FDA Cleared & Important Safety Information

Details

Published on Wednesday, 28 February 2018 12:22

Written by Alex Mostovoy

Caution: The United States Food and Drug Administration has cleared breast thermal imaging as an adjunct (complement) test to breast screening, and diagnostic imaging studies (such as Mammography, MRI, or Ultrasound), and recommends that patients follow the recommendations of their healthcare provider for routine screenings as well as for diagnostic imaging and/or additional work-up.

For further information see Title 21, Chapter 1, Part 884, Subpart C, Section 884.2980(a) of the United States Code of Federal Regulations