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
i2c Named Finalist for Best Security or Anti-Fraud Development at Card & Payments Awards Middle East 202612.2.2026 15:00:00 CET | Press release
i2c’s AI-driven Fraud Risk Management solution recognized for delivering impactful results for Middle East clients i2c Inc., a global financial technology innovator, has been named a finalist in the Best Security or Anti-Fraud Development category at The Card & Payments Awards Middle East 2026. The region’s premier awards program recognizes organizations that deliver practical, high-impact innovations to strengthen payment security and protect customers in one of the world’s fastest-growing digital payments markets. i2c was recognized for its AI-driven Fraud Risk Management solution, embedded directly within its unified banking and payments platform and operating in real time at the point of transaction authorization—an increasingly critical capability as digital payments scale across Middle East markets. By evaluating risk at the moment a payment is initiated, rather than after funds are approved, the solution enables earlier detection of fraudulent activity while preserving approval
SLB Awarded Multiple Offshore Drilling Contracts by Mubadala Energy for Tangkulo Deepwater Development in Indonesia12.2.2026 14:00:00 CET | Press release
Contracts support offshore gas development with first gas targeted before end of 2028 Global energy technology company SLB (NYSE: SLB) has been awarded multiple offshore drilling services contracts by Mubadala Energy, the Abu Dhabi headquartered international energy company, for the Tangkulo natural gas deepwater development and associated exploration and appraisal drilling activities in the Andaman Sea, offshore Indonesia. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260212809124/en/ The project will leverage SLB’s offshore and deepwater technologies, including real-time downhole monitoring, to reduce operational risk, improve well placement and strengthen project economics. Under the awards, SLB will work with Mubadala Energy to deliver integrated drilling and well services across the full well life cycle. The scope includes directional drilling, drilling fluids, cementing, wireline, slickline, coiled tubing, well testin
Align Partners Issues Formal Shareholder Proposals to Dentium12.2.2026 13:43:00 CET | Press release
Align Partners Capital Management Inc. (“Align Partners”), a shareholder of Dentium Co., Ltd. (“Dentium” or the “Company”), has submitted formal shareholder proposals for inclusion in the agenda of Dentium’s upcoming 26th Annual General Meeting (“AGM”), urging the Company to strengthen governance practices and improve capital allocation discipline. Align Partners noted that, given shareholder proposals will be presented at this year’s AGM, Dentium should follow the Korea Exchange (KRX) Corporate Governance Key Indicators by publishing the AGM convocation notice at least four weeks prior to the meeting date and adopting an electronic voting system to enhance shareholder participation. Dentium is widely recognized as a global leader in the dental implant industry, supported by superior technology and more than 23 years of long-term clinical data. Despite this strong positioning, Align Partners believes the Company continues to trade at a meaningful discount. As of February 11, 2026, Dent
Align Partners Issues Public Shareholder Letter and Submits Formal Shareholder Proposals to SoluM12.2.2026 13:42:00 CET | Press release
Align Partners Capital Management Inc. (“Align Partners”), a shareholder of SoluM Co., Ltd. (“SoluM” or the “Company”), has submitted formal shareholder proposals for inclusion in the agenda of SoluM’s 2026 Annual General Meeting (“AGM”) and issued its first public shareholder letter to the Company’s Board of Directors. Align Partners requested that SoluM’s Board and management provide a public written response to the shareholder letter by the AGM convocation notice deadline ahead of the March 2026 meeting. The campaign reflects Align Partners’ view that meaningful governance reforms and strategic focus are urgently needed to unlock shareholder value. SoluM operates a high-growth Electronic Shelf Label (“ESL”) business with strong global positioning and attractive long-term market potential. Despite this, the Company’s share price has remained near historical lows since its listing. As of February 11, 2026, SoluM trades at a last-twelve-month EV/EBIT multiple of 28.9x, representing a s
GigaDevice Extends European Reach with SEMITRON Partnership for DACH region12.2.2026 10:52:00 CET | Press release
GigaDevice, a leading semiconductor company specializing in Flash memory, 32-bit microcontrollers (MCUs), sensors, and analog products, has entered into a distribution agreement with SEMITRON, a leading electronic component distributor that specializes with a focus on the DACH region. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260203746978/en/ Under the terms of the deal, SEMITRON is set to supply both GigaDevice's leading Flash, MCU, power and sensor lines in conjunction with field application engineering support to customers in the industrial, automotive and communication technology sectors. In particular, SEMITRON offers professional test house services, technical know-how and local on-the-ground expertise and support. The partnership further extends GigaDevice's reach into this major European market, with on the ground support in Germany, Austria, Switzerland. Jürgen Rohland, Managing Director of SEMITRON W. Röck Gmb
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