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RECENT NEWS

MHRA proposes framework for international recognition of medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a statement of policy intent for international recognition of medical devices.

ACPCC future-proofs laboratory with Cirdan partnership

The Australian Centre for the Prevention of Cervical Cancer (ACPCC), a not-for-profit organisation with 60 years of expertise in cervical cancer prevention, has partnered with Cirdan to implement a state-of-the-art laboratory information management system (LIMS) to optimise and future-proof its laboratory workflows.

BIVDA welcomes MHRA's international recognition statement

BIVDA has welcomed a statement of policy intent published by MHRA for recognition by the UK of approvals of medical devices from international regulators.

MHRA consulting on tighter safety standards for IVDs

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 Test receives Breakthrough Device Designation

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.

Japanese study supports use of AI for breast and prostate cancer diagnosis

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 celebrates workplace recognition

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.

New network to provide national leadership for healthtech

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.

MHRA establishes new group to tackle AMR

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 introduces foundation model to enhance AI for pathology

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.

Array-based solution for extended blood type research

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.

UK pledges £85 million to tackle AMR

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 receives FDA clearance for HALO platform

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.

Partnership aims to develop new TBI diagnostics

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.

CRISPR innovation for cervical cancer diagnostics

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.

Synthetic biomarker technology differentiates between prior Zika and dengue infections

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.

Cell therapy reagent kits from Applied Cells

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.

Collaboration for better diagnostics – BD to host June symposium

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 begins on new CDCs in Lincolnshire

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 and MeMed extend diagnostics partnership

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.

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Upcoming Events

UK NEQAS Blood Coagulation: Clinical and Laboratory Haemostasis 2024

Sheffield Hallam University
5-6 June, 2024

Med-Tech Innovation Expo

NEC, Birmingham
5-6 June, 2024

LabMedUK24

DoubleTree by Hilton Brighton Metropole
10-12 June, 2024

Infection Diagnostics Symposium 2024

IET Austin Court, Birmingham
26-27 June, 2024

SHOT Symposium 2024

Mercure Manchester Piccadilly Hotel
9 July, 2024

Microbe Conference 2024

Crowne Plaza Hotel, Sheffield, UK
20-22 September, 2024

Access the latest issue of Pathology In Practice on your mobile device together with an archive of back issues.

Download the FREE Pathology In Practice app from your device's App store

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