Medical Applications

Clinical Study - Digital Mammography

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AIE conducted its second clinical study in the fall of 2005 with six physicians participating from four hospitals including Brigham and Women's Hospital, Newton-Wellesley Hospital (host site), Massachusetts General Hospital and Faulkner Hospital to demonstrate and clinically validate the benefits of AIE enhancement for digital mammography. The results of this second study were extremely positive. Researchers concluded that the AIE image enhancement software:

  • Consistently improves the conspicuity and detail of abnormalities
  • Increases Radiologists' confidence in coming to their conclusions
  • Has shown to improve clarity in images with dense breast tissue

FDA Clearance

Subsequent to the conclusion of the clinical study in late 2005, AIE filed a 510k (Premarket Notification) application with the Food and Drug Administration (FDA). The Company received clearance from the FDA in September, 2006 to market the technology.

Digital Mammography Product Launch

Hologic, Inc. entered into a licensing agreement with AIE and has integrated the AIE image enhancement software with the Hologic SecurView Radiology Workstation for the screening and diagnosis of breast cancer. Product launch for the AIE image enhancement technology will occur in the 4th quarter of year 2009 with Hologic.

Chest X-ray

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AIE has also developed image enhancement algorithms for chest x-rays. Chest image enhancement provides physicians with significantly improved image clarity and detail for both bone and soft tissue screening and diagnosis.