FDA OKs Infrared Sciences' BreastScan IT system

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Infrared Sciences Corp. has received FDA 510(k) approval for its BreastScan IR technology.

The non-invasive system utilizes digital infrared imaging technology to assist physicians in the early detection of breast cancer. Physicians determine breast health by measuring various temperature parameters in the breast. These measurements are compared to measurements in BreastScan's IR large database, to determine overall breast health relative to known cases.

The entire procedure takes approximately 10 minutes and patients are not exposed to any radiation.

The company says that the system is not intended to replace conventional mammography or ultrasound; rather it is intended as an adjunctive procedure. The system draws attention to areas that may not have been detected by standard mammograms, including those areas beneath dense breast tissues that mammograms cannot image.

Additionally, it can localize areas that can be further investigated using ultrasound technology.

Infrared Sciences says that several medical facilities have tested BreastScan IR for more than four years as an adjunct for mammography and ultrasound, such as Arena Oncology in Great Neck, N.Y. and Long Island Diagnostic Imaging in Setauket, N.Y.