Years in the making.
For the moment that matters.
TORTUS is the first ambient voice technology to achieve UKCA Class IIa certification — raising the bar for clinical AI in the NHS.
Independently assessed. Not self-declared.
Class IIa places clinical AI in the same regulatory category as the medical equipment used directly in patient care. It isn’t a badge a manufacturer can grant itself — an independent UK Approved Body has to assess the full clinical, technical and safety evidence base, and audit the quality system behind it.
TORTUS is the first ambient voice technology to clear that bar under the UK’s own regulator, certified by Scarlet (UK Approved Body 8536). The certificate is explicit about the limits: TORTUS assists clinicians in the diagnostic pathway. It does not diagnose, recommend treatment or replace clinical judgement, and nothing it produces enters a patient’s record until a clinician has read and approved it.
The evidence behind the certificate.
Two multi-site NHS studies, tens of thousands of clinicians, and more than 2.5 million patient encounters of real deployment.
Sources: “Time to Care” (Wray, Mahdi et al., GOSH-led, SSRN 5350619) and “Unlocking Clinical Time in Emergency Departments” (Mahdi et al., SSRN 5350615). Both are non-peer-reviewed preprints.
“Class IIa creates a category that arrives pre-vetted — where independent due diligence has already been done to a depth no single bid evaluation could reach. It turns a difficult judgement into a clear standard a buyer can require.”
The foundation for what comes next.
TORTUS works inside the systems clinicians already use, rather than adding another screen alongside them. It runs within established electronic patient record platforms including Epic and Cerner, and reaches the point of care through partners such as X-on and Limbic. Trusts don’t have to replace what they already run to adopt it.
This certification matters beyond today, where AI drafts the notes, to tomorrow, where the same interface takes actions and summarises records autonomously. Class IIa moves AVT from a goal in itself to the foundation that unlocks what comes next.
FAQ.
Scope of certification: TORTUS is a UKCA Class IIa medical device under Part II of the Medical Devices Regulations 2002, certified by Scarlet (UK Approved Body 8536). Certificate SCAR-16.5.1.0, issued 24 June 2026.