Thermimage Receives Premarket Notification [510(k)] Guidance from the FDA

October 24, 2007 (Salt Lake City, Utah) – Thermimage Inc received guidance from the Food and Drug Administration to submit for premarket notification [510(k)] for the Thermaflux Scanner prior to marketing the device. Any device that reaches market via a 510(k) notification must be “substantially equivalent” to a device on the market prior to May 28, 1976 (a “predicate device”). If a device being submitted is significantly different, relative to a pre-1976 device, in terms of design, material, chemical composition, energy source, manufacturing process, or intended use, the device nominally must go through a pre-market approval, or PMA. The 510(k) path for a new device typically allows a company to reach the market much quicker than with the PMA path.

Thermimage Inc was founded in February 2007 to commercialize a non-invasive, painless and less costly way to produce deep-tissue temperature measurements. The device will first be used to diagnose Vesicoureteral Reflux (VUR) in children, a dangerous condition that allows urine to backflow into the kidneys of young children. The current procedure is painful and requires the use of catheters and ionizing radiation, where this new technique will heat the contents of the bladder and then detect any increase in temperature in the kidneys signaling reflux.

image
image
image