Finn Stevenson, co-founder and chief executive, Flok Health (Credit: Flok Health)
Exclusive: An AI-powered physiotherapy clinic has secured Class IIa Medical Device approval under EU regulations, meaning that it can carry out diagnostic decisions without human supervision.
The platform from Flok Health, which provides same-day video appointments for back pain via an app, has been piloted by NHS trusts in England and Scotland.
According to Flok Health, it is the first time in the UK or Europe that an AI system has been approved to autonomously deliver end-to-end diagnostic triage and treatment pathways without requiring input from a clinician.
Finn Stevenson, chief executive and co-founder of Flok Health, said: “The healthcare needs of our population are rapidly outgrowing what is possible for a traditional clinical workforce to manage.
“Autonomous care is the only viable way to solve this problem at scale, so we’re delighted to be the first healthcare provider in Europe to gain regulatory clearance to deliver fully autonomous AI care to patients.
“This clearance is testament to the importance of working with regulators and existing regulatory frameworks to bring AI care models to market.
“Medical device certification is not just a legal requirement, it’s a valuable way to demonstrate that our service has met the highest standard for safety and clinical performance.”
Building on Flok Health’s previous Class I technology, the Class IIa clearance means that its AI physiotherapist is now able to carry out diagnostic decisions and can carry out a patient’s entire care pathway – from initial assessment and diagnosis through to treatment and eventual discharge without human supervision.
As a result, the technology is more scalable than other digital triage solutions, which require clinician input, review and confirmation before clinical decisions can be made.
It also supports the potential for expansion of the technology to support a wider range of community pathways, including the management of hip, knee, shoulder and pelvic health conditions, with further regulatory clearances.
A pilot of Flok Health’s platform, at Cambridgeshire Community Services NHS Trust, carried out over a 12-week period between February 2025 and June 2025, found the technology more than halved waiting lists for back pain and reduced waiting times for all musculoskeletal conditions by 44%.
The AI tool evaluates a patient’s symptoms to determine whether the AI clinic is capable of safely providing the right treatment.
If approved for digital treatment, the patient will have access to weekly video appointments with the AI physiotherapist.
Patients presenting with more complex symptoms receive an additional assessment with a member of Flok’s clinical team, where they will either be approved for digital treatment or triaged to a more suitable alternative NHS service.
Meanwhile, a new national commission, which includes experts from big tech companies, leading clinicians, researchers and patient advocates, has been set up to advise the Medicines and Healthcare products Regulatory Agency (MHRA) on speeding up access to the latest AI tools.
Speaking at the AI in Health Summit on 1 October, Lawrence Tallon, chief executive of the MHRA, said that “we cannot afford to wait years” for AI to be regulated at the pace of innovation.
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