Sanome’s MEMORI, an AI medical device that predicts hospital-acquired infections up to 72 hours in advance, has secured Class IIb CE certification from the Medicines and Healthcare products Regulatory Agency (MHRA). This achievement marks it as the first UK-developed AI software of its kind to receive such certification. MEMORI leverages live clinical data—vital signs and clinician notes—delivering real-time infection risk alerts to healthcare teams, seamlessly integrating into existing workflows without disrupting processes.
Hospital-acquired infections impose a staggering burden on the UK’s NHS, costing approximately £2.7 billion annually and leading to around seven million extra hospital bed days. Class IIb certification denotes stringent regulation applicability for medical devices in Europe.
The announcement coincides with the addition of prominent strategic advisors, including former health minister Lord James Bethell, to Sanome’s team. Currently utilized by NHS partners, MEMORI is undergoing further validation and is preparing for FDA submission in the United States.
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