Gothenburg-based Boneprox has received EU MDR Class IIa certification for Umbra, their AI tool for detecting and classifying caries on dental X-rays. Boneprox is the first Nordic manufacturer to achieve this level.
“AI only belongs in the clinic if clinicians can trust it. That is why we chose the demanding route of independent assessment of our clinical evidence, quality system and the claims we make. The dentist remains in control, while Umbra provides an additional, independently assessed layer of support,” says Peder Remman, CEO and co-founder of Boneprox.
The AI technology has been evaluated in a peer-reviewed study published in BMC Oral Health. Researchers trained and evaluated deep-learning models using more than 13,000 bitewing X-rays annotated by dental clinicians.
This certification enables Boneprox to offer Umbra to dental clinics, partners and public dental services across the EU and EEA. Boneprox is also developing additional areas of dental analysis that the company intends to take through the same regulatory process.
“Class IIa certification is not a one-time event. It means ongoing surveillance, post-market monitoring and full traceability. That is the standard we hold ourselves to, and the standard clinics should expect from AI used to support clinical decisions,” says Mikkel Lager, Compliance Manager at Boneprox.
Boneprox has a long-standing connection to Sahlgrenska Science Park. The company joined Sahlgrenska Science Park’s accelerator activities in 2019 and went on to win the HealthTech Award in 2021 for its use of AI and dental X-rays to identify health risks.
Today, the company has more than 7,000 users and continues to develop clinical intelligence for dentistry from Gothenburg.
Link to website: Boneprox
