DentalMonitoring Sets New Standard In Orthodontic Remote Monitoring With De Novo Approval By the U.S. Food and Drug Administration (FDA).
May 20 2024 - 3:16PM
Business Wire
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240520240852/en/
Celine Cendras-White Head of Marketing Communication +33 18 695
0101 public-relations@dental-monitoring.com