RECENT NEWS

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a four-week consultation which will support improved safety for certain high-risk IVD devices.

Karius has announced that its Karius Test has been granted designation as a Breakthrough Device from the Center for Devices and Radiological Health (CDRH) of the US FDA, for use in the diagnosis and management of immunocompromised patients with suspected lung infections including lower respiratory infection and pneumonia.

Ibex Medical Analytics and Kameda Medical Center (Kameda), both feature in a newly published clinical study evaluating Ibex's Galen platform, which demonstrated excellent outcomes in detecting cancer and other pathologies in prostate and breast biopsies.

Sysmex has been recognised in the ‘Great Place to Work’ scheme, receiving the 41st position in the ‘Best Workplaces 2024 – Large Category’ list, after being certified last November. In 2023 Sysmex UK was also recognised as a Great Place to Work for wellbeing.

The National Institute for Health and Care Research (NIHR) has awarded £5 million for an NIHR HealthTech Research Centre Network, hosted by Sheffield Teaching Hospitals NHS Foundation Trust, from 1 September 2024.

Backed by a new award of £1.8 million, the Medicines and Healthcare products Regulatory Agency (MHRA) is to establish a dedicated team to provide regulatory scientific support for innovators creating novel antimicrobials and diagnostics as part of a programme led by the Department of Health and Social Care (DHSC) to support the international community in tackling the growing threat of antimicrobial resistance (AMR).

PathAI has announced the launch of Pathology Universal Transformer (PLUTO), a pathology-centric foundation model, to further differentiate the company’s portfolio of products geared towards biopharma and pathology laboratory customers.

Thermo Fisher Scientific has introduced the Applied Biosystems Axiom BloodGenomiX array and software, a first-of-its-kind solution for more precise blood genotyping in clinical research.

A package of up to £85 million to support the international community in tackling the growing threat of antimicrobial resistance has been announced by the UK Government.

Indica Labs has announced that it received FDA clearance for HALO AP Dx, an enterprise digital pathology platform, for primary diagnosis. This 510(k) clearance allows HALO AP Dx to be utilised in conjunction with the Hamamatsu NanoZoomer S360MD Slide scanner for in-vitro diagnostic use and sets the stage for use with additional FDA-cleared slide scanners in the future.

Danaher has launched a collaboration with Johns Hopkins University aiming to develop new methods for diagnosing mild traumatic brain injury (TBI). As part of the Danaher Beacons program, researchers at Johns Hopkins University will leverage technology from Danaher subsidiary Beckman Coulter Diagnostics to potentially establish correlations between a new biomarker panel and clinical outcomes.

Harnessing the power of CRISPR gene-editing technology in a new way, University of Florida researchers have created a one-tube testing method targeting DNA from body fluids that has the potential to dramatically increase access to the diagnosis of viral diseases such as cervical cancer.

A newly discovered Zika virus-specific synthetic molecule is capable of differentiating Zika-immune patient samples from samples of patients previously infected with the related dengue virus. The technology may lead to the development of better diagnostics and vaccine candidates.

Applied Cells has announced the launch of its MARS Ingenuity Reagent kits for fast and easy cell isolation. This innovative product line features both RUO and GMP-grade reagents, and has been specifically optimised for use on Applied Cells’ proprietary MARS Bar platform.

Registration is now open for the Infection Diagnostics Symposium, hosted by BD, which aims to bring together professionals from the laboratory, ward and board across two days to discuss how a unified approach could improve infectious disease diagnostic pathways.

Construction work is underway for two new NHS community diagnostic centres (CDCs) in Lincolnshire as part of a £38million investment in services. The centres in Skegness and Lincoln represent a significant development in local NHS services, with the centre in Skegness believed to be the largest single NHS investment in the town in many years.

Beckman Coulter Diagnostics and MeMed, a leader in the emerging field of advanced host-response technologies, have announced the expansion of their host immune response diagnostics partnership.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched AI Airlock, its new regulatory sandbox for AI as a Medical Device (AIaMD). This initiative aims to address challenges for regulating medical devices that use AI.

The Association of British HealthTech Industries (ABHI) has published its manifesto which articulates a clear and actionable 10-point programme for government. This strategic blueprint is designed to harness the full potential of the sector to benefit patients, clinicians, and the UK economy.

The government has announced its new national action plan on antimicrobial resistance to protect people and animals from the risk of drug-resistant infections. The new document builds on the progress made in the previous five-year national action plan and supports the 20-year vision to contain and control AMR by 2040.