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
Smoke Free Sweden: Brussels Warned Against Depriving Women of Best Tool to Quit Smoking6.3.2026 10:28:00 CET | Press release
On International Women’s Day (March 8), health experts are warning EU policymakers not to jeopardise women’s health by restricting or banning nicotine pouches that have helped drive one of the world’s most dramatic declines in female smoking. The warning accompanies the release of Empowerment in a Pouch, a report showing how access to oral, tobacco-free nicotine pouches has accelerated Sweden’s progress towards smoke-free status, particularly among women. European Commission proposals under consideration in the Tobacco Products Directive could reverse this progress if applied across the EU, where more than one in five women still smokes. “Sweden’s experience shows what happens when women are given realistic alternatives to smoking,” said Professor Marewa Glover, behavioural scientist and co-author. “Remove those options and you remove momentum. The danger now is that European policy ignores success and repeats past mistakes.” The report shows that since nicotine pouches became availabl
Andersen Consulting udvider platformen med Reach Consulting5.3.2026 22:05:00 CET | Pressemeddelelse
Andersen Consulting udvider sin platform i Mellemøsten gennem en samarbejdsaftale med Reach Consulting, et digitalt transformations- og rådgivningsfirma med hovedsæde i De Forenede Arabiske Emirater. Reach Consulting hjælper organisationer med at skabe vækst, håndtere risici og navigere i komplekse forandringer gennem en omfattende portefølje af ydelser, herunder digital transformation, strategi, intern revision og M&A-rådgivning. Med en tilstedeværelse i De Forenede Arabiske Emirater, Saudi-Arabien, Oman, Qatar og Jordan betjener firmaet kunder i både den offentlige og private sektor med skræddersyede løsninger, tværfaglig ekspertise og indgående lokalkendskab. Reach Consulting kombinerer skala med agilitet for at fremme driftsresultater og innovation i arbejdsstyrken. "Transformation fungerer bedst, når lokal indsigt, tværfaglig ekspertise og praktisk udførelse spiller sammen," udtalte Suhail Shaker, administrerende direktør for Reach Consulting. "Ved at samarbejde med Andersen Consu
2PointZero Group Completes Majority Acquisition in Italy-Based ISEM Packaging Group for AED 704 Million5.3.2026 22:02:00 CET | Press release
Transaction results in 60.8% ownership by 2PointZero Packaging becomes the sixth consumer-focused vertical with ISEM as an anchor 2PointZero Group PJSC (ADX: 2PointZero), a next-generation investment powerhouse focused on energy and consumer sectors, announced today that it has formally completed the transaction to acquire a majority position in ISEM, a leading European packaging group serving beauty, fashion, luxury, nutraceuticals and more, for AED 704 million through a combination of secondary and primary capital earmarked to accelerate organic and inorganic growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305800523/en/ 2PointZero Group completes majority acquisition in Italy-based ISEM Packaging Group for AED 704 million (Photo: AETOSWire) 2PointZero Group now holds 60.8% of ISEM, while Peninsula Capital and minority investors own the remaining 39.2%. This marks the start of a strategic partnership between 2Poin
Xsolla Announces Reseller Program to Help Game Developers Unlock New Revenue Streams in Local Markets5.3.2026 18:00:00 CET | Press release
Game Developers And Publishers Can Now Reach More Players By Partnering with Official Distributors And Resellers Globally Without Building Local Infrastructure Xsolla, a leading global video game commerce company, today announced the Xsolla Reseller Program, a new product designed to help game developers scale and capture untapped revenue in local markets with no development needed. The program launches with a curated cohort of resellers and distributors in Southeast Asia and Latin America, with expansion into additional regions throughout 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305047070/en/ Graphic: Xsolla As game developers pursue global growth, they face a fundamental infrastructure challenge: billions of dollars in revenue remain untapped in emerging, cash-dependent economies, such as Southeast Asia, Latin America, the Middle East, and North Africa, where players purchase digital content through local di
Andersen Consulting styrker sine kompetencer inden for cybersikkerhed gennem samarbejde med A3Sec5.3.2026 17:16:00 CET | Pressemeddelelse
Andersen Consulting styrker sine tilbud inden for cybersikkerhed og teknologisk transformation gennem en samarbejdsaftale med A3Sec, et firma, der specialiserer sig i datadrevet trusselsdetektion, hændelsesrespons og exposure management. Med hovedsæde i Spanien og kontorer i Mexico og Colombia har A3Sec mere end 14 års erfaring med at hjælpe offentlige og private organisationer inden for finans, telekommunikation, energi, den offentlige sektor og erhvervslivet med at sikre deres digitale aktiver. Virksomheden driver sit Security and Digital Surveillance Center® (CSVD®) døgnet rundt med et team på over 180 cybersikkerhedseksperter og betjener mere end 280 kunder verden over. Firmaet leverer integrerede cybersikkerhedstjenester, herunder managed detection and response, cybertelemetri, trusselsanalyse og krisestyring, og hjælper kunder med at styrke deres robusthed og omdanne risiko til en strategisk fordel, samtidig med at de effektivt håndterer eksponering og minimerer risiko. "Vores fo
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