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.
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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)
CALGARY, Alberta (AP) — Lauren Coughlin held onto the lead Friday in the CPKC Women’s Open, while Canadian star Brooke Henderson was derailed by closing bogeys at windy and smokey Earl Grey Golf Club.
Coughlin followed her opening 4-under 68 on Thursday in chilly and windy conditions with a 70 on Friday to get to 6 under, a stroke ahead of Hannah Green and Haeran Ryu. The temperature made it into the 70s after barely climbing into the 60s on Thursday.
“I think I handled it really well overall,” Coughlin said. “It was just really difficult to judge how far the ball was going to go with the wind and the crosswind and how firm the greens got. And they had some tough pins, especially considering the direction of the wind.”
Playing through a smokey haze from wildfires, Henderson bogeyed the final four holes in her afternoon round for a 73 that left her seven strokes back at 1 over. She won the 2018 tournament.
“Most of the day I was 3 under, so feeling pretty great,” Henderson said. “To walk away 1 over, that’s not the best feeling. But all you can do is move forward and try to learn from some of the things you did out there.”
Coughlin is coming off a fourth-place finish two weeks ago in France in the major Evian Champions. The 31-year-old former University of Virginia player is winless on the LPGA Tour.
On Friday, she had three front-none birdies and dropped a stroke on the par-4 11th. In two rounds, she's 7 under on the first nine holes and 1 over on the second nine.
“I putted extremely well,” Coughlin said. “Two-putted really well all day. Took advantage of the front nine, which you have to, and then kind of hold on on the back nine.”
Green matched Coughlin with a 70. The Australian is a two-time winner this year, taking the HSBC Women’s World Championship in Singapore in February and the JM Eagle LA Championship in April.
“It was tough again out there,” Green said. “There was some pretty strong wind gusts, especially our last few holes, so committing to the shot you were envisioning was kind of difficult.”
Ryu bogeyed the 18th for 69.
“The weather is really bad,” Ryu said. “Is a little bit cold and so windy.”
The 23-year-old South Korean player won the Walmart NW Arkansas Championship last year for her first LPGA Tour title. She was second last week in Ohio in the Dana Open.
Three-time champion Lydia Ko had a 71 to join second-ranked Lilia Vu (70) and Jennifer Kupcho (72) at 3 under. Ko won as an amateur in 2012 at age 15, successfully defended her title as an amateur in 2013 and won as a professional in 2015.
“It’s not easy — and I think the scores are showing,” Ko said. “Anything kind of under par the past couple days is a really solid round. I’m pretty happy with the way I started this week.”
Kupcho topped the leaderboard at 8 under after birdieing five of the first eight holes in her morning round, then was 5 over the rest of the way. She had a double bogey on the par-4 16th, four bogeys and a birdie on her final nine holes.
“I’m pretty upset,” Kupcho said. “I think in hindsight I still hit 15 greens. Like I was hitting the ball really good. Three-putted 10 and 11 and four-putted 16. I didn’t play bad. Just had a couple shaky putts down the stretch — and that’s going to happen.”
Lexi Thompson was in the group with Henderson tied for 26th at 1 over after a 73 The American plans to play a limited schedule after this season.
AP golf: https://apnews.com/hub/golf
Lexi Thompson, of the United States, chips on the first hole during the second round at the LPGA Canadian Women's Open golf tournament in in Calgary, Alberta, Friday, July 26, 2024. (Jeff McIntosh /The Canadian Press via AP)
Jennifer Kupcho, of the United States, watches her tee shot on the fifteenth hole during the second round at the LPGA Canadian Women's Open golf tournament in in Calgary, Alberta, Friday, July 26, 2024. (Jeff McIntosh /The Canadian Press via AP)
Jennifer Kupcho, of the United States, lines up a putt on the fourteenth green during the second round at the LPGA Canadian Women's Open golf tournament in in Calgary, Alberta, Friday, July 26, 2024. (Jeff McIntosh /The Canadian Press via AP)
New Zealand's Lydia Ko hits a tee shot on the first hole during the second round at the LPGA Canadian Women's Open golf tournament in in Calgary, Alberta, Friday, July 26, 2024. (Jeff McIntosh /The Canadian Press via AP)
Korea's Haeran Ryu hits a tee shot on the fourth hole during the second round at the LPGA Canadian Women's Open golf tournament in Calgary, Alberta, Friday, July 26, 2024. (Jeff McIntosh/The Canadian Press via AP)
Canada's Brooke Henderson hits a tee shot on the second hole during the second round at the LPGA Canadian Women's Open golf tournament in Calgary, Alberta, Friday, July 26, 2024. (Jeff McIntosh/The Canadian Press via AP)
Lauren Coughlin, of the United States, hits from the fairway on the sixth hole during the second round at the LPGA Canadian Women's Open golf tournament in Calgary, Alberta, Friday, July 26, 2024. (Jeff McIntosh/The Canadian Press via AP)
Lauren Coughlin, of the United States, hits a tee shot on the seventh hole during the second round at the LPGA Canadian Women's Open golf tournament in Calgary, Alberta, Friday, July 26, 2024. (Jeff McIntosh/The Canadian Press via AP)
