Latest news with #OphirTanz
Yahoo
27-05-2025
- Business
- Yahoo
Pearl Becomes First Dental AI Company Cleared by FDA for Both 2D and 3D Imaging
Second Opinion® 3D expands Pearl's industry-leading AI capabilities to CBCT imaging—solidifying its position as the most advanced dental AI platform in the world LOS ANGELES, May 27, 2025--(BUSINESS WIRE)--Pearl, the global leader in dental AI solutions, today announced that it has received FDA 510(k) clearance for Second Opinion® 3D, making Pearl the first and only dental AI company with FDA-cleared solutions for both 2D and 3D dental radiologic image analysis. With this new clearance, Pearl's Second Opinion® platform extends its AI capabilities to cone beam computed tomography (CBCT) imaging, enabling automated identification of critical anatomical structures—including dentition, maxilla, mandible, inferior alveolar canal and mental foramen (IAN), maxillary sinus, nasal space, and airway—in 3D scans. "Pearl's mission has always been to deliver the most advanced and clinically trusted AI solutions in dentistry," said Ophir Tanz, founder and CEO of Pearl. "Becoming the first company to achieve FDA clearance for both 2D and 3D radiologic analysis isn't just a milestone for us—it's a milestone for dentistry." Second Opinion® 3D is designed to assist dental professionals in reviewing CBCT scans with greater speed, accuracy, and clarity. It empowers clinicians with instant AI-powered visualizations that support more precise diagnostics and treatment planning across specialties, including implantology, orthodontics, oral surgery, and airway management. The FDA clearance follows extensive bench performance testing, in which Second Opinion® 3D demonstrated high segmentation accuracy across all targeted anatomical structures. Dice Similarity Coefficient scores exceeded clinical thresholds for every category, confirming both safety and effectiveness. This clearance builds on Pearl's track record as a regulatory leader in dental AI. The company's original Second Opinion® platform remains the most widely deployed FDA-cleared solution for chairside AI pathology detection in 2D radiographs. With the addition of 3D capabilities, Pearl now delivers the only FDA-cleared platform capable of supporting comprehensive radiologic review across both major dental imaging modalities. About Pearl Pearl is an AI-driven company committed to enhancing patient care in dentistry. Founded in 2019 by a team with decades of experience developing successful, enterprise-grade computer vision solutions, Pearl introduced the first-ever FDA-cleared AI capable of reading and instantly identifying diseases in dental x-rays. With regulatory clearance in 120 countries, Pearl's AI assists dentists in making precise clinical decisions and effectively communicating with patients, thereby transforming the dental care experience worldwide. As dentistry's global AI leader, Pearl is committed to the ongoing innovation of robust, accessible AI tools that improve patient health outcomes and build greater trust in dental medicine. To request a demo, please visit View source version on Contacts Media Contact Kate Gundrypearl@ 617-797-5174 Sign in to access your portfolio
Business Wire
27-05-2025
- Business
- Business Wire
Pearl Becomes First Dental AI Company Cleared by FDA for Both 2D and 3D Imaging
LOS ANGELES--(BUSINESS WIRE)-- Pearl, the global leader in dental AI solutions, today announced that it has received FDA 510(k) clearance for Second Opinion® 3D, making Pearl the first and only dental AI company with FDA-cleared solutions for both 2D and 3D dental radiologic image analysis. With this new clearance, Pearl's Second Opinion® platform extends its AI capabilities to cone beam computed tomography (CBCT) imaging, enabling automated identification of critical anatomical structures—including dentition, maxilla, mandible, inferior alveolar canal and mental foramen (IAN), maxillary sinus, nasal space, and airway—in 3D scans. 'Pearl's mission has always been to deliver the most advanced and clinically trusted AI solutions in dentistry,' said Ophir Tanz, founder and CEO of Pearl. 