Sanome’s MEMORI becomes the first UK-developed AI medical device to gain Class 2b certification, signalling a major step forward for preventative healthcare.

An AI platform that can detect hospital-acquired infections (HAIs) up to three days earlier than current tools has received UK regulatory approval – and attracted heavyweight backing from senior healthcare leaders including former UK Health Minister Lord James Bethell.

London-based healthtech company Sanome has announced that its platform, MEMORI, has achieved the tough Class IIb CE certification and MHRA approval, clearing the way for NHS rollout and future FDA approval.

HAIs are a costly and persistent problem across global healthcare systems. In the UK alone, they are estimated to cost the NHS around £2.7 billion every year, accounting for 7 million lost bed days annually. Across Europe and the US, the combined burden runs into tens of billions.

MEMORI aims to tackle that by analysing live patient data – from vital signs to clinicians’ notes – and providing real-time, explainable alerts directly into hospital workflows. By spotting early warning signs up to 72 hours before traditional methods, clinicians can intervene sooner, improving outcomes while reducing costs and pressures on already overstretched hospitals.

A UK-built milestone

Achieving Class 2b certification is significant. It is one of the most stringent categories for medical software, covering tools that directly support diagnosis or clinical management. MEMORI is the first UK-built AI system to reach this level, marking it as ready for clinical use at scale across the NHS and beyond.

Sanome’s co-founder and CEO, Benedikt von Thüngen, said the technology is rooted in personal experience:

“My father died in hospital because early warning signs were missed. We didn’t set out to build just another AI tool – we set out to create something that means no one else has to experience what I did. MEMORI gives clinicians a window into the future, enabling them to act before it’s too late.”

Backed by senior figures

The achievement has drawn in a panel of strategic advisors including Lord James Bethell, Prof Carole Longson (former NICE executive), and Dr Arrash Yassaee (NHS England’s Deputy Director of MedTech Innovation).

Lord Bethell said: “I’ve seen firsthand how critical early detection is – sometimes it’s the difference between life and death. MEMORI is more than just a breakthrough; it’s a transformative tool that allows clinicians to act sooner, with targeted interventions, saving lives and reducing the strain on frontline services.”

Looking ahead

Sanome is already working with NHS Trusts and technology partners on real-world validation and is preparing for FDA submission to open doors in the US. Additional UK, European and US partnerships are expected later this year.

With the NHS’s 10-Year Plan placing heavy emphasis on prevention and early intervention, MEMORI arrives at a critical moment for healthcare innovation. If the technology delivers at scale, it could represent a major shift in how hospitals worldwide approach infection management – from reactive treatment to proactive prevention.