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
Pure Lithium Receives Australian Patent for "Lithium Metal Anode and Battery"6.8.2026 22:49:00 CEST | Press release
Pure Lithium Corporation, a vertically integrated next-generation lithium metal battery technology company, today announced that the Australian patent office has granted the company a patent (AU2025271196) titled “Lithium metal anode and battery.” Australia mines roughly half of the world’s lithium, yet has no domestic battery production at all; every battery the country uses is imported. The granted patent is directed to ways in which Pure Lithium’s technology can change that. Rather than trying to catch up in lithium-ion, Australia can leapfrog the incumbent technology and establish a next-generation industry. As worldwide demand for batteries grows, every country capable of making batteries needs to be making them. That is Pure Lithium’s central goal: opening up markets around the world through battery technology that enables local, independent supply chains, keeping pace with demand and strengthening economies. China controls the lithium-ion battery supply chain and manufactures th
Vercel Appoints Amit Agarwal, Standard Template Labs CEO and former Datadog President, to Board of Directors6.8.2026 17:00:00 CEST | Press release
The product leader who helped scale Datadog from early-stage startup through IPO brings deep product expertise to Vercel's board Vercel, the agentic infrastructure company, today announced the appointment of Amit Agarwal, former president of Datadog and founder and CEO of Standard Template Labs, an AI-first service management platform, to its board of directors. Agarwal brings 25 years of enterprise software experience and a track record of scaling a product-led company from its earliest days into one of the defining public software companies of the cloud era. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806738617/en/ Amit Agarwal Agarwal joined Datadog in 2012 as its Chief Product Officer and was named President in 2022, overseeing product, corporate development, and go-to-market functions as the company grew past $2.5 billion in annual revenue. Across 13 years, including Datadog's 2019 IPO and its first years as a pub
Laserfiche Launches Advanced Enterprise Security to Deliver Multi-Region Disaster Recovery and GovRAMP-Ready Compliance for Highly Regulated Industries6.8.2026 16:00:00 CEST | Press release
New security suite extends Laserfiche’s proven security controls and adds near real-time data replication for governments, law enforcement and security-conscious enterprises. Laserfiche — the leading SaaS provider of intelligent content management — today announced the launch of Enterprise Security, an advanced suite of security enhancements designed for organizations navigating complex regulatory environments. Enterprise Security addresses GovRAMP and CJIS (Criminal Justice Information Services) security requirements based on the NIST SP 800-53 framework. For organizations handling privileged citizen, legal or corporate data, these built-in controls streamline audit preparation and fortify defenses. With organizations placing a higher priority on data stewardship and corporate governance, enterprise IT leaders require a security architecture that protects data without slowing down operations. Laserfiche Enterprise Security extends Laserfiche Cloud’s highly resilient infrastructure wit
AM Best Upgrades Fortegra Insurance Subsidiaries to A (Excellent)6.8.2026 15:00:00 CEST | Press release
Rating actions follow completion of the DB Insurance acquisition The Fortegra Group, Inc. (“Fortegra” or the “Company”), a global specialty insurer and part of DB Insurance Co., Ltd., today announced that AM Best has upgraded the Financial Strength Rating (FSR) of its insurance subsidiaries to A (Excellent) from A- (Excellent) and the Long-Term Issuer Credit Ratings (Long-Term ICRs) to “a” (Excellent) from “a-” (Excellent). The outlook assigned to the ratings is stable, and AM Best removed the ratings from under review with positive implications. KBRA has also upgraded all of its ratings for the Company. The upgrade applies across Fortegra’s insurance platform. The property and casualty companies include Lyndon Southern Insurance Company, Insurance Company of the South, Response Indemnity Company of California, Blue Ridge Indemnity Company, Fortegra Specialty Insurance Company and Fortegra Europe Insurance Company SE. The life and health companies include Life of the South Insurance Co
Khimji Ramdas Group Chooses Rimini Street to Reduce SAP Support Costs, Protect 700+ Customizations and Reinvest Savings in Innovation6.8.2026 15:00:00 CEST | Press release
Omani conglomerate gains greater control over its IT roadmap, avoids migration pressure and funds AI and growth initiatives Rimini Street, Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™ and the leading third-party support provider for Oracle, SAP and VMware software, today announced that Khimji Ramdas Group, one of Oman’s largest privately held conglomerates, has selected Rimini Support™ for SAP, a move that has helped the organization reduce costs, reinvest savings in AI innovation and maintain its highly customized SAP ECC 6 environment with zero downtime. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806244148/en/ Khimji Ramdas Group Chooses Rimini Street to Reduce SAP Support Costs, Protect 700+ Customizations and Reinvest Savings in Innovation “Staying on SAP ECC is a strategic decision for us,” said Prashant Kumar, CTO, Khimji Ramdas Group. “We went to an industry analyst to ask what options
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