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LED Medical Diagnostics Inc. Announces Successful Resolution to FDA Warning Letter

  • January 13, 2016
  • News Releases

Vancouver, British Columbia, January 12, 2016 – 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.”

About LED Medical Diagnostics Inc.

Founded in 2003 and headquartered in Vancouver, British Columbia, Canada, LED Medical Diagnostics Inc., through its wholly-owned subsidiaries LED Dental Inc. and LED Dental Ltd, provide dentists and oral health specialists with advanced diagnostic imaging products and software, in addition to the award-winning VELscope® Vx tissue fluorescence visualization technology. Backed by an experienced leadership team and dedicated to a higher level of service and support, LED Dental is committed to providing dental practitioners with the best technology available by identifying and adding leading products to its growing portfolio.

The Company is currently listed on the TSX-V under the symbol “LMD”, the OTCQX under the symbol “LEDIF”, as well as the Frankfurt Stock Exchange under the symbol “LME”.  For more information, call 884.952.7327 or visit www.leddental.com/investor-relations.

Investor Relations:

MZ Group
Mike Cole
Phone: 949.444.1341
Email: mike.cole@mzgroup.us

Media Contact:

LED Dental
Chris Koch
Phone: 678.293.9413
Email: chris.koch@leddental.com

Corporate Contact:

LED Medical
David Gane, CEO
Phone: 604-434-4614 x227
Email: david.gane@leddental.com

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