Neural Analytics, Inc. Receives CE Mark for its Robotic Ultrasound System
Product News Jun 19, 2018
Neural Analytics, Inc., a medical robotics company developing and commercializing technologies to measure and track brain health, announced that it received CE Mark for its NeuralBot™ System, a robotic assistance technology which automatically adjusts orientation and position of its ultrasound products under the guidance of a healthcare professional. When used with its previously cleared Lucid™ M1 Transcranial Doppler Ultrasound System®, it can assist clinicians to non-invasively monitor a patient’s brain blood flow characteristics and can provide information to diagnose a variety of neurological disorders.
“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,” said Prof. Dr. Claudio Baracchini, MD, FESO, Director of the Stroke Unit and Neurosonology Lab at the University of Padua (Italy) and President of the European Society of Neurosonology and Cerebral Hemodynamics (ESNCH).
In April, at the 23rd ESNCH Meeting in Prague, Neural Analytics presented research data that demonstrated there was no statistical difference between ultrasound blood flow data collected with its NeuralBot™ System or data collected manually by an expert technician with its traditional ultrasound platform.
“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,” said Leo Petrossian, Ph.D., Co-Founder and Chief Executive Officer of Neural Analytics. “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.”
The worldwide prevalence of stroke in 2010 was 33 million cases, with 16.9 million people having their first stroke. Stroke claims a life every five seconds and is the second most common cause of death accounting for over 11.9 percent total deaths worldwide. The burden of disease caused by stroke is set to double worldwide by 2030. The number of stroke events in Europe is projected to rise from 1.1 million to 1.5 million per year by 2025. Stroke is a time sensitive disease and requires intervention within 24 hours of onset of symptoms. Incorrect assessment of large vessel stroke leads to misdiagnosis and treatment delays, resulting in death or disability for stroke patients. Despite recent advances in life-saving treatments for acute ischemic stroke, less than five percent of stroke patients qualify for intervention because they do not present early enough.
Neural Analytics will immediately commercialize the NeuralBot™ System with its currently available Lucid M1 TCD System® in Europe as the ‘Lucid™ Robotic System’ and has also received 510(k) clearance from the Food and Drug Administration as well.