Skip to Content Facebook Feature Image

DentalMonitoring Sets New Standard In Orthodontic Remote Monitoring With De Novo Approval By the U.S. Food and Drug Administration (FDA).

News

DentalMonitoring Sets New Standard In Orthodontic Remote Monitoring With De Novo Approval By the U.S. Food and Drug Administration (FDA).
News

News

DentalMonitoring Sets New Standard In Orthodontic Remote Monitoring With De Novo Approval By the U.S. Food and Drug Administration (FDA).

2024-05-21 03:17 Last Updated At:03:20

PARIS--(BUSINESS WIRE)--May 20, 2024--

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 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.

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 Sets New Standard in Orthodontic Remote Monitoring with De Novo Approval by the U.S. Food and Drug Administration (FDA) (Graphic: Business Wire)

WOODSTOCK, England (AP) — Leaders from across Europe gathered at a grandiose English country mansion on Thursday for a summit clouded by worries about whether the United States would remain a reliable ally if Donald Trump wins a second presidency.

Newly elected U.K. Prime Minister Keir Starmer welcomed some 45 heads of government to discuss migration, energy security and the threat from Russia as he seeks to restore relations between the U.K. and its European Union neighbors four years after their acrimonious divorce.

Starmer told the European Political Community gathering that the U.K. plans to take a more active role on the world stage, especially when it comes to Ukraine's fight against Russia’s invasion and to people-smuggling gangs organizing irregular migration.

He told fellow leaders that under his government the U.K. would be “a friend and a partner, ready to work with you — not part of the European Union, but very much part of Europe. Not focused on the differences between us, but on the values that we share."

“Our first task here today is to confirm our steadfast support for Ukraine, to unite once again behind those values that we cherish and to say we will face down aggression on this continent together,” he said, adding that the threat from Russia “reaches right across Europe.”

Ukrainian President Volodymyr Zelenskyy was a key guest at the meeting, aimed at shoring up Europe’s support for his country’s defense and discussing ways to defend democracy. The U.K. accuses Moscow of seeking to undermine European democracies with cyberattacks, disinformation and sabotage.

When Britain agreed earlier this year to hold the one-day summit, Conservative leader Rishi Sunak was prime minister. His defeat in a July 4 election means it’s Starmer who welcomed leaders to Blenheim Palace, a Baroque country house that was the birthplace of World War II Prime Minister Winston Churchill.

“It’s an incredibly useful occasion for Keir Starmer, because it gives him the chance to get to know a lot of European leaders,” said Jill Rutter, a senior research fellow at the Institute for Government think tank. “It’s like Rishi Sunak organized a dating party for him.”

The guest list includes German Chancellor Olaf Scholz, French President Emmanuel Macron, Italian Prime Minister Giorgia Meloni, Polish Prime Minister Donald Tusk and NATO Secretary-General Jens Stoltenberg.

The meeting is the fourth for the EPC group, a brainchild of Macron. It was established in 2022 as a forum for countries both inside and outside the 27-nation EU after Russia’s full-scale invasion of Ukraine shattered Europe’s sense of security. Previous meetings of the group have been held in the Czech capital, Prague; Chisinau, Moldova; and Granada, Spain.

The U.K. hopes this will be the best-attended summit to date, though EU chief Ursula von der Leyen stayed away as she fights to secure a second term as European Commission president from lawmakers in the European Parliament. Turkish President Recep Tayyip Erdogan was also a no-show.

Starmer’s center-left government aims to rebuild ties with the EU strained by years of ill-tempered wrangling over Brexit divorce terms. A key priority is a new U.K.-EU security pact that Starmer hopes to strike soon.

“We are confident that a new chapter will be opened with the U.K.,” European Council President Charles Michel said as he arrived.

The U.K. plans to work more closely with the European police agency Europol against people smuggling, part of measures to beef up border security following Starmer’s decision to scrap the Conservatives’ contentious and unrealized plan to send migrants arriving in the U.K. by boat on a one-way trip to Rwanda.

Delegates gathered at Blenheim Palace, about 60 miles (100 kilometers) northwest of London, will be treated to full British hospitality, including strawberries with cream and a reception hosted by King Charles III.

Many thoughts will likely stray to the U.S., where the weekend assassination attempt on Trump, the Republican presidential nominee, underscored how febrile and polarized politics has become ahead of the Nov. 5 election.

Trump’s skepticism about NATO has long worried U.S. allies. Trump’s choice of Sen. JD Vance, an opponent of U.S. military aid to Ukraine, as vice presidential running mate has heightened concerns.

“European countries must stand on their own legs more than ever,” said Netherlands Prime Minister Dick Schoof.

That sentiment was echoed by several other leaders, but not by Hungary's pro-Russian Prime Minister Viktor Orbán, who has riled other EU nations with a series of rogue meetings with foreign leaders about Ukraine, including Russian President Vladimir Putin.

