www.fdanews.com/articles/187593-zebra-medical-vision-cleared-for-brain-bleed-algorithm
Zebra Medical Vision Cleared for Brain Bleed Algorithm
July 12, 2018
The FDA granted 510(k) clearance to Zebra Medical Vision’s AI imaging algorithm for intracranial hemorrhaging detection.
The algorithm will be included in the company’s Deep Learning Imaging Analytics platform, which can analyze CT data for signs of fatty liver, emphysema, low bone density and other conditions.
The algorithm is intended to be used for point of care detection and worklist prioritization, allowing physicians to more accurately and speedily detect brain bleeds.