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Market Sectors Granted De Novo FDA Clearance for First Artificial Intelligence Triage Software

SAN FRANCISCO, Feb. 15, 2018 --, Inc., an applied artificial intelligence healthcare company announced that the U.S. Food and Drug Administration (FDA) has granted a De Novo request for the first-ever Computer-Aided Triage and Notification Platform to identify Large Vessel Occlusion (LVO) strokes in CTA imaging. This regulatory clearance compliments's recent European CE Mark for the product in January 2018.

"The LVO Stroke Platform is the first example of applied artificial intelligence software that seeks to augment the diagnostic and treatment pathway of critically unwell stroke patients," said Dr. Chris Mansi, neurosurgeon and Chief Executive Officer. "We are thrilled to bring artificial intelligence to healthcare in a way that works alongside physicians and helps get the right patient, to the right doctor at the right time."

Stroke is a serious and time-sensitive medical condition that requires emergency care and can cause lasting brain damage, long-term disability and death. A stroke occurs if the flow of oxygen-rich blood to a portion of the brain is blocked. When this happens 2 million brain cells die every minute. "This software device could benefit patients by notifying a specialist earlier thereby decreasing the time to treatment. Faster treatment may lessen the extent or progression of a stroke," said Robert Ochs, Ph.D., acting deputy director for radiological health, Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health.

The LVO Stroke Platform was developed using deep learning, a revolutionary technique where algorithms learn how to identify patterns in data from millions of prior examples. The system connects to a hospital CT scanner and alerts the stroke specialist that a suspected LVO stroke has been identified, sending the radiological images directly to their smart phone.

In a 300-patient performance study, the LVO Stroke Platform obtained an AUC of 0.91, identifying LVOs and alerting the relevant specialist with 90% sensitivity and specificity and a median scan to notification time of under 6 minutes. In over 95% of cases, the automatic notifications demonstrated faster notification of the specialist, saving between 6 and 206 minutes, with an average time saving of 52 minutes.

"Timely LVO stroke identification and transfer to a specialist hospital that can perform mechanical thrombectomy is the top priority for LVO stroke patients," said Dr. Raul Nogueira, Professor of Neurology, Neurosurgery and Radiology at Emory University and the Immediate-Past President, Society of Vascular & Interventional Neurology. "This software is designed to help identify appropriate patients earlier and more often, and enable faster transfer and treatment, which, ultimately may result in improved patient outcomes." 

About Stroke

Stroke is a leading cause of permanent disability, death and healthcare costs globally. In the U.S., someone has a stroke every 40 seconds and someone dies from a stroke every 4 minutes. Each year, nearly 800,000 people in the U.S. have a stroke costing the U.S. health system more than $34 billion each year, including health care services, medications and lost productivity.

About, Inc., Inc. is an applied artificial intelligence healthcare company that works alongside physicians to improve acute medical care. The LVO Stroke Platform leverages advanced deep learning to communicate time-sensitive information about patients straight to a specialist who can intervene and treat., Inc., based in San Francisco and Tel Aviv, is financially backed by former Google CEO Eric Schmidt's venture capital firm, Innovation Endeavors and by Danhua Capital (DHVC). is the first company to receive FDA clearance for an Artificial intelligence based Computer-Aided Triage and Notification System.

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