NIA innovator TORTUS achieves Class IIa medical device status after years of clinical-led development
For NHS Innovation Accelerator (NIA) Innovator Dr Dominic Pimenta, the journey to this moment has taken years of clinical insight, collaboration and careful development.
TORTUS, the AI-powered clinical assistant founded by Dr Pimenta, has reached a significant milestone with its recognition as a Class IIa medical device. This is an important step in demonstrating that its technology has met the regulatory requirements needed to support safe use in healthcare.
The achievement marks a new chapter for TORTUS, but it is also the culmination of a much longer journey that began with a clinician identifying a challenge on the frontline and asking how technology could help.
“Looking back, it’s easy for people to see where we are today and assume the journey happened quickly. The reality is that it’s taken years of listening to clinicians, learning from every deployment and working closely with the NHS to build something that’s genuinely useful.”
“Looking back, it’s easy for people to see where we are today and assume the journey happened quickly. The reality is that it’s taken years of listening to clinicians, learning from every deployment and working closely with the NHS to build something that’s genuinely useful.”
From clinical challenge to regulated healthcare technology
As a cardiologist, Dr Pimenta experienced first-hand the pressures facing healthcare professionals, particularly the growing administrative burden that can take clinicians away from patient care.
This experience led him to explore how artificial intelligence could be used responsibly to support clinicians, reduce time spent on documentation and help healthcare teams focus more on patients.
“As a practising cardiologist, I experienced first-hand how much time administrative tasks take away from patient care. TORTUS was built to give that time back. Seeing clinicians use the technology in real NHS settings and hearing how it supports their day-to-day work is what makes all the effort worthwhile.”
“As a practising cardiologist, I experienced first-hand how much time administrative tasks take away from patient care. TORTUS was built to give that time back. Seeing clinicians use the technology in real NHS settings and hearing how it supports their day-to-day work is what makes all the effort worthwhile.”
Turning that vision into a regulated medical device required more than developing new technology. It involved building evidence, embedding clinical safety processes and ensuring that the solution could meet the standards required for use within healthcare.
The Class IIa medical device milestone reflects TORTUS’ commitment to developing AI that is not only innovative, but also safe, reliable and designed around the needs of clinicians.
Building trust in AI through evidence and regulation
The rapid growth of AI in healthcare has created enormous opportunities, but adoption depends on confidence from clinicians, patients and healthcare organisations.
For TORTUS, achieving Class IIa medical device status represents an important step in building that trust.
This approach aligns closely with the mission of the NIA, which supports innovators to generate evidence, navigate adoption challenges and scale solutions that can improve health and care.
As an NIA Innovator, Dr Pimenta is part of a community of healthcare entrepreneurs working to address some of the biggest challenges facing the NHS, while recognising that successful innovation requires close partnership with the health system.
“The NIA has been an important part of our journey. Jack Porter and the team have been tremendous advocates for TORTUS, by connecting us with NHS leaders, innovators and clinical teams who understand what it takes to adopt innovation safely and at scale.”
Dr Dominic Pimenta, CEO, TORTUS AI
A milestone towards wider NHS impact
The Class IIa medical device milestone represents an important moment in TORTUS’ journey, but the focus remains on supporting clinicians and improving healthcare delivery.
By reducing administrative workload and helping clinicians spend more time with patients, TORTUS aims to contribute to a more sustainable future for healthcare teams.
“This milestone isn’t the end of the journey, it’s another step. Our mission is to assist clinicians with their work and increase productivity in the NHS safely, while reducing burnout and improving morale. To do this we need to go into higher risk spaces and that’s why we’ve persevered and now created the highest possible bar for regulatory clinical AI in the UK in this space.”
“This milestone isn’t the end of the journey, it’s another step. Our mission is to assist clinicians with their work and increase productivity in the NHS safely, while reducing burnout and improving morale. To do this we need to go into higher risk spaces and that’s why we’ve persevered and now created the highest possible bar for regulatory clinical AI in the UK in this space.”
For Dr Pimenta and the TORTUS team, the achievement is a reminder that meaningful healthcare innovation takes time. Behind every breakthrough is a journey of listening, testing, learning and working alongside the people who will ultimately use the technology.
For more information about TORTUS please visit their innovation page and see their news coverage on their website.
