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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)

WELLINGTON, New Zealand (AP) — New Zealand’s government will overhaul the tighter gun laws introduced after a deadly mass shooting by a white supremacist five years ago, because they put excessive burdens on gun owners who feel vilified by law enforcement and the public, the lawmaker leading the changes said.

“What’s happened is a massive change with massive penalties and targets on people who didn’t do anything wrong,” Associate Justice Minister Nicole McKee — a lobbyist for gun owners before she entered Parliament in 2020 — told The Associated Press in an interview this week. Every part of the law will be scrutinized, including the restrictions that bar all but a few hundred New Zealanders from firing banned semiautomatic weapons, she said.

McKee’s pledge of a wide-ranging review — following an earlier announcement that she would ease rules for gun clubs — was applauded by groups representing the country’s 250,000 license holders and decried by survivors of the 2019 terrorist attack at two Christchurch mosques where an Australian man opened fire on Muslim worshippers, killing 51 people.

“It makes me scared for our futures,” Temel Ataçocuğu — who was shot nine times in the attack and fears an erosion of the assault weapon ban — told the AP. “What have the past five years been for? How are they going to prevent this from happening again?”

New Zealand drew global admiration when its then-Prime Minister Jacinda Ardern said six days after the massacre that her government would outlaw all semiautomatic weapons. The change was approved by 119 lawmakers with only one opposed, and sweeping reforms followed: bolstered licensing requirements, more rules for gun clubs, and the creation of a firearms registry.

The changes introduced “onerous regulatory compliance,” said McKee, whose political party, Act, campaigned for New Zealand’s 2023 election on a platform for reversing many of them. Now in government as part of a center-right coalition, McKee pledged to update the law before the next election in 2026.

Her bloc has enough lawmakers to easily pass any reforms. Prime Minister Christopher Luxon and a spokesperson for Labour — New Zealand’s largest opposition party, formerly led by Ardern — have not answered AP requests for comment.

McKee said she would consult with the public before deciding specific measures and that her personal views would not direct the overhaul. Critics rejected that.

“She was elected as a gun lobbyist, that was her role,” said Chris Cahill, president of the Police Association, a group representing most New Zealand officers. “She’s got a loyalty to the gun lobby groups.”

The review was “without a doubt, a backdoor into giving people access to semiautomatic assault rifles again,” Cahill said.

At the time of the ban, McKee denounced it as “knee-jerk.” As a minister she is more guarded, but told the AP that New Zealand had not been entirely rid of such weapons; several hundred people have permits to use them for pest control in rural areas, while others can own but not fire them.

“If we extend the access, what are the possible controls around the use of the extension? And would society be happy with what those controls mean?” McKee said she would ask during the review.

“It’s about how do we find the balance with protecting people but not going over the top with a regulatory regime,” she said. Any concerns raised by opponents should be “realistic," McKee added. “It cannot be anecdotal.”

New Zealand’s gun laws were safer before the 2019 reforms, the minister said, citing the dozens of pages of information now required for a gun license as an example of changes that could deter gun owners’ compliance.

“That’s absolute rubbish,” said Cahill. Gun laws were “loose” before the terrorist attack, he added, and the scrutiny reported by owners in the years since reflected the proper administration of the law after an injection of government funds.

McKee will begin by examining the gun registry created after the attacks; some gun owners want it shrunk to only the highest-powered weapons, rather than all guns. She will also explore removing from police oversight the new agency that administers gun licenses and registrations.

Gun crime has increased in New Zealand since 2019, according to analysis of official crime figures by New Zealand news outlets. Supporters of the tighter restrictions say they will take time to have an impact, and that a burgeoning problem with violent gang crime is fueling the rise. McKee, and groups representing gun owners, say scrutiny since the attack has fallen on law-abiding license holders at the expense of criminals, who are not captured by the stricter rules.

The Council of Licensed Firearms Owners said members had lost or couldn't obtain licenses because of malicious reports from past partners — who must be interviewed as part of a person’s application — or because they had divulged depression to their doctors. Areas of flexibility should be introduced to applications, spokesperson Hugh Devereux-Mack said.

“Every single New Zealander who is not convicted of a serious criminal offense and has no sort of problematic behaviors or serious mental health conditions is eligible to own a firearm,” Devereux-Mack said.

The gunman serving a life sentence for the Christchurch attack, Brenton Tarrant, moved to New Zealand from Australia, acquired a gun license and amassed a cache of assault weapons, all legally, without drawing the attention of law enforcement until he committed the massacre.

The police were censured by an inquiry that found Tarrant was incorrectly allowed to nominate a character reference who barely knew him because he did not have relatives in New Zealand who could be interviewed.

McKee said the rules that followed have made the system rigid and unwieldy. She would prefer a licensing regime “that looked at the individual," she said — without prompting the same disregard of rules that had allowed Tarrant to receive a license.

Devereux-Mack said his group might support an additional practical testing component to gun licensing, and a tiered system with more freedoms for longtime license holders.

“New Zealand won’t be safer if it becomes easier to get a gun,” Ataçocuğu said. “I have to have an eye test every time I renew my drivers’ license. Gun owners should have similar background and mental health checks every few years to make sure they’re still safe to have guns.”

