FDA clears Neural Analytics’ next-gen portable brain monitoring system

Neural Analytics scored an FDA nod for its fully portable ultrasound system for the quick and noninvasive diagnosis of brain disorders, such as traumatic brain injury (TBI).

The Lucid System is a battery-operated tablet device that is designed with mobility in mind. It can be moved rapidly through a medical facility and can be used to rapidly measure blood flow to the brain and speed up treatment, according to a statement. Blood flow disruption can cause multiple types of brain disorders, including severe TBI. The idea is for first responders and emergency room physicians to assess the damage early, when it is most important to act quickly.

Lucid uses a type of ultrasound known as transcranial Doppler, which measures the speed of blood flow through the brain’s blood vessels. It does this by measuring the echoes of ultrasound waves traveling through the skull. Transcranial Doppler can help physicians diagnose brain disorders, potentially without requiring further, more invasive tests, Neural Analytics said in the statement.

“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,” said Dr. Neil Martin, chief medical officer of Neural Analytics and chief of neurosurgery at the University of California, Los Angeles. “Thanks to the portability of the product, for the first time, clinicians will be able to bring this level of care directly to the patient prior to the need for more complex and invasive tests.”

The device will be Neural Analytics’ first commercialized product. It has the potential to expedite and improve treatment for a “vast majority” of the 2.5 million Americans who suffer a traumatic brain injury each year.

Neural Analytics picked up $3 million in NIH funding in September to bankroll a clinical validation study of the device. In December 2015, it snagged $10 million in Series A funding to drive clinical testing and development of the platform.