DENTALMONITORING
20.5.2024 21:17:35 CEST | Business Wire | Press release
DentalMonitoring®, the leader in AI-powered remote monitoring for orthodontic treatment, has received De Novo approval from the U.S. Food and Drug Administration (FDA) for the DentalMonitoring solution to be used by orthodontists in optimizing clinical care.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240520240852/en/
DentalMonitoring Sets New Standard in Orthodontic Remote Monitoring with De Novo Approval by the U.S. Food and Drug Administration (FDA) (Graphic: Business Wire)
DentalMonitoring is a medical device software using image processing algorithms to analyze pictures of the oral cavity (hereinafter Scans). Scans are taken using the DM App, a smartphone, and the manufacturer’s proprietary hardware products. DentalMonitoring is indicated for use for patients over the age of 6 and reports results solely on permanent teeth.
The product is designed to assist healthcare professionals in remotely monitoring dental treatments, orthodontic treatments, oral health, and treatment progress. The results of DentalMonitoring are intended to be used as an aid in diagnosis and not on a stand-alone basis for clinical decision-making.
DentalMonitoring provides additional information compared to traditional orthodontic treatment follow-up. DentalMonitoring is an additional asset to ensure patient compliance to orthodontic treatment requirements. With DentalMonitoring, clinicians enjoy an elevated level of insight into treatment progress while patients enjoy increased convenience. Automated notifications and in-app communication with practice staff increase patient accountability and enhance communication between patients, healthcare providers, and caregivers.
With this approval, DentalMonitoring will also introduce the innovative SmartSTL™ feature to North American orthodontist customers. SmartSTL allows doctors to request updated STL files via the DentalMonitoring dashboard without bringing the patient back into the office.
“We are proud to be the new standard of care in orthodontics. This is a recognition of our 10 years of research and development in Deep Learning Artificial Intelligence. FDA approval of this improved version of DentalMonitoring software is a key milestone for DentalMonitoring and marks the beginning of a new era in orthodontics,” says Philippe Salah, CEO and co-founder of DentalMonitoring.
Since 2012, only four De Novos have been granted by the FDA Dental panel, and none were software-based devices. DentalMonitoring is the first Artificial Intelligence/Machine Learning-enabled Software as a Medical Device in dentistry, establishing a classification within FDA dental regulation numbers and product codes. With the grant of this De Novo and the creation of a new regulatory category, DentalMonitoring has paved the way for future innovations in the Software as a Medical Device in the dental field category.
This clearance is a result of Dental Monitoring’s investment in pushing digital health technologies to the forefront of dental care. DentalMonitoring’s innovation has benefited users with elevated clinical outcomes and increased their peace of mind.
About DentalMonitoring:
DentalMonitoring is transforming orthodontic care globally through our advanced AI-driven platform. Our mission is to empower orthodontic practitioners with precise, real-time treatment monitoring and decision-making tools. By enhancing the connection between clinicians and patients, we make it possible to optimize treatment outcomes and ensure high-quality, efficient, and personalized orthodontic experiences.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240520240852/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Alsym Energy Announces Na-Series Battery Success Developed With Physics-Informed AI Platform27.4.2026 21:25:00 CEST | Press release
Alsym’s proprietary physics-informed AI platform powered the development of its Na-Series batteries—a non-flammable, high performance and low cost energy solution positioned to serve critical energy storage markets including data centers, utilities, telecommunications, commercial real estate, industrial and defense, among others. Alsym Energy, a pioneer in non-flammable, high-performance sodium-ion batteries, today announced details of the proprietary physics-informed AI platform used to develop the company’s recently launched Na-Series sodium-ion batteries. By integrating fundamental physics models with AI, autonomous testing and proprietary molecular diagnostics in a closed-loop system, Alsym is accelerating the design of safer, inexpensive, commercialized batteries through all phases of the development cycle. As global demand for electricity surges, the limitations of lithium-ion batteries have become increasingly apparent, particularly around safety and supply chain constraints. Li