FILE - An armed policeman patrols the grounds at the Al Noor mosque following the previous week's mass shooting in Christchurch, New Zealand, on March 23, 2019. New Zealand’s government will overhaul the tighter gun laws introduced after a deadly mass shooting by a white supremacist five years ago, because they put excessive burdens on gun owners who feel vilified by law enforcement and the public, the lawmaker leading the changes said. (AP Photo/Mark Baker, File)

FILE - An armed policeman patrols the grounds at the Al Noor mosque following the previous week's mass shooting in Christchurch, New Zealand, on March 23, 2019. New Zealand’s government will overhaul the tighter gun laws introduced after a deadly mass shooting by a white supremacist five years ago, because they put excessive burdens on gun owners who feel vilified by law enforcement and the public, the lawmaker leading the changes said. (AP Photo/Mark Baker, File)

FILE - A police officer stands guard with a rose at the service for a victim of the March 15 mosque shootings at the Memorial Park Cemetery in Christchurch, New Zealand, on March 21, 2019. New Zealand’s government will overhaul the tighter gun laws introduced after a deadly mass shooting by a white supremacist five years ago, because they put excessive burdens on gun owners who feel vilified by law enforcement and the public, the lawmaker leading the changes said. (AP Photo/Vincent Yu, File);;;

FILE - A police officer stands guard with a rose at the service for a victim of the March 15 mosque shootings at the Memorial Park Cemetery in Christchurch, New Zealand, on March 21, 2019. New Zealand’s government will overhaul the tighter gun laws introduced after a deadly mass shooting by a white supremacist five years ago, because they put excessive burdens on gun owners who feel vilified by law enforcement and the public, the lawmaker leading the changes said. (AP Photo/Vincent Yu, File);;;

FILE - Police acting superintendent Mike McIlraith shows New Zealand lawmakers in Wellington on April 2, 2019, an AR-15 style rifle similar to one of the weapons a gunman used to slaughter 50 people at two mosques. New Zealand’s government will overhaul the tighter gun laws introduced after a deadly mass shooting by a white supremacist five years ago, because they put excessive burdens on gun owners who feel vilified by law enforcement and the public, the lawmaker leading the changes said.(AP Photo/Nick Perry, File)

FILE - Police acting superintendent Mike McIlraith shows New Zealand lawmakers in Wellington on April 2, 2019, an AR-15 style rifle similar to one of the weapons a gunman used to slaughter 50 people at two mosques. New Zealand’s government will overhaul the tighter gun laws introduced after a deadly mass shooting by a white supremacist five years ago, because they put excessive burdens on gun owners who feel vilified by law enforcement and the public, the lawmaker leading the changes said.(AP Photo/Nick Perry, File)

FILE - Armed police officers guard the entrance as family and survivors from the March 2019 Christchurch mosque shootings line up to enter the Christchurch High Court for day two of the sentencing hearing of Australian Brenton Harrison Tarrant, in Christchurch, New Zealand, on Aug. 25, 2020. New Zealand’s government will overhaul the tighter gun laws introduced after a deadly mass shooting by a white supremacist five years ago, because they put excessive burdens on gun owners who feel vilified by law enforcement and the public, the lawmaker leading the changes said. (AP Photo/Mark Baker, File)

FILE - Armed police officers guard the entrance as family and survivors from the March 2019 Christchurch mosque shootings line up to enter the Christchurch High Court for day two of the sentencing hearing of Australian Brenton Harrison Tarrant, in Christchurch, New Zealand, on Aug. 25, 2020. New Zealand’s government will overhaul the tighter gun laws introduced after a deadly mass shooting by a white supremacist five years ago, because they put excessive burdens on gun owners who feel vilified by law enforcement and the public, the lawmaker leading the changes said. (AP Photo/Mark Baker, File)

FILE- Al Noor mosque shooting survivor Temel Ataçocuğu points to the scar of a bullet wound in his arm during an interview at his home in Christchurch, New Zealand, on Feb. 25, 2020. New Zealand’s government will overhaul the tighter gun laws introduced after a deadly mass shooting by a white supremacist five years ago, because they put excessive burdens on gun owners who feel vilified by law enforcement and the public, the lawmaker leading the changes said. (AP Photo/Mark Baker, File)

FILE- Al Noor mosque shooting survivor Temel Ataçocuğu points to the scar of a bullet wound in his arm during an interview at his home in Christchurch, New Zealand, on Feb. 25, 2020. New Zealand’s government will overhaul the tighter gun laws introduced after a deadly mass shooting by a white supremacist five years ago, because they put excessive burdens on gun owners who feel vilified by law enforcement and the public, the lawmaker leading the changes said. (AP Photo/Mark Baker, File)

New Zealand's Associate Justice Minister Nicole McKee addresses a press conference at Parliament in Wellington, New Zealand, on April 22, 2024. McKee says the government will review stricter gun controls introduced after a mass shooting five years ago as part of a wide-ranging overhaul of firearms laws. (Mark Mitchell/New Zealand Herald via AP)

New Zealand's Associate Justice Minister Nicole McKee addresses a press conference at Parliament in Wellington, New Zealand, on April 22, 2024. McKee says the government will review stricter gun controls introduced after a mass shooting five years ago as part of a wide-ranging overhaul of firearms laws. (Mark Mitchell/New Zealand Herald via AP)

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