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
Ant International and Bank Partners Achieve Real-Time Cross-Bank Liquidity Management through Tokenised Deposits via CeBM under HKMA’s EnsembleTX3.11.2026 05:10:00 CET | Press release
Transfers were among the first batch of live transactions completed under EnsembleTX, unlocking 24/7 liquidity access and near-instant settlement Following the Hong Kong Monetary Authority’s (HKMA) announcement on interbank settlement of tokenised deposit transactions under EnsembleTX, Ant International announced that it has achieved real-time cross-bank liquidity management with its key banking partners as part of its active participation in EnsembleTX. In close collaboration with Bank of China (Hong Kong) (“BOCHK”, SEHK: 2388), China Construction Bank (Asia) (“CCB (Asia)”) and HSBC (SEHK: 5), Ant International successfully completed a series of live HKD interbank transactions between September and October 2026: BOCHK interbank transactions with CCB (Asia) CCB (Asia) interbank transactions HSBC interbank transactions Executed using tokenised deposit settled through the HKMA’s Central Bank Money (CeBM), the transfers were initiated via Ant International’s proprietary blockchain-based w
SuperElastic* Material Unveiled by Angelalign2.11.2026 18:46:00 CET | Press release
New, Improved Clear Aligner Material Gives Orthodontists More Control Angelalign Technology Inc. (6699.HK) (“Angel”)http://www.angelaligner.com, a global clear aligner leader, today unveiled SuperElastic (MC-SE*), a new propietary aligner material that is a significant breakthrough in performance over its current material. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261102654659/en/ Specialists in orthodontics have long asked for new aligner materials that enable better treatment for complex cases: biologically safe force levels, a large elastic working range, and strength and toughness. MC-SE* provides all of them. “Angel is commited to innovation and never settling for 'good enough'. MC-SE* is the result of seven years of materials research, testing and manufacturing optimization. The new material aims to create a new generation of aligner material that allows orthodonists to differentiate their treatment from other tre
Galderma Announces Proposed Board Appointments and Chief Financial Officer Transition2.11.2026 18:00:00 CET | Press release
The Company will hold an Extraordinary General Meeting on December 3, 2026 to further reinforce its Board of DirectorsAd hoc announcement pursuant to Art. 53 LR Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced proposed changes to its Board of Directors, aimed at further strengthening its governance and supporting its long-term growth. The company also announced that Luigi La Corte, Chief Financial Officer (CFO), has decided to leave Galderma to pursue a significant new opportunity. Luigi La Corte will continue to fulfil his responsibilities as CFO during the transition period, supporting business continuity and a smooth handover. The company will communicate further details regarding succession arrangements and the transition timeline in due course. The Board of Directors is proposing the election of Rosalind Brewer and Petra Rumpf as new Board members. Both candidates bring extensive leadership and governance experience, alongside expertise span
Donaldson Introduces Alpha-Pore™ Technology Platform for Extended Sterile Filtration Performance2.11.2026 15:35:00 CET | Press release
Donaldson Company, Inc. (NYSE: DCI), a leading worldwide manufacturer of innovative filtration products and solutions, today announced Alpha‑Pore™ technology, a next generation sterile filtration platform engineered to extend filter service life while maintaining critical process performance. Built for critical applications, Alpha‑Pore technology enables longer filter run time compared with competitive single- and dual-layer polyethersulfone (PES) membrane filters, while maintaining flow characteristics, sterility assurance, and process integrity.* The platform is designed to help manufacturers improve operational efficiency through fewer changeouts and more consistent performance over time. Engineered for Extended Performance Sterile filtration processes often require balancing run time with key performance parameters such as flow, differential pressure, and contaminant retention. Alpha‑Pore technology is designed to achieve all three. By optimizing pore structure and filter architect
SBC Medical Forms Capital and Business Alliance with AtomicSoftware, Provider of the medicalforce Clinic Management Platform Used by 800+ Clinics in Japan2.11.2026 15:00:00 CET | Press release
Companies to co-develop AI features, starting with physician documentation support, to enhance medicalforce and SBC Medical’s in-house systems and drive per-clinic productivity and profitability SBC Medical Group Holdings Incorporated (Nasdaq: SBC) (“The Company” or “SBC Medical”), a Medical Services Organization (MSO) providing management support across a wide range of healthcare fields, today announced that it entered into a capital and business alliance agreement on October 26, 2026, with AtomicSoftware Inc. (“AtomicSoftware”), the Tokyo-based provider of medicalforce, an all-in-one software-as-a-service (SaaS) platform for clinics. In connection with the alliance, SBC Medical has invested ¥600 million (approximately US$3.8 million) in AtomicSoftware’s Series C funding round. The two companies will co-develop AI features, beginning with a feature that supports physicians in preparing medical records. Key HighlightsProven platform: medicalforce is used by more than 800 clinics*1 in J
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