Align Technology Launches Align X-ray Insights, an AI Computer-Aided Detection Software, in the European Union and United Kingdom
Align Technology (NASDAQ: ALGN) has launched Align X-ray Insights, an AI-powered computer-aided detection software, in the EU and UK. The solution, which automatically analyzes 2D radiographs, will be showcased at the 2025 IDS Dental Show in Cologne.
The software, part of the Align Digital Platform, helps doctors diagnose dental and oral health conditions through AI detection of caries, periapical radiolucencies, and periodontal bone loss. Early user surveys showed 95% of doctors found it helpful in communicating oral health conditions, while 91% reported improved patient trust and treatment acceptance.
The desktop/tablet version will be available from March 25, 2025, with iTero scanner integration planned for release. The software has received regulatory clearance in Europe, UK, Canada, and New Zealand, with pending approvals in other markets including US FDA 510K clearance. A 60-day free trial is being offered as part of the launch.
Align Technology (NASDAQ: ALGN) ha lanciato Align X-ray Insights, un software di rilevamento assistito da computer alimentato da intelligenza artificiale, nell'UE e nel Regno Unito. La soluzione, che analizza automaticamente le radiografie 2D, sarà presentata al 2025 IDS Dental Show a Colonia.
Il software, parte della Align Digital Platform, aiuta i medici a diagnosticare condizioni di salute dentale e orale attraverso il rilevamento AI di carie, radiolucenze periapicali e perdita ossea parodontale. I primi sondaggi tra gli utenti hanno mostrato che il 95% dei medici lo ha trovato utile per comunicare le condizioni di salute orale, mentre il 91% ha riportato un miglioramento della fiducia dei pazienti e dell'accettazione del trattamento.
La versione desktop/tablet sarà disponibile dal 25 marzo 2025, con integrazione dello scanner iTero prevista per il rilascio. Il software ha ricevuto l'approvazione normativa in Europa, Regno Unito, Canada e Nuova Zelanda, con approvazioni in attesa in altri mercati, compresa l'approvazione FDA 510K negli Stati Uniti. È offerta una prova gratuita di 60 giorni come parte del lancio.
Align Technology (NASDAQ: ALGN) ha lanzado Align X-ray Insights, un software de detección asistida por computadora impulsado por inteligencia artificial, en la UE y el Reino Unido. La solución, que analiza automáticamente radiografías 2D, se presentará en el 2025 IDS Dental Show en Colonia.
El software, parte de la Align Digital Platform, ayuda a los médicos a diagnosticar condiciones de salud dental y oral a través de la detección de caries, radiolucencias periapicales y pérdida ósea periodontal mediante IA. Las primeras encuestas entre usuarios mostraron que el 95% de los médicos lo consideraron útil para comunicar condiciones de salud oral, mientras que el 91% informó una mejora en la confianza de los pacientes y en la aceptación del tratamiento.
La versión de escritorio/tableta estará disponible a partir del 25 de marzo de 2025, con integración del escáner iTero prevista para su lanzamiento. El software ha recibido la aprobación regulatoria en Europa, Reino Unido, Canadá y Nueva Zelanda, con aprobaciones pendientes en otros mercados, incluida la aprobación del FDA 510K en EE. UU. Se ofrece una prueba gratuita de 60 días como parte del lanzamiento.
Align Technology (NASDAQ: ALGN)는 EU와 영국에서 인공지능 기반의 컴퓨터 지원 탐지 소프트웨어인 Align X-ray Insights를 출시했습니다. 이 솔루션은 2D 방사선 사진을 자동으로 분석하며, 2025 IDS Dental Show에서 쾰른에서 선보일 예정입니다.
이 소프트웨어는 Align Digital Platform의 일환으로, 의사들이 충치, 치근 주위 투명도 및 치주 뼈 손실을 AI로 탐지하여 치과 및 구강 건강 상태를 진단하는 데 도움을 줍니다. 초기 사용자 설문 조사에 따르면, 95%의 의사가 구강 건강 상태를 전달하는 데 유용하다고 보고했으며, 91%는 환자의 신뢰와 치료 수용이 향상되었다고 응답했습니다.
데스크탑/태블릿 버전은 2025년 3월 25일부터 이용 가능하며, iTero 스캐너 통합이 예정되어 있습니다. 이 소프트웨어는 유럽, 영국, 캐나다 및 뉴질랜드에서 규제 승인을 받았으며, 미국 FDA 510K 승인을 포함한 다른 시장에서도 승인을 기다리고 있습니다. 출시의 일환으로 60일 무료 체험이 제공됩니다.
