BOSTON, May 20, 2021 /PRNewswire/ -- Overjet, the global leader in dental artificial intelligence, today announced that it received FDA 510(k) clearance for its Overjet Dental AssistTM product. This Software as a Medical Device product applies artificial intelligence in real-time to aid dentists and hygienists. The clearance by the FDA will enable Overjet to market and sell the AI product directly to dental practices. The software supports dental professionals in measuring mesial and distal bone levels in bitewing and periapical radiographs for the diagnosis and treatment planning of periodontal disease. The condition affects an estimated 46 percent of U.S. adults, including 8.9 percent who have severe periodontitis. Left untreated, periodontitis can lead to tooth loss and painful chewing.
"Overjet's Dental Assist clearance by the FDA is a landmark moment for dental AI," said Dr. Wardah Inam, PhD, CEO and co-founder of Overjet. "All clinicians can now have at their fingertips highly accurate software to detect and measure serious dental disease and clear AI visualizations to communicate with patients. This is big for dentistry and moving toward evidence-based, patient-centric care."
In clinical performance testing, Overjet Dental AssistTM demonstrated automated measurement capabilities comparable to a team of highly skilled dentists. Overjet had three experienced dentists independently measure bone levels on dental radiographs using a measuring tool. These measurements were then further adjudicated by an oral radiologist to establish an official consensus ground truth. Overjet's AI-powered Dental Assist measurements were then compared against this dentist consensus and had an average difference of only 0.3mm.
"We're seeing dental AI software perform at the level of a team of trained dentists with accuracy closer than the width of a needle," said Dr. Chris Balaban, DMD, Clinical Director for Overjet. "These tools unlock the ability to track the progression of disease over time for each tooth and make the case for evidence-based treatment, supported by unbiased software and clear visuals for patients."
Three-year-old Overjet was founded by a team of PhDs and dentists from MIT and Harvard. They built the company around the mission of improving oral healthcare for all. To date, the company has raised over $10.5 million in venture funding and built artificial intelligence models to detect a variety of dental conditions such as cavities, gum disease, tartar and impacted teeth. Overjet's software is already in daily use by multiple large dental insurance companies to automate and improve the accuracy of dental claims review. The company has numerous partnerships with research institutions, dental support organizations and large dental practices.
Overjet is the global leader in dental artificial intelligence, helping both payers and providers improve patient care. Overjet's in-practice AI software bolts on to existing practice management software and is designed to help dentists deliver high-quality care, automate administrative tasks, and identify areas for growth. For more information, follow Overjet at www.overjet.ai and on LinkedIn and Twitter.
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波士顿2021年5月20日电/PRNewswire/--牙科人工智能领域的全球领导者Overjet公司今天宣布其Overjet dental AssistTM产品获得FDA 510(k)许可。该软件作为一种医疗器械产品，实时应用人工智能辅助牙医和卫生员。FDA的批准将使Overjet公司能够直接向牙科诊所销售和销售人工智能产品。该软件支持牙科专业人员在咬翼和根尖周X线片中测量近中和远端骨水平，用于牙周病的诊断和治疗计划。估计有46%的美国成年人患有牙周炎，其中8.9%患有严重牙周炎。如果不治疗，牙周炎会导致牙齿脱落和咀嚼疼痛。
在临床性能测试中，Overjet Dental AssistTM展示了与高技能牙医团队相媲美的自动化测量能力。Overjet让三名经验丰富的牙医使用测量工具在牙科X光片上独立测量骨骼水平。这些测量结果随后由一位口腔放射科医生进一步判定，以确定官方共识的基本事实。然后将Overjet的AI驱动的牙科辅助测量结果与牙医的共识进行比较，结果平均相差只有0.3mm。