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Neural Analytics gets FDA approval for new brain monitoring information system

Neural Analytics has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its next generation Lucid M1 transcranial doppler ultrasound system.

The company has developed new portable all-in-one ultrasound system for rapid triaging and monitoring of patients with brain disorders.

The system is a battery operated medical grade tablet device, which can be easily moved across the medical facility in a range of settings that require the rapid assessment of blood flow in the brain.

Lucid system, which can be used in the physician’s office, will enable physician to diagnose brain disorders without using more invasive tests.

Through using trans cranial doppler, the Lucid system will evaluate blood vessels of the brain from outside the body.

Most of the brain disorders such as severe traumatic brain injury (TBI) will take place due to disruption of blood flow.

Neural Analytics CEO Leo Petrossian said: “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.

“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.”

Neural Analytics chief medical officer Neil Martin said: “The Lucid system offers the ability to accurately measure the flow of blood in the brain, which is critical to assess and monitor patients suspected of severe brain conditions.”

In October, the firm commenced the clinical study to assess next generation portable diagnostic platform for early detection of stroke.

The company will recruit around 150 patients who are suspected of having a large vessel occlusion (LVO) stroke and determine whether its technology will assist clinicians in more rapidly assessing stroke risk in the emergency room setting.


Image: The Lucid M1 transcranial doppler ultrasound system. Photo: courtesy of Business Wire.