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

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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).

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.

Texas Supreme Court halts execution of man in shaken baby case after lawmakers' last-minute appeal

2024-10-18 11:45 Last Updated At：11:51

HUNTSVILLE, Texas (AP) — The Texas Supreme Court halted Thursday night’s scheduled execution of a man who would have become the first person in the U.S. put to death for a murder conviction tied to a diagnosis of shaken baby syndrome.

The late-night ruling to spare for now the life of Robert Roberson, who was convicted of killing his 2-year-old daughter in 2002, capped a flurry of last-ditch legal challenges and weeks of public pressure from both Republican and Democratic lawmakers who say he is innocent and was convicted based on flawed evidence.

For hours on Thursday night, Roberson had remained in a prison holding cell a few feet from America's busiest death chamber at the Walls Unit in Hunstville.

"He praised God and thanked supporters,” said Texas Department of Criminal Justice spokesperson Amanda Hernandez, who spoke with Roberson after the court stayed his execution.

Although Texas' highest court normally does not weigh in on criminal cases, how it got involved in Roberson's case in the final hours underlined the extraordinary maneuvers used by a bipartisan coalition of state House lawmakers who have come to his defense.

Blocked by courts and Texas' parole board in their efforts to spare Roberson's life, legislators on Wednesday took a different route: issuing a subpoena for Roberson to testify before a House committee next week, days after he was scheduled to die by lethal injection.

Less than two hours before Roberson's execution, a judge in Austin granted the lawmakers an order upholding the subpoena, putting the execution on pause. An appeals court then briefly reversed that decision but was overruled by the high court's order.

“We're deeply grateful to the Texas Supreme Court for respecting the role of the Texas legislature in such consequential matters," Democratic Rep. Joe Moody and Republican Rep. Jeff Leach wrote in a joint statement.

Roberson, 57, was convicted of killing of his daughter, Nikki Curtis, in the East Texas city of Palestine. His lawyers and some medical experts say his daughter died not from abuse but from complications related to pneumonia.

Gov. Greg Abbott had authority to delay Roberson’s punishment for 30 days. Abbott has halted only one imminent execution in nearly a decade as governor and has not spoken publicly about the case.

Earlier Thursday, the U.S. Supreme Court refused to halt the execution, although Justice Sonia Sotomayor — in a 10-page statement about the case — urged Abbott to grant a 30-day delay.

Roberson’s lawyers had waited to see if Abbott would grant Roberson a one-time 30-day reprieve. It would have been the only action Abbott could take in the case as the Texas Board of Pardons and Paroles on Wednesday denied Roberson’s clemency petition.

The board voted unanimously, 6-0, to not recommend that Roberson’s death sentence be commuted to life in prison or that his execution be delayed. All board members are appointed by the governor. The parole board has recommended clemency in a death row case only six times since the state resumed executions in 1982.

The one time Abbott halted an imminent execution was when he spared the life of Thomas Whitaker in 2018.

The Texas committee on Wednesday held an all-day meeting on Roberson's case. In a surprise move at the end of the hearing, the committee issued a subpoena for Roberson to testify next week.

During its meeting in Austin, the committee heard testimony about Roberson’s case and whether a 2013 law created to allow people in prison to challenge their convictions based on new scientific evidence was ignored in Roberson’s case.

Anderson County District Attorney Allyson Mitchell, whose office prosecuted Roberson, told the committee a court hearing was held in 2022 in which Roberson’s attorneys presented their new evidence to a judge, who rejected their claims.

“Based on the totality of the evidence, a murder took place here. Mr. Roberson took the life of his almost 3-year-old daughter,” Mitchell said.

Most of the members of the committee are part of a bipartisan group of more than 80 state lawmakers, including at least 30 Republicans, who had asked the parole board and Abbott to stop the execution.

Roberson’s case has renewed debate over shaken baby syndrome, known in the medical community as abusive head trauma.

His lawyers as well as the Texas lawmakers, medical experts and others including bestselling author John Grisham say his conviction was based on faulty and now outdated scientific evidence. The diagnosis refers to a serious brain injury caused when a child’s head is hurt through shaking or some other violent impact, like being slammed against a wall or thrown on the floor.

Roberson’s supporters don’t deny head and other injuries from child abuse are real. But they say doctors misdiagnosed Curtis’ injuries as being related to shaken baby syndrome and that new evidence has shown the girl died from complications related to severe pneumonia.

Roberson’s attorneys say his daughter had fallen out of bed in Roberson’s home after being seriously ill for a week.

Roberson’s lawyers also suggested his autism, then undiagnosed at the time of his daughter’s death, was used against him as authorities became suspicious of him because of his lack of emotion over her death. Autism affects how people communicate and interact with others.

Follow Juan A. Lozano on X at https://x.com/juanlozano70.