Orban said a Trump victory would be “the best news for everybody, because he's a man of the people.”

Associated Press journalist Sylvain Plazy in Brussels contributed to this story.

British Prime Minister Keir Starmer, right, gestures as he speaks during the first plenary session, with Ukrainian President Volodymyr Zelenskyy, left, at the European Political Community meeting in Blenheim Palace, Woodstock, England, Thursday, July 18, 2024. (AP Photo/Kin Cheung, Pool)

British Prime Minister Keir Starmer, right, gestures as he speaks during the first plenary session, with Ukrainian President Volodymyr Zelenskyy, left, at the European Political Community meeting in Blenheim Palace, Woodstock, England, Thursday, July 18, 2024. (AP Photo/Kin Cheung, Pool)

British Prime Minister Keir Starmer, right, gestures as he speaks with Ukrainian President Volodymyr Zelenskyy, left, before the start of the first plenary session at the European Political Community meeting in Blenheim Palace, Woodstock, England, Thursday, July 18, 2024. (AP Photo/Kin Cheung, Pool)

British Prime Minister Keir Starmer, right, gestures as he speaks with Ukrainian President Volodymyr Zelenskyy, left, before the start of the first plenary session at the European Political Community meeting in Blenheim Palace, Woodstock, England, Thursday, July 18, 2024. (AP Photo/Kin Cheung, Pool)

Britain's Prime minister Keir Starmer, centre, makes remarks at the opening plenary session during the European Political Community meeting at Blenheim Palace in Woodstock, England, Thursday, July 18, 2024. From the left is the Prime Minister of Denmark Mette Frederiksen, Ukrainian President Volodymyr Zelenskyy, Prime Minister of Britain Keir Starmer, Charles Michel President of the Council of Europe and President of Moldova Maia Sandu (AP Photo/Kin Cheung, Pool)

Britain's Prime minister Keir Starmer, centre, makes remarks at the opening plenary session during the European Political Community meeting at Blenheim Palace in Woodstock, England, Thursday, July 18, 2024. From the left is the Prime Minister of Denmark Mette Frederiksen, Ukrainian President Volodymyr Zelenskyy, Prime Minister of Britain Keir Starmer, Charles Michel President of the Council of Europe and President of Moldova Maia Sandu (AP Photo/Kin Cheung, Pool)

British Prime Minister Keir Starmer, right, gestures as he speaks with Ukrainian President Volodymyr Zelenskyy, left, before the start of the first plenary session at the European Political Community meeting in Blenheim Palace, Woodstock, England, Thursday, July 18, 2024. (AP Photo/Kin Cheung, Pool)

British Prime Minister Keir Starmer, right, gestures as he speaks with Ukrainian President Volodymyr Zelenskyy, left, before the start of the first plenary session at the European Political Community meeting in Blenheim Palace, Woodstock, England, Thursday, July 18, 2024. (AP Photo/Kin Cheung, Pool)

President of Kosovo Vjosa Osmani arrives to attend the European Political Community summit at Blenheim Palace in Woodstock, Oxfordshire, England, Thursday July 18, 2024. (Jacob King/Pool Photo via AP)

President of Kosovo Vjosa Osmani arrives to attend the European Political Community summit at Blenheim Palace in Woodstock, Oxfordshire, England, Thursday July 18, 2024. (Jacob King/Pool Photo via AP)

Prime Minister of Estonia Kaja Kallas arrives to attend the European Political Community summit at Blenheim Palace in Woodstock, Oxfordshire, England, Thursday July 18, 2024. (Jacob King/Pool Photo via AP)

Prime Minister of Estonia Kaja Kallas arrives to attend the European Political Community summit at Blenheim Palace in Woodstock, Oxfordshire, England, Thursday July 18, 2024. (Jacob King/Pool Photo via AP)

Prime Minister of the Netherlands Dick Schoof arrives to attend the European Political Community summit at Blenheim Palace in Woodstock, Oxfordshire, England, Thursday, July 18, 2024. (Jacob King/PA via AP, Pool)

Prime Minister of the Netherlands Dick Schoof arrives to attend the European Political Community summit at Blenheim Palace in Woodstock, Oxfordshire, England, Thursday, July 18, 2024. (Jacob King/PA via AP, Pool)

Chancellor of Germany Olaf Scholz arrives to attend the European Political Community summit at Blenheim Palace in Woodstock, Oxfordshire, England, Thursday July 18, 2024. (Jacob King/Pool Photo via AP)

Chancellor of Germany Olaf Scholz arrives to attend the European Political Community summit at Blenheim Palace in Woodstock, Oxfordshire, England, Thursday July 18, 2024. (Jacob King/Pool Photo via AP)

