MHRA outlines upcoming IVD submission shift for clinical trials
The Medicines and Healthcare products Regulatory Agency (MHRA) is formalising its review process around in vitro diagnostics (IVD) or companion…
The Medicines and Healthcare products Regulatory Agency (MHRA) is formalising its review process around in vitro diagnostics (IVD) or companion…
RevealDX has obtained US Food and Drug Administration (FDA) clearance for RevealAI-Lung, an artificial intelligence (AI)-based software for lung nodule…
GE HealthCare has gained simultaneous US Food and Drug Administration (FDA) clearance and a European CE mark for Allia Moveo,…
With the wearables market continuing to boom, smart patches could become the next big focus area for tracking healthcare metrics,…
Siemens Healthineers has cut the red ribbon on a new €10m ($11.85m) centre of excellence focused on immunoassay instrument R&D…
Spectrum Dynamics Medical has gained US Food and Drug Administration (FDA) clearance for the Veritas.AI Noise Reduction platform, setting the…
Stryker has achieved an 11.2% increase in revenue in 2025, fuelled by high growth in the company’s vascular business. The…
Recent developments in reimbursement and insurer coverage for plaque analysis in the US are a step towards the evaluative method…
With human-reliant protocols affecting factors including production line uptime and potentially resulting in errors, there is a rising interest in automation…
The Medicines and Healthcare products Regulatory Agency (MHRA) has published new resources that aim to prompt greater introspection into what…