Key Takeaways
- Flok Health’s AI-driven physiotherapy platform has received Class IIa Medical Device approval in the EU, enabling autonomous decision-making.
- The system can handle the entire treatment pathway without human oversight, significantly reducing patient waiting times.
- A new national commission aims to expedite access to AI healthcare tools, highlighting the need for rapid regulatory adaptation.
AI-Powered Physiotherapy Revolutionizes Patient Care
Flok Health has achieved a significant milestone by securing Class IIa Medical Device approval under EU regulations, marking a groundbreaking advancement in healthcare technology. This approval allows the company’s AI-powered physiotherapy platform to autonomously perform diagnostic assessments and provide treatment without the need for human intervention.
The platform focuses primarily on back pain management and offers same-day video consultations through an app. Notably, this is the first instance in the UK and Europe where an AI system is authorized to deliver comprehensive diagnostic and treatment pathways independently of a clinician.
Finn Stevenson, the co-founder and CEO of Flok Health, emphasized the urgent need for innovative healthcare solutions as traditional clinical resources struggle to meet demand. “Autonomous care is the only viable way to solve this problem at scale,” he stated, expressing pride in being the first healthcare provider in Europe to achieve such regulatory clearance. He remarked on the importance of collaboration with regulators to ensure that AI models meet safety and performance standards.
The Class IIa designation builds upon Flok Health’s previous Class I technology, broadening the AI physiotherapist’s capabilities to execute the entire care process—from initial diagnosis through treatment to discharge—without any clinical oversight. This significant enhancement makes the technology more adaptable compared to other digital triage systems, which still require clinician input and confirmation.
Clinical trials have previously demonstrated the platform’s effectiveness. A pilot program conducted by the Cambridgeshire Community Services NHS Trust between February and June 2025 revealed that the AI tool reduced waiting lists for back pain treatment by more than half and decreased waiting times for all musculoskeletal conditions by 44%. The AI evaluates patient symptoms to determine appropriate treatment plans and facilitates ongoing weekly video consultations for eligible patients. For cases involving more complex symptoms, Flok’s clinical team provides additional assessments to determine the best course of action.
In response to the rapid advancements in AI within healthcare, a new national commission has been established. Comprised of experts from major tech companies, leading medical professionals, researchers, and patient advocates, this group will advise the Medicines and Healthcare products Regulatory Agency (MHRA) on the urgent need to fast-track access to innovative AI tools. At the recent AI in Health Summit, Lawrence Tallon, CEO of MHRA, stressed that “we cannot afford to wait years” for AI regulations to keep up with technological advancements.
The combination of Flok Health’s cutting-edge AI platform and the proactive measures by regulatory bodies underscores a transformative shift in healthcare delivery, promoting the potential for more accessible and efficient patient care solutions.
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