AI tool gains Class IIB regulatory approval in UK first

Sanome has secured Class IIb CE certification and MHRA approval for MEMORI – an AI-enabled warning system for the early prediction/prevention of healthcare‑associated infections (HAIs).

The company has also appointed new strategic advisors, including former Health Minister Lord James Bethell and ex-Executive Director of National Institute for Health and Care Excellence (NICE), Prof Carole Longson.

HAIs are a major threat to patient safety. In the US and Europe, HAIs account for $28.4-45 billion and €13-24 billion in healthcare spending respectively.

In the UK ,the picture is also stark, costing the NHS around £2.7 billion, with HAIs responsible for an additional 7 million hospital bed days annually.

Now, MEMORI can directly support the ambitions of the NHS’s 10-Year Plan by enabling earlier intervention, reducing complications and cost, and ultimately increasing hospital capacity.

The platform helps clinicians detect and forecast HAIs up to 72 hours earlier than current gold standard tools, enabling faster, more accurate, life-saving decisions and reducing strain on the NHS.

Analysing live patient data, including vitals, and clinical notes from the electronic patient record (EPR), it delivers explainable alerts directly into a clinician’s workflow, with no extra logins or disruption, helping teams intervene faster and improve outcomes for patients.

Class IIb certification is among the most rigorous for medical software in Europe, covering devices used to support diagnosis or clinical management.

MEMORI is the first UK-built AI tool to reach this milestone, signaling its readiness for real-world use across the UK and Europe’s public and private healthcare organisations.

The new additions to Sanome’s strategic advisory board include:

• Former Health Minister and member of the House of Lords, Lord James Bethell
• Deputy Director NHS England of MedTech Innovation, Dr Arrash Yassaee
• Former Executive Director of NICE and Association of British Pharmaceutical Industry (ABPI), Prof Carole Longson

Who join leading expert advisors:

• Author of Big Brain Revolution: Artificial Intelligence – Spy or Saviour and AI expert, Dr Michelle Tempest
• Cambridge Angels Chair, Pam Garside
• Investment expert and IQVIA alumni, Dr Cem Baydar

Lord James Bethell said: “During my career, I’ve seen firsthand the pressure on our frontline services and how urgently we need smarter, faster tools to support clinical decisions and protect patients.

“What Sanome has built with MEMORI is more than just a breakthrough – it’s a transformative tool that allows clinicians to act sooner with more targeted interventions, saving lives, and reducing the pressures on an already burdened system.

“I’m proud to support a UK-grown solution that combines world-class science with a deep understanding of frontline healthcare. This is exactly the kind of innovation we need to build a more resilient, preventative NHS.”

Benedikt von Thüngen, Sanome Founder and CEO, added: “Achieving Class IIb certification is a major milestone in our journey and proves we can do that safely and at scale.

“The support of our expert advisory board, who have firsthand experience of what it takes to achieve the radical change needed across healthcare, further evidences Sanome’s role in helping to shape it, for the system and for the people whose lives are touched by it every single day.

“Together, we’re building the future of proactive, personalised care – one decision at a time.”

Sanome is actively working towards FDA approval and is already collaborating with NHS Trusts and technology providers on a variety of data-sharing initiatives.

The company is expected to announce additional UK, Europe and US partnerships and validation results later this year.