Pearl, the global leader in dental AI solutions, today announced that its Second Opinion® chairside dental pathology detection aid has been granted a certification recommendation as a Class IIa medical device under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR). The certification, issued by GMED SAS on June 6, 2023, makes Pearl the first company worldwide in the industry of AI-driven computer aided dental detection software to obtain the new European Medical Device Regulation (MDR) Certification recommendation.
The EU-MDR is the medical device regulation applied by the European Commission. It was established to set EU-wide rules to improve the safety and quality of medical devices and provide transparency for patients to ensure public health and patient safety. GMED SAS, an independent third-party certification organization based in France, conducted the technical documentation reviews and audits required for Second Opinion® MDR certification. This certification supersedes the EU Medical Devices Directive (MDD) certification, which Second Opinion® received in 2021.
“The EU-MDR is one of the world’s most robust health tech regulations, and it plays a vital role in ensuring medical devices meet the highest standards,” said Cambron Carter, co-founder and CTO of Pearl. “Our certification demonstrates the quality and care we apply in the development and maintenance of our AI systems and products, and is testament to our team’s dedication to delivering dental AI that exceeds the most exacting standards and best practices for healthcare technologies.”
Second Opinion uses computer vision and machine learning to assist dentists by automatically detecting a broad range of dental conditions in bitewing, periapical and panoramic radiographs of permanent teeth in patients 12 and older. To secure Class IIa classification, Pearl had to consistently demonstrate that its Second Opinion® solution and quality management system met the EU-MDR’s rigorous standards for safety and effectiveness. This involved undergoing external audits, submitting technical documentation, and supplying proof of clinical benefits and studies for review by GMED SAS.
“This is a major regulatory milestone for Pearl on the international stage,” said Ophir Tanz, founder and CEO of Pearl. “As we continue to lead the industry forward with advanced AI solutions for the global dental market, Second Opinion®’s EU-MDR certificate will reinforce the confidence of practices and providers across Europe who want to implement the most transformative new technology for patient care in dentistry.”
Although EU-MDR is only applicable in Europe, Pearl’s quality management system, as certified by GMED, is also compliant with several global standards to ensure medical software quality and safety, and has secured regulatory clearances for Second Opinion® in over 100 countries.
Dentists in Europe can begin using Pearl’s Second Opinion® today.
