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Paul Fisher

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New study shows MHRA collaboration with hospital DNA sequencing service cuts time to diagnose infections

In a UK-first, the Medicines and Healthcare products Regulatory Agency (MHRA) and Barts Health NHS Trust have developed a DNA sequencing approach that can be implemented onsite in hospitals so they can diagnose bacterial infections faster and more accurately. This service will help doctors deliver better-targeted treatments earlier. For patients, this means a quicker recovery, fewer complications such as sepsis,…
Paul Fisher
March 13, 2025
Membership NewsMembership News Archive

Impacted by DTAC or DCB0129? Let us know

BIVDA have been approached by a member concerned about both DTAC and DCB0129.  We are scoping the issue ahead of advocacy work. The Digital Technology Assessment Criteria for health and social care (DTAC) aim to give NHS staff and patients confidence that the digital health tools they use meet NHS clinical safety, data protection, technical security, interoperability and usability and…
Paul Fisher
March 13, 2025
Membership NewsMembership News Archive

DHSC plan to tackle rare diseases more effectively

The DHSC have launched their fourth action plan, setting out how they will implement the UK Rare Diseases Framework. Rare diseases, affecting fewer than one in 2,000 people, collectively impact over 3.5 million people in the UK. These conditions, while individually rare, are common when considered together. Examples include cystic fibrosis, Huntington’s disease, and muscular dystrophies, though many other rare…
Paul Fisher
March 13, 2025
Membership NewsMembership News Archive

MHRA pause plans to move to GMDN-based fees structure

MHRA announce pause in their proposal to move to GMDN-based fees structure. The MHRA have released their response to their October 2024 fees consultation. This proposed a new medical devices registration fee which would have significantly impacted the IVD industry, particularly SMEs, and was strongly opposed by BIVDA. The MHRA has decided to proceed with the wider fees uplift and…
Paul Fisher
March 13, 2025
Membership NewsMembership News Archive

BBC raise concerns over private at-home PSA testing

A BBC investigation has raised concerns over the accuracy and reliability of at-home prostate cancer tests, particularly rapid PSA (Prostate-Specific Antigen) tests. These tests detect elevated PSA levels in blood samples, which could indicate prostate issues, including cancer. However, the BBC's analysis of five different tests found significant inconsistencies: one test didn't work, three were negative, and one produced a…
Paul Fisher
March 13, 2025
Membership NewsMembership News Archive

COO at top of UKHSA

UKHSA appoint a new Chief Operating Officer and confirm Dyfed Alsop will cover as CEO after Jenny Harries Departure. Dyfed Alsop has been appointed as UKHSA’s new Chief Operating Officer and Deputy Chief Executive Officer, starting 1 May 2025. He has already begun working with UKHSA, attending meetings and building relationships across the agency, ahead of his formal start date…
Paul Fisher
March 13, 2025
Membership NewsMembership News Archive

Stephen Powis and other executives leave NHSE ahead of organisation’s merger with DHSC

England’s top doctor will leave his post in July, in the latest change at the top of NHS England. Professor Sir Stephen Powis, national medical director of NHS England, has announced that he will step down this summer, after over seven years in the role. Professor Powis notified outgoing NHSE Chief Executive Amanda Pritchard of his intention to stand down…
Paul Fisher
March 13, 2025
Membership NewsMembership News Archive

NHSE to be disbanded within two years

“I’m bringing management of the NHS back into democratic control, by abolishing the arms-length body NHS England.” says Sir Keir Starmer. After the departure of a number of executives in the last week, including chief executive Amanda Pritchard, it was clear that significant change was coming.  It has also been known for some time that the Health Secretary had reservations…
Paul Fisher
March 13, 2025
Membership NewsMembership News Archive

NIHR Respiratory Innovation Workshop

Join NIHR for a workshop bringing together respiratory innovators and leading experts in community healthcare. NIHR are hosting an interactive workshop on Wednesday 9th April at the historic University College Oxford. Perfect for companies developing respiratory devices and digital technologies, attendees will benefit from: – Individual feedback from NHS specialists, researchers, patients & commissioners – Expert guidance on evidence requirements…
Paul Fisher
March 5, 2025
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