AI-powered physiotherapy clinic Flok Health’s technology has been certified as a Class IIa Medical Device under EU Medical Device Regulations. The company says that this the first time in the UK or Europe that an AI system has been approved to deliver end-to-end diagnostic triage and treatment pathways autonomously, without human intervention.
The platform, which has been piloted by NHS Trusts in England and Scotland, provides NHS patients with same-day access to automated, responsive video appointments with an AI physiotherapist, delivered via a smartphone app.
Building on Flok Health’s previous Class I technology, the Class IIa clearance means its AI physiotherapist is now able to carry out diagnostic decisions.
The new clearance means that a patient’s entire care pathway – from initial assessment and diagnosis, through to treatment delivery and discharge – can be carried out autonomously by the AI physiotherapist without human-in-loop supervision.
This makes the technology radically more scalable than other digital triage solutions; which require clinician input, review and confirmation before clinical decisions can be made.
In addition to building on the capability of Flok’s existing digital back pain service, Class IIa clearance paves the way for the expansion of the technology to support a broader range of high-volume community pathways with further regulatory clearances: including the management of hip, knee, shoulder, and pelvic health conditions.
Finn Stevenson, CEO and co-founder at 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.
“With this certification, we hope to set a new benchmark for software medical devices delivering AI healthcare in Europe; and are proud to be the first to clear this bar.”
In a recent pilot with Cambridgeshire Community Services NHS Trust, Flok’s AI clinic more than halved waiting lists for back pain and reduced waiting times for all MSK conditions by 44% in less than ten weeks, treating over 2500 back pain referrals.
After using Flok Health, 8 in 10 (80%) patients in Cambridgeshire reported that their experience with Flok had been “equivalent or better” than traditional face-to-face physiotherapy.
The service was also piloted by NHS Lothian in Scotland earlier this year.
According to the NHS website, over 30 million working days are lost to MSK conditions like back pain every year in the UK, with MSK problems accounting for up to 30% of GP appointments.
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