Third FDA clearance for Zebra-Med's AI solution for brain bleeds alerts

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Third FDA clearance for Zebra-Med's AI solution for brain bleeds alerts

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KIBBUTZ SHEFAYIM, Israel, June 17, 2019 /PRNewswire/ -- Zebra Medical Vision, the deep learning medical imaging analytics company, announces today that it has received its third FDA 510(k) clearance for the company's HealthICH product - an AI alert for intracranial hemorrhage (ICH), based on head CT scans.

The latest cleared product automatically identifies suspected internal brain bleeds based on non-contrast head CTs for triaging, significantly reduces turnaround time, and increases the radiologists' confidence in their diagnosis. The overall Multi-Modality AI Triage Solution by Zebra-med, is a first of its kind in the market that provide alerts for both CT scans and X-rays, and currently addresses two acute conditions: intracranial hemorrhages (head CTs), and pneumothorax (chest X-rays), which also received FDA clearance in the past month. Both Triage solutions and others, such as the FDA cleared calcium scoring product, are part of the AI1 "all-in-one" bundle that provides hospitals with a growing amount of AI tools at a fixed annual price and consistent service and support.

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Intracranial hemorrhage accounts for about 10% to 20% of all strokes, and can occur as a result of traumatic injury (falls, crashes etc), ruptured arteries (aneurysms), stroke or cancer. It can result from injury within a vein or artery, or a combination of the two. Regardless of the cause, the timely and accurate diagnosis of active bleeding is essential for the successful care of these patients. Intracranial hemorrhage, or the common phrasing - brain bleed, is a devastating disease, with a high 30-day mortality rate that ranges from 35% to 52%. It is estimated that about 50% of this mortality occurs within the first 24 hours, emphasizing the importance of early detection and effective treatment in the Emergency Department.

The financial impact of early detection would be enormous given the fact that stroke cost the U.S. alone $34 billion annually, including the cost of healthcare services, medications, and lost productivity. The overall incidence of spontaneous ICH worldwide is 24.6 people in every 100,000 , with approximately 40,000 to 67,000 cases per year in the United States.

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 unique, 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.
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