Align Technology (NASDAQ: ALGN) a lancé Align X-ray Insights, un logiciel de détection assistée par ordinateur alimenté par l'intelligence artificielle, dans l'UE et au Royaume-Uni. La solution, qui analyse automatiquement les radiographies 2D, sera présentée au 2025 IDS Dental Show à Cologne.
Le logiciel, qui fait partie de la Align Digital Platform, aide les médecins à diagnostiquer des conditions de santé bucco-dentaire grâce à la détection par IA des caries, des radiolucences périapicales et de la perte osseuse parodontal. Les premières enquêtes auprès des utilisateurs ont montré que 95 % des médecins le trouvaient utile pour communiquer sur les conditions de santé buccale, tandis que 91 % ont signalé une amélioration de la confiance des patients et de l'acceptation des traitements.
La version de bureau/tablette sera disponible à partir du 25 mars 2025, avec une intégration du scanner iTero prévue pour le lancement. Le logiciel a reçu l'approbation réglementaire en Europe, au Royaume-Uni, au Canada et en Nouvelle-Zélande, avec des approbations en attente dans d'autres marchés, y compris l'approbation FDA 510K aux États-Unis. Un essai gratuit de 60 jours est proposé dans le cadre du lancement.
Align Technology (NASDAQ: ALGN) hat Align X-ray Insights, eine KI-gestützte Software zur computerunterstützten Detektion, in der EU und im Vereinigten Königreich eingeführt. Die Lösung, die 2D-Röntgenaufnahmen automatisch analysiert, wird auf der 2025 IDS Dental Show in Köln vorgestellt.
Die Software, die Teil der Align Digital Platform ist, hilft Ärzten, zahnmedizinische und orale Gesundheitszustände durch KI-gestützte Erkennung von Karies, periapikalen Radioluzenzen und parodontalem Knochenverlust zu diagnostizieren. Erste Umfragen unter Nutzern zeigten, dass 95 % der Ärzte sie hilfreich fanden, um orale Gesundheitszustände zu kommunizieren, während 91 % von einem verbesserten Vertrauen der Patienten und einer höheren Akzeptanz der Behandlung berichteten.
Die Desktop-/Tablet-Version wird ab dem 25. März 2025 verfügbar sein, mit geplanter Integration des iTero-Scanners. Die Software hat in Europa, im Vereinigten Königreich, in Kanada und Neuseeland die regulatorische Genehmigung erhalten, während in anderen Märkten, einschließlich der FDA 510K-Zulassung in den USA, Genehmigungen ausstehen. Im Rahmen des Starts wird eine 60-tägige kostenlose Testversion angeboten.
- Strong early user adoption with 95% positive feedback on patient communication
- 91% of users report improved patient trust and treatment acceptance
- Expansion of digital platform capabilities through AI integration
- Regulatory clearances already secured in multiple major markets
- US FDA 510K clearance still pending
- initial availability of iTero integration feature
Insights
Align Technology's launch of X-ray Insights, an AI-powered diagnostic software for dental radiographs in the EU and UK, represents a strategic product expansion that strengthens their digital platform ecosystem. This builds upon their 2022 acquisition of dentalXrai GmbH, demonstrating effective integration of acquired technology to create new revenue streams.
The product addresses a critical workflow component for dental professionals by using AI to analyze radiographs for conditions like caries, periapical radiolucencies, and periodontal bone loss. Early user data showing
From a business perspective, this expands Align's addressable market beyond their core orthodontic focus into broader dental diagnostics. The product strategically complements their existing Invisalign system, iTero scanners, and exocad CAD/CAM software, creating a more comprehensive digital workflow that could increase customer retention and lifetime value.
The regulatory progress is notable, with clearance already secured in Europe, UK, Canada, and New Zealand, though pending in the important US market. The 60-day free trial offer suggests confidence in the product's ability to demonstrate value quickly, potentially accelerating adoption rates.
This launch reinforces Align's shift from being primarily an orthodontic company to becoming a comprehensive digital dentistry platform provider, potentially opening new growth avenues beyond their traditional clear aligner business.
Align's X-ray Insights represents a significant advancement in dental AI diagnostic technology, applying computer vision and deep learning to analyze 2D radiographs for multiple conditions simultaneously. The system appears to function as both a diagnostic aid and a communication tool, with the AI generating visual overlays of detected abnormalities.
What's technically impressive is the breadth of detection capabilities spanning caries (decay), periapical radiolucencies (potential infections), and periodontal bone loss – conditions that significantly impact treatment planning. By automating the detection process, the technology potentially reduces diagnostic variability between practitioners while standardizing analysis.
