Spectral MD Gains FDA Clearance for Imaging Device

Dallas, Texas-based Spectral MD Inc., a medical imaging technology company, has received 510(k) clearance from the U.S. Food and Drug Administration for its Deepview medical imaging system. The system is designed to study blood flow in microcirculation (in the smallest blood vessels). Deepview is designed for use in 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, claims the company. According to the company, the system is non-invasive, uses no harmful radiation such as X-rays, and its portability allows for access to patients in most patient care environments.

Company officials also hope the device is well positioned to help lower healthcare costs 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 United States,” said Will Rosellini, CEO of Spectral. “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.”

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 2011.

“Our initial investment in the Deepview imaging system was based on the promise that this technology could change outcomes from patients,” said Spectral Chairwoman Audrey Spangenberg. “Not only is this a groundbreaking advancement but will also be great cost-reducer for insurers.”