In a Dental Industry First, Overjet's Dental Assist Receives FDA Clearance to Bring AI to the Dental Practice

首先在牙科行业,Overjet的牙科辅助设备获得FDA的许可,将人工智能应用于牙科实践

2021-05-21 19:30:07 BioSpace

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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. About Overjet 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. View original content to download multimedia:http://www.prnewswire.com/news-releases/in-a-dental-industry-first-overjets-dental-assist-receives-fda-clearance-to-bring-ai-to-the-dental-practice-301295927.html SOURCE Overjet
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。 Overjet公司首席执行官兼联合创始人瓦尔达·伊纳姆博士说:“Overjet公司的牙科辅助设备获得FDA的批准是牙科AI的一个里程碑。“现在,所有临床医生都可以在指尖上拥有高精度的软件来检测和测量严重的牙病,以及清晰的AI可视化图像来与患者交流。这对于牙科以及向以证据为基础、以患者为中心的护理方向发展是非常重要的。” 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。 “我们看到牙科AI软件在一个训练有素的牙医团队的水平上表现得比针头的宽度还要精确,”Overjet的临床主任、DMD克里斯·巴拉班博士说。“这些工具释放了追踪每颗牙齿随时间的疾病进展的能力,并为基于证据的治疗提供了支持,同时为患者提供了无偏见的软件和清晰的可视化图像。” 成立三年的Overjet是由麻省理工学院和哈佛大学的博士和牙医组成的团队创建的。他们围绕着为所有人改善口腔保健的使命建立了公司。到目前为止,该公司已经筹集了超过1050万美元的风险投资,并建立了人工智能模型来检测各种牙齿状况,如蛀牙、牙龈疾病、牙石和阻生牙。Overjet的软件已经在多家大型牙科保险公司的日常使用中,用于自动化和提高牙科索赔审查的准确性。该公司与研究机构、牙科支持组织和大型牙科诊所有众多的合作伙伴关系。 关于覆盖 Overjet是牙科人工智能领域的全球领先者,帮助支付者和提供者都改善患者护理。Overjet的实践中的AI软件连接到现有的实践管理软件上,旨在帮助牙医提供高质量的护理,自动化管理任务,并确定增长领域。欲了解更多信息,请访问Overjet网站www.Overjet.ai以及LinkedIn和Twitter。 查看原始内容下载多媒体:http://www.prnewswire.com/news-releases/in-a-dental-industry-first-overjets-dental-assist-receives-FDA-clearance-to-bring-ai-to-the-dental-practice-301295927.html 震源覆盖

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