Visiba Group (‘Visiba’), one of the leading Healthtech companies in the Nordics, today announces that Red Robin, the engine that powers Visiba Triage, has been CE-marked as a Class IIa medical device under the Medical Devices Regulation (EU) 2017/745.
Visiba is believed to be one of just a few companies globally to achieve this important certification for an AI-triage solution. Red Robin uses a Bayesian Neural Network (BNN) that incorporates probabilistic reasoning. In healthcare triage, this type of model is believed to be ‘next generation’ when compared to traditional branch and tree models, some of which have been around for over 20 years.
Visiba Triage enables patients to be assessed digitally via a dynamic chat, the outputs of which can be used by healthcare providers to aid clinical decision-making and triage. The result is a dynamic patient navigation solution that enables healthcare providers to equip patients to find the right care, for the right person at the right time.
EU MDR is one of the world’s most stringent medical device regulations and demonstrates that companies meet rigorous safety and quality standards. Whilst Class I requires self-certification, the much stricter Class IIa requires companies to prove compliance against multiple criteria to external notifying bodies (in this case the British Standards Institution - BSI). Criteria cover technical, clinical and AI strands and Visiba are thought to be one of the first companies of its kind to be assessed against the AI strand.
Katherine Leung, Visiba Triage Clinical Product Owner and GP said:
”The EU MDR process was extremely rigorous, with several rounds of auditing of our Quality Management System (QMS) and deep dives into our clinical evaluation files, post-market surveillance and risk management processes. Achieving certification is a testament to our on-going commitment to the highest levels of safety, quality and transparency.”
One of the features of Red Robin is the ‘clinical feedback loop’ that enables clinicians using the solution to feedback on individual cases. This data is then used to continually refine the accuracy of the model with almost 200,000 real-world cases used to date.
Visiba CEO Johan Gustafsson said:
“Achieving Class IIa MDR CE-marking is a major milestone that substantiates our focus on safety and quality. To be one of the few companies globally to achieve this certification for an AI triage solution is a great accolade. AI offers great scope to help create efficiencies in healthcare, but this must be counter-balanced by careful risk assessment when selecting solutions. Healthcare providers should be looking for partners with Class IIa CE-marking as a bare minimum.”
Visiba has helped healthcare providers digitally transform how they deliver care since 2014. Today they stand at the forefront of powerful AI-enabled triage.
Headquartered in Gothenburg, Sweden, Visiba is deployed in public and private healthcare in Sweden, Norway, Finland and the UK.
Red Robin is the CE-marked registered medical device that powers Visiba Triage. Red Robin uses a probabilistic Bayesian Neural Network to dynamically link clinical symptoms and diagnoses to assess patients digitally. The outputs are used to assist clinicians in triaging patients via a summary of patient questions, answers, and images, along with most likely diagnosis and urgency of the patient case.
For more information and interviews please contact:
Åsa Söderlund, Marketing Manager
Asa.soderlund@visibagroup.com
0046 702-723202