on the application of the regulations and the administrative procedures that will be used by government in reaching justification decisions. Change made: The guidance has been updated to reflect a change in contact details for the Justification Application Centre, legislative and departmental…
Ben Kemp
October 21, 2025
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Media Monitoring: 16th – 22nd October

One in six bacterial infections worldwide are now resistant to antibiotics, WHO warns The World Health Organization (WHO) has warned of a sharp rise in antimicrobial resistance (AMR), with one in six bacterial infections worldwide now resistant to antibiotic treatments. WHO’s latest global surveillance report found that antibiotic resistance rose in over 40% of the pathogen-antibiotic combinations monitored from 2018…
Ben Kemp
October 21, 2025
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BIVDA meet Shadow Health Minister Lord Kamall

Last week, BIVDA's Helen Dent and Ben Kemp met with Shadow Health Minister Lord Kamall in the House of Lords. The peer was pleased to hear about BIVDA's ongoing advocacy efforts and key strategic objectives, as well as the challenges facing UK IVD companies. Lord Kamall, who was previously Life Sciences Minister under Boris Johnson, possesses a significant interest in…
Ben Kemp
October 21, 2025
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BIVDA provides Budget and Life Science Investment Inquiry submissions

In the last week, BIVDA have provided submissions to the Treasury ahead of the Budget on the 26th November and to the Commons' Science, Innovation and Technology Committee for their emergency inquiry into life sciences investment in the UK. The latter was prompted by high-profile withdrawals from the UK's life science sphere, notably Merck's recent decision to scrap a £1bn…
Ben Kemp
October 21, 2025
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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
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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
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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
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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