CuraCloud Receives FDA Clearance for ICH Triage Solution

by | Apr 14, 2020 | Press

SEATTLE, Wash., April 14, 2020 — CuraCloud Corporation announced April 13, 2020, that its computer aided triage and notification system for early recognition of intracranial hemorrhage (ICH) from head CT scans has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). CuraRad-ICH is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute ICH. CuraRad-ICH analyzes cases using deep learning algorithms to identify suspected ICH findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage purposes.

Intracranial hemorrhage is a life-threatening condition in which internal bleeding occurs inside the brain. ICH is the second most common subtype of stroke with a high case fatality rate (40% at 1 month). CuraCloud, along with its collaboration partners, developed the CuraRad-ICH software medical device to process the digital output from CT scans soon after acquisition so that images in which this condition is found can be appropriately prioritized by the radiology worklist systems within hospitals and diagnostic radiology practices. Worklist prioritization can help speed the reading of such urgent findings by radiologists so that appropriate care decisions can be made.
“CuraRad-ICH was trained and validated on CT images collected from more than 300 imaging facilities located in almost all states in the U.S., so we have high confidence in its performance accuracy and its applicability to the U.S. population,” said Dr. Xiaoxiao Liu, CuraCloud Director of Products and Strategic Development. “It only takes the core AI engine about 20 seconds per case on average to do the inferencing step leveraging the GPU capabilities.”
This is CuraCloud’s first FDA clearance. The company is actively developing a portfolio of AI-enabled software medical devices for use in the U.S. and other parts of the world.

About CuraCloud Corporation

CuraCloud is a medical AI R&D company developing software medical devices and providing professional services to medical technology vendors, healthcare organizations, and pharmaceutical companies. Founded in 2016, CuraCloud works with medical device manufacturers and healthcare delivery organizations to bring advances in machine learning and medical informatics to benefit patients and those who care for them.

This resource was first published prior to the 2020 rebranding of CuraCloud to Keya Medical. The content reflects our legacy brand.