跳到主要内容

LED Medical Diagnostics Inc.宣布成功解决FDA警告信

  • 2016年1月13日
  • 新闻发布

温哥华,不列颠哥伦比亚省,2016年1月12日– LED Medical Diagnostics (“LED Medical” or “the Company”) subsidiary LED Dental is pleased to announce that it has received confirmation from the United States Food and Drug Administration (FDA) that it has adequately addressed the agency’s concerns outlined in a Warning Letter sent to the company dated May 12, 2014. This confirmation brings to a conclusion the negotiations between LED Dental and the FDA regarding certain marketing verbiage on the LED Dental website pertaining to the VELscope Vx system. LED Dental completed the requested changes to the website in December 2015 and received notification shortly thereafter that the changes were acceptable.

Dr. David Morgan, chief technology officer of LED Dental, remarked, “Although we felt justified in the language that we originally utilized, we also understand the agency’s position and, in the end analysis, do not feel that the FDA’s requested changes diminish in any way the compelling value proposition of the VELscope Vx communicated on our website.”

关于LED Medical Diagnostics Inc.

成立于2003年,总部位于加拿大不列颠哥伦比亚省(不列颠哥伦比亚省),LED医疗诊断公司的温哥华,通过其全资子公司LED牙科Inc.和LED牙科有限公司,提供先进的诊断成像产品和软件的牙医和口腔健康专家,此外金博188BETappios下载屡获殊荣的Velscope®VX组织荧光可视化技术。由经验丰富的领导团队支持,致力于更高的服务和支持,LED牙科致力于为牙科从业人员提供最佳技术,通过识别和添加领先的产品,以其越来越多的产品组合。金博188BETappios下载金宝搏188bet官方网站

该公司目前在符号“LMD”下的TSX-V上市,符号“LEDIF”下的OTCQX,以及法兰克福证券交易所在“LME”下。有关更多信息,请致电884.952.7327或访问www.leddental.com/investor-relerations.