Prime Minister of Hungary Viktor Orban gestures as he arrives to attend the European Political Community summit at Blenheim Palace in Woodstock, Oxfordshire, England, Thursday July 18, 2024. (Jacob King/Pool Photo via AP)

Prime Minister of Hungary Viktor Orban gestures as he arrives to attend the European Political Community summit at Blenheim Palace in Woodstock, Oxfordshire, England, Thursday July 18, 2024. (Jacob King/Pool Photo via AP)

President of Ukraine Volodymyr Zelenskyy arrives at the European Political Community summit at Blenheim Palace in Woodstock, Oxfordshire, England, Thursday, July 18, 2024. (Stefan Rousseau/PA via AP, Pool)

President of Ukraine Volodymyr Zelenskyy arrives at the European Political Community summit at Blenheim Palace in Woodstock, Oxfordshire, England, Thursday, July 18, 2024. (Stefan Rousseau/PA via AP, Pool)

Britain's Prime Minister Sir Keir Starmer, right, greets Ukrainian President Volodymyr Zelenskyy as he arrives to attend the European Political Community summit at Blenheim Palace in Woodstock, Oxfordshire, England, Thursday July 18, 2024. (Jacob King/Pool Photo via AP)

Britain's Prime Minister Sir Keir Starmer, right, greets Ukrainian President Volodymyr Zelenskyy as he arrives to attend the European Political Community summit at Blenheim Palace in Woodstock, Oxfordshire, England, Thursday July 18, 2024. (Jacob King/Pool Photo via AP)

President of Ukraine Volodymyr Zelenskyy, left, is welcomed by Prime Minister Sir Keir Starmer, right, to the European Political Community summit at Blenheim Palace in Woodstock, Oxfordshire, England, Thursday, July 18, 2024. (Stefan Rousseau/PA via AP, Pool)

President of Ukraine Volodymyr Zelenskyy, left, is welcomed by Prime Minister Sir Keir Starmer, right, to the European Political Community summit at Blenheim Palace in Woodstock, Oxfordshire, England, Thursday, July 18, 2024. (Stefan Rousseau/PA via AP, Pool)

Ukrainian President Volodymyr Zelenskyy arrives to attend the European Political Community summit at Blenheim Palace in Woodstock, Oxfordshire, England, Thursday July 18, 2024. (Jacob King/Pool Photo via AP)

Ukrainian President Volodymyr Zelenskyy arrives to attend the European Political Community summit at Blenheim Palace in Woodstock, Oxfordshire, England, Thursday July 18, 2024. (Jacob King/Pool Photo via AP)

The President of France Emmanuel Macron listens to British Prime Minister Keir Starmer during the first plenary session at the European Political Community meeting in Blenheim Palace, Woodstock, England , Thursday, July 18, 2024. (AP Photo/Kin Cheung, Pool)

The President of France Emmanuel Macron listens to British Prime Minister Keir Starmer during the first plenary session at the European Political Community meeting in Blenheim Palace, Woodstock, England , Thursday, July 18, 2024. (AP Photo/Kin Cheung, Pool)

Britain's Prime Minister Sir Keir Starmer, right, greets France's President Emmanuel Macron as he arrives to attend the European Political Community summit at Blenheim Palace in Woodstock, Oxfordshire, England, Thursday July 18, 2024. (Jacob King/Pool Photo via AP)

Britain's Prime Minister Sir Keir Starmer, right, greets France's President Emmanuel Macron as he arrives to attend the European Political Community summit at Blenheim Palace in Woodstock, Oxfordshire, England, Thursday July 18, 2024. (Jacob King/Pool Photo via AP)

British Prime Minister Keir Starmer, right, speaks during the first plenary session, with Ukrainian President Volodymyr Zelenskyy, left, at the European Political Community meeting in Blenheim Palace, Woodstock, England , Thursday, July 18, 2024. (AP Photo/Kin Cheung, Pool)

British Prime Minister Keir Starmer, right, speaks during the first plenary session, with Ukrainian President Volodymyr Zelenskyy, left, at the European Political Community meeting in Blenheim Palace, Woodstock, England , Thursday, July 18, 2024. (AP Photo/Kin Cheung, Pool)

FILE - A view of Blenheim Palace in Woodstock, Oxfordshire, England, March 24, 2009. Leaders from across Europe gather at an English country mansion on Thursday, July 18, 2024, for a summit overshadowed by worries about whether the United States will remain a reliable ally if Donald Trump secures a second presidency. (Steve Parsons/PA via AP, File)

FILE - A view of Blenheim Palace in Woodstock, Oxfordshire, England, March 24, 2009. Leaders from across Europe gather at an English country mansion on Thursday, July 18, 2024, for a summit overshadowed by worries about whether the United States will remain a reliable ally if Donald Trump secures a second presidency. (Steve Parsons/PA via AP, File)

Recommended Articles