U.K.-based software, dubbed MEMORI, gains first certification as a medical device, able to predict infections in real-time
In a significant development for the healthcare sector, Sanome's AI-enabled warning system, MEMORI, has secured Class IIb CE certification and MHRA approval. This UK-built tool is designed to predict and prevent Healthcare-Associated Infections (HAIs) up to 72 hours earlier than current gold standard tools.
MEMORI was created with a personal mission in mind. Benedikt von Thuнгen, Sanome's Founder and CEO, stated that the system was developed to prevent experiences like his father's, where early warning signs were missed in a hospital setting. Lord James Bethell, a former Health Minister and member of the House of Lords, praised MEMORI as a transformative tool that allows clinicians to act sooner with more targeted interventions, saving lives and reducing the pressures on an already burdened system.
The AI system analyses live patient data, including vitals, and clinical notes from the electronic patient record (EPR), delivering explainable alerts directly into a clinician's workflow. This approach aims to give clinicians a window into the future, providing insights and tools to act before it's too late, without creating additional burden.
MEMORI's Class IIb certification is among the most rigorous for medical software in Europe, covering devices used to support diagnosis or clinical management. This significant milestone in Sanome's journey demonstrates the ability to do so safely and at scale.
The company is expected to announce additional partnerships and validation results in the UK, Europe, and US later this year. Sanome is also collaborating with NHS Trusts and technology providers on various data-sharing initiatives, with a focus on securing FDA approval.
The global network supporting safe AI use in healthcare now spans major regulatory bodies from North America, Europe, and Asia-Pacific. Along with the UK MHRA, the other countries involved in this new network include the United States (FDA), Canada (Health Canada), China (NMPA), Japan (MHLW/PMDA), South Korea (MFDS), and the European Union (EMA). This collaboration aims to align regulatory frameworks and accelerate access to safe, effective AI-enabled medical technologies worldwide.
Sanome's expert advisory board, consisting of leading experts such as Dr Michelle Tempest, Pam Garside, Dr Cem Baydar, Lord James Bethell, Dr Arrash Yassaee, and Prof Carole Longson, further evidences Sanome's role in helping to shape the future of healthcare.
HAIs cost the NHS around 2.7 billion GBP annually, with HAIs responsible for an additional 7 million hospital bed days annually. By detecting and forecasting HAIs earlier, MEMORI has the potential to significantly reduce these costs and improve patient outcomes.
In conclusion, MEMORI's Class IIb CE certification and MHRA approval mark a crucial step forward in the fight against HAIs. This UK-grown solution, combining world-class science with a deep understanding of frontline healthcare, is poised to make a significant impact on the global healthcare landscape.
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