FDA grants 510(k) clearance for Neural Analytics’ Lucid Ultrasound System

2 November 2016 (Last Updated November 2nd, 2016 18:30)

The US Food and Drug Administration (FDA) has given 510(k) clearance to Neural Analytics to market its next generation ultrasound device, the Lucid M1 Transcranial Doppler Ultrasound System (Lucid System).

The US Food and Drug Administration (FDA) has given 510(k) clearance to Neural Analytics to market its next generation ultrasound device, the Lucid M1 Transcranial Doppler Ultrasound System (Lucid System).

The Lucid System is a fully portable all-in-one ultrasound system for rapid triaging and monitoring of patients with brain disorders.

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 commercialise in the US.

“This is a significant milestone for our organisation, and more importantly, represents a step forward in improving the care of all patients suffering from blood flow disorders.”

The Lucid System analyses the brain’s blood vessels from outside the body using a type of ultrasound called Trans Cranial Doppler.

This non-invasive analysis can be performed in a physician’s office, thereby helping the diagnosis of brain disorders and eliminating the need of additional, invasive tests.

"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."

The Lucid System has been developed as a battery operated medical grade tablet device which can be moved easily across a medical facility in a range of settings that require the rapid assessment of blood flow in the brain in order to accelerate treatment.

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.

“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.”


Image: The Lucid M1 Transcranial Doppler Ultrasound System. Photo: courtesy of Business Wire.