The integration architecture is particularly noteworthy, with both standalone cloud access via desktop/tablet and planned iTero scanner integration. This dual-deployment approach maximizes accessibility while creating technical synergy with Align's existing hardware investments. The cloud-based implementation enables rapid updates and improvements to the AI models without requiring users to manage software updates.
The technology complements Align's existing NIRI (Near Infra-Red Imaging) capabilities in iTero scanners, potentially creating a multi-modal diagnostic approach combining surface scanning and radiographic analysis. This represents a technical evolution from Align's traditional focus on treatment delivery (aligners) to comprehensive diagnostic capabilities.
From a medical adoption perspective, the
The Solution to be Showcased at 2025 IDS Dental Show in
ROTKREUZ,
Align X-ray Insights, an AI Computer-Aided Detection Software (Photo: Business Wire)
As part of the Align™ Digital Platform, Align X-ray Insights software is designed to support doctors to diagnose dental and oral health conditions, standardize analysis, streamline workflows, and improve patient engagement. A recent survey among early doctor users of the technology showed it helped
After confirming diagnosis, doctors can use the Align X-ray Insights detailed report, automatic tooth charting, and color overlays of radiographic abnormalities for patient education and treatment planning. The AI detection functionalities include caries, periapical radiolucencies and periodontal bone loss and other conditions.
Align X-ray Insights – alongside Align™ Oral Health Suite, a comprehensive digital suite providing a clinical framework to empower engaging oral health conversations – further reinforces Align’s commitment to dental diagnostics by launching an X-ray diagnostic digital solution that can enhance the already available NIRI (Near Infra-Red Imaging) technology with iTero intraoral scanners and Oral Health Suite’s capabilities, with the objective to support and advance doctor treatment planning decisions and priorities, based on the patient records available.
“Align X-ray Insights represents a significant advancement in our digital restorative dentistry solutions with broader patient applicability,” said Simon Beard, Align Technology executive vice president and managing director,
“It is fantastic to see Align X-ray Insights being integrated into Align’s digital platform – bringing diagnostic AI capabilities to dentists all over the world. When we started our journey towards AI in dental diagnostics, we had hoped to improve patient outcomes via better diagnostics and treatment decisions,” said Professor Falk Schwendicke, director of the Dental Clinic at University of
Align Technology acquired dentalXrai GmbH in 2022 and has since worked on integrating its flagship product into the Align Digital Platform. Align X-ray Insights, a cloud-based software, can be accessed either from any desktop or tablet or through an integration with iTero. The desktop / tablet version becomes generally available in the European Union and
For more information, interested customers can visit www.alignxrayinsights.com. As part of the launch offer, doctors can benefit from a 60-day free-trial.
*CADe = computer-aided detection
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Based on a survey of n=24 doctors (19 GP / 5 orthodontists) using Align™ X-ray Insights in
Europe (FR,UK , IT, DE, ES, NL, DK and LV) who were part of a limited market release. Doctors indicated their agreement with different statements using a 4-point scale from strongly agree to strongly disagree. Statements included “Align X-ray Insights, when shown to patients, increased treatment acceptance of restorative procedures.” (91% agreement), “Align X-ray Insights streamlines the dental diagnostic workflow, helping me save valuable time.” (70% agreement), “Align X-ray Insights contributes to higher trust when shown to patients during treatment option discussions.” (91% agreement) and “Align X-ray Insights helps me communicate patient oral health conditions and treatment options.” (95% agreement). Align X-ray Insights is intended to be used in conjunction with an evaluation by the doctor and should not be solely relied upon to make or confirm a diagnosis. Data on file at Align Technology as of January 2025.
About Align Technology, Inc.
Align Technology designs and manufactures the Invisalign® System, iTero™ intraoral scanners and services, and exocad™ CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for over 271.6 thousand doctor customers and is key to accessing Align’s 600 million consumer market opportunity worldwide. Over the past 28 years, Align has helped doctors treat approximately 19.5 million patients with the Invisalign System and is driving the evolution in digital dentistry through the Align™ Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners. Visit www.aligntech.com for more information.
For additional information about the Invisalign System or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about the iTero digital scanning system, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.
Invisalign, iTero, exocad, Align, and Align Digital Platform are trademarks of Align Technology, Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250310448632/en/
Align Technology
Madelyn Valente
(909) 833-5839
mvalente@aligntech.com
Zeno Group
Sarah Karlson
(828) 551-4201
sarah.karlson@zenogroup.com
Source: Align Technology, Inc.
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