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Canadian MedTech company FluidAI approves clinical trial in the UK

4th April 2024

Fluid AI is a Canadian MedTech company that uses data and AI to develop tools for better postoperative care.

The company has developed a hardware sensor that connects to the abdomen and monitors the patient’s PH level after surgery to identify any leaks. With the sensor, any leak can be identified within two days whereas existing measures identify them in nine days.

Fluid AI joined five SMEs in our third international Propel@YH Boot Camp. Run by Health Innovation Yorkshire & Humber, the Boot Camp seeks to bring the best health innovations from around the world into the UK, with the Yorkshire and Humber region being the first to make use of them.

Why the UK?

The UK healthcare system is more in line with the Canadian healthcare system and the UK market is reputable. It’s got very high standards and is seen as the benchmark and badge of approval, whilst also be a stepping stone into Europe.

How did the Propel@YH Boot Camp programme help?

The Boot Camp helped in three key areas:

  • Understanding the UK healthcare market
  • Understanding the regulatory changes to medical devices
  • Connections as a direct result of the programme. Fluid AI developed a relationship with a surgeon at Leeds Teaching Hospitals Trust who is undertaking a clinical trial.

The company joined the programme to develop the most up-to-date understanding of the UK healthcare system, and to identify potential partners that can support them in expanding their market activities into the UK. Post-Brexit, the UK has undergone significant reform to its regulatory processes, and a lot of the regulatory roadmap is still being developed in real-time. Knowing this, Fluid AI sought a programme that would put them in direct contact with stakeholders at these regulatory bodies, as well as NHS trusts, surgeons, etc. who would have the latest understanding of these changes and could give specific advice on how to navigate these issues as a medical device company that is already Health Canada approved. Finally, Fluid AI saw the UK as an entry point for the rest of continental Europe. The UK is a well-respected healthcare market and success there would echo world-wide.

Along with other participants, the programme provided the company with five days of intensive support through a range of masterclasses, workshops and networking events, helping to develop their understanding of NHS government, finance and procurement frameworks, and clinical safety and supplier regulations. The programme also introduced them to key stakeholders, connecting them with the right support to evaluate the value of their technology and suitability for the UK market.

What was the most useful part of the programme?

The connections proved invaluable and the expertise in different areas such as legal, finance and understanding the NHS was really useful.  Everyone was extremely helpful and friendly.

What next?

Fluid AI has just approved the clinical trial protocol for a 50 patient/device study in the UK. This was specifically as a result of the programme, as some of the organisers/speakers connected the company to their surgical colleagues. This is a major milestone, and it is anticipated that the study will pave the way for a UK market entry, as well as a 30-centre study throughout Europe.

Youssef Helwa, CEO of FluidAI Medical Said:

“The UK market represents a critical junction for advancing medical technology, and our AI-driven postoperative monitor promises to significantly enhance patient outcomes in the country. By accurately tracking the recovery progress, we aim to reduce hospital readmissions and provide peace of mind for patients and healthcare providers alike. The Propel@YH was instrumental, offering us insights into market intricacies and regulatory frameworks, while also fostering clinical trial relationships that propel our mission forward.” –