Medical Device News Magazine

Pearl Receives Industry-First EU-MDR Certification for Second Opinion AI Platform

Pearl’s flagship solution becomes the first and only AI-based dental pathology detection software to be certified as a Class IIa medical device under EU-MDR

About Medical Device News Magazine

About Medical Device News Magazine. We are a digital publication founded in 2008 located in the United States.

Advertise with Medical Device News Magazine! Join Our #1 Family of Advertisers!

We pride ourselves on being the best-kept secret when it comes to distributing your news! Our unique digital approach enables us to circulate your...

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.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Other News

HeartFlow Introduces Next Generation Interactive Plaque Analysis Platform to Assess Patient Risk in Suspected Coronary Artery Disease

The HeartFlow Plaque Analysis uses proprietary algorithms to analyze coronary CT angiogram (CCTA) scans, creating a personalized 3D model that quantifies and characterizes plaque volume in the coronary arteries, aiding risk assessment of coronary artery disease. The technology was introduced at the Society of Cardiovascular Computed Tomography (SCCT) Annual Scientific Meeting in Washington, D.C.

Ultrahuman Announces its App Store ‘PowerPlugs’ with the World’s First AFib Detection Technology on a Smart Ring

Recognizing each individual’s health journey is unique, PowerPlugs enable people to choose and focus on the aspects of their health that matter most. It’s designed for highly personalized health insights, ensuring that every individual can personalize their health tracking to their unique needs and goals.

VisionAir Solutions Celebrates Milestone and New Collaboration

This achievement marks VisionAir Solutions commitment to bringing technological innovation to pulmonary medicine. Since its acquisition by Theken Companies last year, VAS has over doubled its growth and continues to demonstrate industry adoption and the advantages of personalized healthcare.