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Spectral MD Announces 510(k) Clearance by the FDA for DeepView™ Medical Imaging System


Spectral MD Announces 510(k) Clearance by the FDA for DeepView™ Medical Imaging System
Dallas, TX, June 13, 2013 --(PR.com)-- Spectral MD™ (“Spectral MD” or “The Company”), a medical device imaging company, announces the DeepView™ Medical Imaging System has received 510(k) clearance from the U.S. Food and Drug Administration for studies of blood flow in microcirculation. The DeepView™ system is suitable for a wide variety of clinical applications including plastic surgery, diabetes, dermatology, vascular surgery, wound healing, neurology, physiology, neurosurgery and anesthetics.

DeepView™ is a portable device that produces images by extracting physiologic information from the interaction of light with the body. This digital analysis of optical signatures allows clinicians to look deeper into the body by delivering images of blood flow under the skin's surface without ever touching the patient. Spectral MD’s imaging solution is a non-invasive technology, uses no harmful radiation such as X-rays, and its portability allows for access to patients in most patient care environments.

Integrating the DeepView™ technology into a multitude of care facilities will produce a substantial benefit to the healthcare sector by dramatically reducing the overall cost to government and private insurers in the area of dermal wound care through early detection of debilitating conditions.

“Spectral MD is happy to see momentum in its regulatory pathway after receiving notice that the DeepView™ system was cleared for sales in the US. We are getting a great deal of support from clinicians in a variety of specialties and this clearance will facilitate integration of the technology into these areas. As this occurs we expect to identify areas where our unique diagnostic capabilities can enhance patient care, and this milestone will help us team with physicians to do this at a much more rapid pace.” –Will Rosellini, CEO

Spectral MD is a recipient of $1.5 million in funding from the National Science Foundation (NSF). The Company was awarded the highly competitive Small Business Innovation Research Phase II grant from the NSF in March of 2011.

“Our initial investment in the The DeepView™ imaging system was based on the promise that this technology could change outcomes from patients, not only is this a groundbreaking advancement but will also be great cost-reducer for insurers. I’m delighted at the news that DeepView™ was cleared by the FDA for US sales.” – Audrey Spangenberg , Chairman

About Spectral MD™:
Spectral MD is a high technology systems company founded to make fundamental contributions to the improvement of healthcare delivery, operations and patient outcomes. Spectral MD’s solutions bring together advanced optical systems with machine learning algorithms to enable physiologically based patient imaging systems. For more information about Spectral MD and the team, please visit the website at www.spectralmd.com.
Contact Information
Spectral MD
Will Rosellini, CEO
(972) 494-4934
Contact
www.spectralmd.com

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