Neural Analytics said today that it won CE Mark approval in the European Union for its NeuralBot ultrasound guidance device for evaluating blood flow in the brain.
Los Angeles-based Neural Analytics said that NeuralBot is designed to work with its already-CE Marked Lucid M1 transcranial doppler utrasound to provide non-invasive blood flow monitoring.
“We are committed to advancing brain healthcare through transformative technology that empowers neurologists with the critical information needed to make clinical decisions and improve patient outcomes,” co-founder & CEO Leo Petrossian said in prepared remarks. “Our products provide clinicians with a cost effective and non-invasive assessment of a patient’s brain health, and can help clinicians diagnose brain disorders, potentially without the need for more invasive testing.”
“This technology allows us to look inside the brain, evaluate blood flow characteristics and track emboli in patients. It provides us with critical information on brain health in real-time to help us diagnose neurological disorders, prior to the need for additional, more invasive testing,” added Dr. Claudio Baracchini of Italy’s University of Padua.
Neural Analytics said it plans to immediately commercialize NeuralBot alongside the Lucid M1 in Europe under the Lucid Robotic System brand, which already won 510(k) clearance from the FDA.
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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