Neural Analytics Receives FDA Clearance
November 1, 2016
The Lucid™ M1 Transcranial Doppler Ultrasound System (Photo: Business Wire) LOS ANGELES–(BUSINESS WIRE)–Neural Analytics Inc., a medical device company developing technology to measure, diagnose and track brain health, today announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its next generation ultrasound device, the Lucid™ M1 Transcranial Doppler Ultrasound System (Lucid System). The Lucid System is the first FDA cleared fully portable all-in-one ultrasound system designed for rapid triaging and monitoring of patients with brain disorders. The system is the first product that Neural Analytics will sell commercially. “Neural Analytics’ Lucid System is the first truly portable ultrasound system to assess brain blood flow, and is the first product we will commercialize in the United States,” said Leo Petrossian, Chief Executive Officer of Neural Analytics. “This is a significant milestone for our organization, and more importantly, represents a step forward in improving the care of all patients suffering from blood flow disorders.” |
