Artificial Intelligence healthcare developer Viz.ai said this week it won approval from the FDA for its LVO Stroke platform designed to analyze computed tomography results and notify providers of potential strokes, touting it as the first such system to win FDA clearance.
The company’s LVO Stroke platform is designed using deep learning and connects to a hospital CT scanner to alert stroke specialists that a suspected LVO stroke has been identified, with the ability to send radiological images directly to the physician’s phones.
“Timely LVO stroke identification and transfer to a specialist hospital that can perform mechanical thrombectomy is the top priority for LVO stroke patients. 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,” Dr. Raul Nogueira of Emory University said in a prepared statement.
“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,” FDA Center for Devices and Radiological Health’s radiological health acting deputy director Robert Ochs said in a prepared release.
Approval came supported by a 300-patient performance study of the system, with results indicating an AUC of 0.91, a 90% sensitivity to identifying LVOs and alerting specialists, and a median scan to notification time of under 6 minutes.
Results also indicated that automatic notifications saved an average of 52 minutes in over 95% of cases.
“The Viz.ai 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. 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,” CEO Dr. Chris Mansi said in a press release.
Viz.ai said it won CE Mark approval in the European Union for the system in January.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
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