'Becoming the first company to achieve FDA clearance for both 2D and 3D radiologic analysis isn't just a milestone for us—it's a milestone for dentistry.' Second Opinion® 3D is designed to assist dental professionals in reviewing CBCT scans with greater speed, accuracy, and clarity. It empowers clinicians with instant AI-powered visualizations that support more precise diagnostics and treatment planning across specialties, including implantology, orthodontics, oral surgery, and airway management. The FDA clearance follows extensive bench performance testing, in which Second Opinion® 3D demonstrated high segmentation accuracy across all targeted anatomical structures. Dice Similarity Coefficient scores exceeded clinical thresholds for every category, confirming both safety and effectiveness. This clearance builds on Pearl's track record as a regulatory leader in dental AI. The company's original Second Opinion® platform remains the most widely deployed FDA-cleared solution for chairside AI pathology detection in 2D radiographs. With the addition of 3D capabilities, Pearl now delivers the only FDA-cleared platform capable of supporting comprehensive radiologic review across both major dental imaging modalities. About Pearl Pearl is an AI-driven company committed to enhancing patient care in dentistry. Founded in 2019 by a team with decades of experience developing successful, enterprise-grade computer vision solutions, Pearl introduced the first-ever FDA-cleared AI capable of reading and instantly identifying diseases in dental x-rays. With regulatory clearance in 120 countries, Pearl's AI assists dentists in making precise clinical decisions and effectively communicating with patients, thereby transforming the dental care experience worldwide. As dentistry's global AI leader, Pearl is committed to the ongoing innovation of robust, accessible AI tools that improve patient health outcomes and build greater trust in dental medicine. To request a demo, please visit
Business Wire
14-05-2025
- Business
- Business Wire
Pearl Announces Global Collaboration with vVARDIS to Transform Early Detection and Proactive Treatment of Early Dental Decay
LOS ANGELES--(BUSINESS WIRE)-- Pearl, the global leader in dental AI solutions, today announced a collaboration with vVARDIS, a leader in innovative dental care products, to educate dental professionals about detecting and treating early stages of dental decay. The global collaboration brings together vVARDIS, which has biomimetic, drill-free early caries treatment products, Curodont™, and Pearl, which has an AI-powered real-time radiologic detection aid, Second Opinion, to deliver the message of advanced, non-invasive solutions for treating early dental decay. Pearl's AI solutions enable dental providers to accurately detect conditions such as decay or cavities at their earliest stages, ensuring a proactive approach to oral health. Beyond early condition detection, Pearl also builds patient trust by enhancing their understanding of dental imagery, leading to higher patient acceptance and more informed treatment decisions. vVARDIS' Curodont™ offers a drill-free brush-on solution to aid hydroxyapatite formation throughout the early decay, helping patients to preserve the natural tooth structure and helping to avoid invasive and costly fillings. Up to 80% of all patients have tooth decay in early stages 1. Curodont™ gives dental professionals the opportunity to treat these patients with a simple and fast topical application during the same visit it's detected, without the need for a new appointment. 'At Pearl, we are dedicated to enhancing and standardizing dental diagnostics by leveraging AI to simplify radiograph interpretation and improve patient communication,' said Ophir Tanz, CEO and founder of Pearl. 'Our collaboration with vVARDIS enables a comprehensive, internationally scalable approach to early intervention against dental decay, giving patients more options for an effective and proactive path to improved oral health.' 'Partnering with Pearl is a natural progression in our mission to provide innovative solutions for early stage dental decay,' said Jeremy Thomas, President, vVARDIS North America. 'This collaboration equips global dental professionals with modern tools to detect conditions sooner and provides a proven, non-invasive solution to help restore enamel health.' 'As both dentists and entrepreneurs, we are thrilled to finally have and offer a groundbreaking approach to treating early decay,' said Drs. Haley and Goly Abivardi, DMDs, Founders and Co-CEOs of vVARDIS. '34 million school hours are lost each year due to emergency dental care 2 and $45 billion in lost productivity annually from untreated oral disease in the United States 3,4. Dental professionals have been waiting for decades for a drill-free treatment that addresses the sub-clinical signs of caries in the same visit. With its seamless integration into existing workflows, we believe that Curodont™ has the potential to rapidly become the new standard of care for the treatment of early caries, broadening the scope of services offered and empowering dentists and hygienists to lead the way in the management of early caries, ultimately enhancing patient care.' About Pearl Pearl is an AI-driven company committed to enhancing patient care in dentistry. Founded in 2019 by a team with decades of experience developing successful, enterprise-grade computer vision solutions, Pearl introduced the first-ever FDA-cleared AI capable of reading and instantly identifying diseases in dental x-rays. With regulatory