Backed by Investments Exceeding $1 Billion, PCI Pharma Services Announces Major Expansion of US Sterile Fill-Finish and Drug-Device Delivery Combination Capabilities27.4.2026 16:00:00 CEST | Press release
As pharma manufacturers prioritize US supply chain resilience, highlights include high-speed isolator filling lines for prefilled syringes, cartridges and vials, and drug-device combination assembly and packaging. PCI Pharma Services (“PCI”) – a world-leading integrated global contract development and manufacturing organization (CDMO) focused on innovative biologic and small molecule therapies – announced a series of major infrastructure investments that substantially deepen its sterile fill-finish and advanced drug delivery capabilities. As pharma manufacturers and their development partners increasingly prioritize US supply chain resilience, PCI’s latest investments come as part of a broader commitment exceeding $1 billion across the CDMO’s US and European operations, reinforcing its ability to provide seamless support for drug product development and manufacturing, clinical trial supply and drug-device combination assembly from clinical stages through commercial launch – all underpi
Pure Lithium Appoints Renowned Battery Expert Dr. Yuan Gao to Board of Directors27.4.2026 15:53:00 CEST | Press release
Pure Lithium Corporation, a vertically integrated lithium metal battery technology company, is pleased to announce that world-renowned inventor and battery expert Dr. Yuan Gao has joined the company’s Board of Directors. Dr. Gao has been an invaluable member of Pure Lithium’s Scientific Advisory Board since October of 2023. "We are thrilled to have Dr. Gao join our board as we focus on rapidly scaling our technology in the most capital efficient manner possible,” said Pure Lithium Founder, Chairman and CEO Emilie Bodoin. “Dr. Gao is a brilliant scientist who also has deep commercial expertise, a rare combination. He is also unique in the industry because his experience spans the entire battery materials value chain, including all of Pure Lithium’s verticals. His insights over the years have been critical in advancing our technology, and his experience as a director of public companies will strengthen our board.” Dr. Gao commented: “I am thrilled to join the board of Pure Lithium Corpor
Taiho Oncology, Taiho Pharmaceutical and Araris Biotech AG Advance ADC ARC-02 into Phase 1 Clinical Development27.4.2026 15:00:00 CEST | Press release
Phase 1 dose-escalation trial represents the first clinical trial of a product developed using the AraLinQ™ ADC technology and marks Taiho’s expansion into the clinical development of ADCs for oncology Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Araris Biotech AG (“Araris”) today announced that the U.S. Food and Drug Administration (FDA) has completed its Investigational New Drug (IND) review period for ARC-02, an antibody-drug conjugate (ADC) being developed for the treatment of non-Hodgkin lymphoma, enabling Taiho Oncology to initiate a Phase 1 dose-escalation clinical trial of ARC-02. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260427127507/en/ Taiho Pharmaceutical acquired Araris Biotech in March 2025, expanding Taiho group’s capabilities in biologics and ADC research and development. Araris is a spin-off of the Paul Scherrer Institute and ETH in Switzerland focused on the development of antibody-drug co
Boomi To Unveil the Future Of Data Activation and AI-Driven Innovation at Boomi World 202627.4.2026 15:00:00 CEST | Press release
Premier global event to highlight how organizations are bringing data to life to power everything from AI to BI Boomi, the data activation company, today announced Boomi World 2026, its premier annual user conference, taking place May 11 - 14, 2026 in Chicago, IL. The event will bring together customers, partners, and industry leaders from around the world to explore how data activation is transforming the enterprise and accelerating the path to AI-driven outcomes. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260427600340/en/ Boomi To Unveil the Future Of Data Activation and AI-Driven Innovation at Boomi World 2026 Boomi World 2026 will spotlight data activation — bringing data to life to power AI, analytics, and intelligent automation. Attendees will gain firsthand insights into how the Boomi Enterprise Platform enables businesses to unify data, streamline operations, and innovate faster in an increasingly agentic world.
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom