Smart Soft gets FDA clearance for CoLumbo software

By AuntMinnieEurope.com staff writers

July 22, 2022 -- Smart Soft Healthcare of Bulgaria has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for CoLumbo, an image postprocessing and measurement application that provides quantitative measurements from MR images of the lumbar spine.

CoLumbo is designed to support review, analysis, and interpretation of lumbar MR images. It includes functionality that supports feature segmentation, feature measurement, threshold-based labeling of out-of-range measurement, and export of measurement results to a written report.

Smart Soft noted that the FDA clearance is an important milestone in the company's planned expansion into the U.S. market. In Europe, CoLumbo has been tested in three European hospitals and recently received the CE Mark.


Copyright © 2022 AuntMinnieEurope.com
 

To read this and get access to all of the exclusive content on AuntMinnieEurope.com create a free account or sign-in now.

Member Sign In:
MemberID or Email Address:  
Do you have a AuntMinnieEurope.com password?
No, I want a free membership.
Yes, I have a password:  
Forgot your password?
Sign in using your social networking account:
Sign in using your social networking
account: