The Infection Management Coalition (IMC), of which BIVDA is a member, welcomes the publication of the Independent Investigation of the NHS in England, conducted by Lord Ara Darzi. Its findings highlight the persistent challenges in infection prevention and control (IPC), antimicrobial resistance (AMR) and uptake and investment in diagnostics. Progress in all three areas has been slow and urgent action is needed to reduce the devastating impact of infection on people, the NHS and the UK economy.

The diagnostic industry is ready to support the NHS to resolve the issues identified in the Darzi Review. The Review makes stark reading; the Prime Minister assesses it as “reform or die”. Poor policy, austerity, and the pandemic have crippled the NHS. Systemic and structural pressures throughout the NHS have normalised appalling service.

ISO 13485 is the harmonized standard for Quality management system (QMS) in the medical device industryUpfront diagnostics announced today that their LVOne has been awarded EN ISO 13485:2016 Quality Management System (QMS) certification. This certification follows the design, development, manufacturing, and distribution of a rapid blood test for the diagnosis of stroke patients, highlighting the company’s adherence to rigorous quality standards.ISO13485 focuses on patient safety by ensurin...

Hugo Technology is proud to announce that it has joined the growing group of companies who are part of the Asker Healthcare Group.

London, 4th September 2024 – Fast MDx, the developers of the world’s first low‑cost, high‑throughput molecular diagnostic test system, today announced CE-IVDr marking for its flagship NGX 124 platform, following the signing of a Declaration of Conformity to the IVD Regulation 2017/746. CE-IVDr marking represents the latest milestone in the on-going development of NGX 124 and paves the way for an official launch in Autumn 2024.  Jointly designed and developed by Fast MDx a...

Tuesday 3 September 2024 – AMLo Biosciences Ltd (Newcastle upon Tyne, UK) announce the successful receipt of the UKCA mark for AMBLor. AMBLor is a groundbreaking histopathological biomarker test for the personal identification of early-stage melanomas at low risk of progression, post staging diagnosis. This is the first in vitro diagnostic (IVD) of its kind that can reliably stratify non-ulcerated AJCC stage I-II melanomas that are unlikely to metastasise, potentially segmenting a group of...

BIVDA welcomes the UK's official accession to the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) by 15 December 2024.CPTPP is a free trade area spanning five continents and encompassing almost 600 million people following the UK's accession. More than 99% of current UK goods exports to CPTPP members will be tariff-free, driving important economic growth.On the announcement, BIVDA's Head of Policy, Programmes and Compliance Paul Fisher said, "T...

We are pleased to see the UK Government has launched a joint public-private investment programme worth up to £400 million, which is set to boost UK clinical trials. This aims to provide NHS patients with earlier access to new treatments and help the UK become the home of cutting-edge health research.

BIVDA send our congratulations to Sir Keir Starmer and The Labour Party after winning the 2024 General Election.The new government face significant challenges, particularly economically and in health. The UK's diagnostic industry offers solutions to both these challenges.BIVDA has been working closely to support the potential new government since before the election was announced. We know that the life science sector is a key priority for Labour, and we call on the government to rapidly set ...

BIVDA continues to strengthen our team, and we are delighted to welcoming Beth Loudon as our new Head of Market Access from September 2024. Beth is currently the Medical and Surgical Consumables Director for NHS Supply Chain, leading the clinical and commercial team responsible for assurance of value and resilience for the supply of clinical goods to the NHS.