clearance in 120 countries, Pearl's AI assists dentists in making precise clinical decisions and effectively communicating with patients, thereby transforming the dental care experience worldwide. As dentistry's global AI leader, Pearl is committed to the ongoing innovation of robust, accessible AI tools that improve patient health outcomes and build greater trust in dental medicine. To request a demo, please visit About vVARDIS vVARDIS is an innovative Swiss healthcare company located in Zug, Switzerland that offers groundbreaking biomimetic, non-invasive solutions for dental professionals under the Curodont™ brand. Founded by Swiss dentists, innovators and awarded entrepreneurs, Dr. Haley Abivardi, DMD and Dr. Goly Abivardi, DMD, vVARDIS is the result of more than 25 years of research, paired with the commitment of its founders to make an impact on people's lives, including the underserved. vVARDIS' mission is to expand access to novel approaches to the standard of care in dentistry with the purpose of improving oral health – the foundation for overall health. vVARDIS science is backed by 25 years of research and more than 200 scientific publications, including meta-analysis, peer-reviewed clinical studies and a long-term peer-reviewed real-world evidence study, with hundreds of thousands of patients being treated successfully. For more information, visit vVARDIS at and
Business Wire
13-05-2025
- Business
- Business Wire
Top Dental School Receives ADEA Grant to Use Pearl's AI Platform to Improve Radiologic Education and Clinical Performance for High-Quality, Consistent Patient Care
LOS ANGELES--(BUSINESS WIRE)-- Pearl, the global leader in dental AI solutions, today announced that the University of California, Los Angeles (UCLA) School of Dentistry has been awarded a grant from the American Dental Education Association (ADEA) to integrate Pearl Calibrate, the first AI-powered clinical calibration tool, into its educational and research programs. The grant-powered collaboration will enable faculty, residents, and students to incorporate advanced AI technology into their curriculum and in preparation for clinical work. Insights garnered from the implementation are expected later this year. The integration of Calibrate into dental training infrastructure marks a pivotal moment in dental education, highlighting a collective commitment to adopting innovative solutions that enhance both teaching and patient care. 'It is terrific to see UCLA taking a leading role in the AI-driven advancement of dental education,' said Ophir Tanz, founder and CEO of Pearl. 'The ADEA grant empowers faculty and students with a tool designed specifically to foster consistency and higher standards in radiologic diagnosis –– and underscores AI's increasingly vital influence on dentistry today. In collaboration with UCLA, we are making significant strides toward a dental future where AI and human talent blend to elevate care and foster better outcomes for patients.' 'At UCLA, we are committed to embracing innovation that safely and securely advances our field,' said Dr. Paul H. Krebsbach, Dean of the UCLA School of Dentistry. 'Implementing this new technology aligns with our strategic imperative to leverage best-in-class digital architecture and to prepare our students to lead in the evolving landscape of dental care. I commend Dr. Sanjay Mallya, chair of our Section of Oral and Maxillofacial Radiology, for leading this initiative.' Calibrate is a multi-purpose tool that helps a broad range of users hone their dental x-ray evaluation skills and overcome subjectivity endemic to diagnostic radiology. Calibrate helps ensure consistency across clinical professionals operating within dental industry organizations including universities, single- and multi-site clinics, radiology centers, and insurance companies. Offering an extensive internal image library, as well as the ability to upload image datasets, Calibrate allows administrators to prescribe interpretive standards and customize benchmarks tailored to their organizations' unique clinical specifications. About Pearl Pearl is an AI-driven company committed to enhancing patient care in dentistry. Founded in 2019 by a team with decades of experience developing successful, enterprise-grade computer vision solutions, Pearl introduced the first-ever FDA-cleared AI capable of reading and instantly identifying diseases in dental x-rays. With regulatory clearance in 120 countries, Pearl's AI assists dentists in making precise clinical decisions and effectively communicating with patients, thereby transforming the dental care experience worldwide. As dentistry's global AI leader, Pearl is committed to the ongoing innovation of robust, accessible AI tools that improve patient health outcomes and build greater trust in dental medicine. To request a demo, please visit
