Sanome’s AI tool gains certification for early detection of hospital infections
Ella Day | August 7, 2025 | News story | Business Services, Research and Development | AI, Devices, Infections and infestations, Medicines and Healthcare products Regulatory Agency, NHS, Sanome, hospital-acquired infections
Sanome’s MEMORI, an artificial intelligence (AI) medical device that can predict hospital-acquired infections up to 72 hours before they present, has received Class IIb CE certification and approval from the Medicines and Healthcare products Regulatory Agency (MHRA). This marks the first UK-built AI software to receive this level of certification for infection prediction.
The tool analyses live clinical data – including vital signs and clinician notes from electronic patient records – and issues infection risk alerts directly to healthcare teams. It is designed to integrate into existing workflows without requiring additional logins or processes.
Healthcare-associated infections are a significant burden on health systems. In the UK, they account for approximately £2.7bn in annual NHS costs and contribute to an estimated seven million additional hospital bed days each year. Class IIb certification applies to software that supports diagnosis or clinical management and is among the most stringent levels of regulation for medical devices in Europe.
The announcement comes alongside the appointment of several new strategic advisors to Sanome, including former Health Minister Lord James Bethell, former National Institute for Health and Care Excellence (NICE) executive director Carole Longson and NHS England deputy director Arrash Yassaee.
MEMORI is currently in use with NHS partners and is undergoing further validation, while preparations for US Food and Drug Administration (FDA) submission in the US are underway.
Ella Day
7/8/25
This article featured in: September 2025 – The Pharmafile Brief
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