Three times the charm when it comes to Zebra Medical. The Kibbutz Shefayim, Israel-based company has managed to win its third FDA clearance – this time for its artificial intelligence-based technology.
The company’s technology is named HealthICH, which is an AI alert for intracranial hemorrhage.Zebra Med's intracranial hemorrhage triage solution can provide early detection of people who may have experienced a brain bleed.
The algorithm is comprised of a, tailor-made neural network architecture designed to identify intracranial hemorrhage while tackling several challenges, such as relatively small bleed sizes and common artifacts (metal, motion artifacts) seen within the brain.
"We are thrilled to get a third nod from FDA in such a short time and to be able to add such an important new finding to our growing AI1 "all-in-one" package" Eyal Gura, Zebra-Med's CEO, said in a release.
This is the second FDA clearance for Zebra Med’s Multi-Modality AI Triage Solutions, which was received in May 2019 and focused on HealthPNX - an AI alert for pneumothorax, based on chest X-rays, enabling it to be the world's first AI chest x-ray triage product.
Zebra Med’s first FDA clearance, received in July of 2018, focuses on coronary calcium scoring, which can be an early sign for coronary artery disease.