Latest news with #SecondOpinion®
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
20-05-2025
- Business
- Business Wire
Pearl Powers AI Transformation Across Partnerships for Dentists' Expansive Practice Network
LOS ANGELES--(BUSINESS WIRE)-- Pearl, the global leader in dental AI solutions, and Partnerships for Dentists ('P4D'), a leading dental support organization serving practices across the United States, today announced some of the results of the years-long partnership that brings Pearl's powerful dental AI technology to P4D's multi-state network of dental practices. The integration is live across three different imaging systems in use by P4D, demonstrating the seamless compatibility of Pearl's platform with leading imaging technologies on the market. 'Partnering with Pearl has been transformational for our providers and the patients they serve,' said Dr. Greg Kerbel, Chief Clinical Officer at Partnerships for Dentists. 'By integrating Second Opinion® across our imaging systems, we've equipped our dentists with state-of-the-art AI that sharpens diagnostic accuracy, boosts efficiency, and elevates confidence. In just months, we've seen a 35% increase in newly identified dentistry and uncovered nearly $30 million in previously untreated patient needs. This partnership strengthens our commitment to providing exceptional, modern care at every practice in our network.' Pearl's Second Opinion® software is the first-and-only AI radiologic aid cleared for use in over 120 countries. Purpose-built for the realities of modern dental practice—whether in small family-run offices or expansive DSOs—Pearl's platform integrates seamlessly with existing imaging software to deliver real-time AI findings that support accurate diagnosis, drive case acceptance, and enhance patient communication. With tools like visual tooth-part mapping and vibrant pathology indicators, Second Opinion® is designed to make oral health more understandable for patients and more actionable for providers. 'P4D empowers practices to grow independently by giving dentists access to tools they can rely on,' said McKenzie Fagan, Vice President of DSO Sales at Pearl. 'We're proud to partner with P4D to deliver real-time AI insights without disrupting their imaging workflows, and to help their providers do what they do best: deliver great patient care with confidence and consistency.' P4D's integration of Pearl's AI platform has already delivered measurable results. Practices using Pearl saw a 35% increase in newly identified dentistry and a 44% boost in newly diagnosed procedures. Through Pearl's Practice Intelligence®, automated chart audits surfaced nearly $30 million in previously untreated patient needs that have since been acted on, unlocking growth for P4D practices and better health outcomes for patients. 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 Partnerships for Dentists Partnerships for Dentists (P4D) is a Dental Support Organization (DSO) committed to enhancing the business side of dental practices, allowing clinicians to focus on delivering exceptional patient care. With a foundation built on servant leadership, P4D offers a comprehensive suite of non-clinical services, including operations management, marketing, human resources, accounting, and IT support. Their partnership model empowers dentists to retain clinical autonomy while benefiting from strategic support aimed at maximizing practice growth and long-term wealth creation. On average, affiliated practices experience a 30% increase in EBITDA within the first year of partnership. P4D is headquartered in Plano, Texas, and serves dental practices nationwide.
