The Government has confirmed it will accept all 44 recommendations made by the National Commission into the Regulation of AI in Healthcare. Alongside the response, the MHRA is opening the call for applications for the third phase of AI Airlock, its regulatory sandbox for AI-enabled medical devices.
Features
Hepatitis C virus testing: a route to disease elimination
The World Health Organization targets global elimination of hepatitis C by 2030, aiming for a 90% reduction in new cases and a 65% drop in mortality, and testing is pivotal to achieving this goal. Here, Pathology in Practice Science Editor Brian Nation looks at recent published work in this area.
Automating familial hypercholesterolaemia genetic testing
Silvia Borras of NHS Grampian – part of the Scottish Strategic Network for Genomic Medicine – writes for Pathology in Practice, describing her laboratory’s experience of scaling up and automating its genetic testing for familial hypercholesterolaemia.
Products
OGT marks start of CytoCell IVDR transition with new prenatal FISH probe kits
OGT, a global provider of genomic research and diagnostic solutions, has announced its commitment to transition the full CytoCell fluorescence in situ hybridisation (FISH) probe portfolio from CE marking under the IVD Directive (IVDD) to the IVD Regulation (IVDR).
Leica Biosystems expands digital pathology capabilities
Leica Biosystems has announced multiple U.S. Food and Drug Administration (FDA) 510(k) clearances that strengthen its connected clinical digital pathology portfolio, translating digital pathology innovation to clinical impact by accelerating workflows and patient care.
Cepheid unveils third-generation GeneXpert system
Molecular diagnostics firm Cepheid will unveil the third generation of the GeneXpert system at the upcoming Association for Diagnostics & Laboratory Medicine (ADLM) Annual Scientific Meeting.
First fully automated diagnostic for hepatitis D virus
Roche has introduced a new hepatitis D virus (HDV) test, the first fully automated diagnostic solution to identify the most severe form of viral hepatitis.
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Beckman Coulter Diagnostics is a global leader in advanced diagnostics, helping laboratories transform insight into impact through science, technology, and collaboration. For more than 90 years, the company has challenged convention to elevate the role of the diagnostic laboratory, accelerating ideas from discovery to real world clinical outcomes....
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