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FDA greenlights Neural Analytics' NeuralBot System

by John R. Fischer , Staff Reporter
Using blood flow in the brain to assess the risk of stroke may now be more accessible following FDA clearance for Neural Analytics Inc.’s NeuralBot System.

Combined with the Lucid M1 Transcranial Doppler Ultrasound system, the robotic assistance solution enables healthcare professionals in the company of a neurologist to noninvasively evaluate changes in blood flow and emboli, and the reaction of brain tissue to these changes, to assess stroke or detect the risk of it and other neurological conditions.

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“A patient may show up at a hospital and be recommended to receive a transcranial doppler ultrasound,” Robert Hamilton, co-founder and chief scientific officer at Neural Analytics, told HCB News. “Unfortunately, the expert technician may no longer be there or the hospital doesn’t provide coverage. The use of the Neuralbot system allows for a healthcare professional, accompanied by a neurologist who can read the information, to perform and get that information without the need for an expert stenographer.”

Incorrect assessments of large vessel stroke often lead to misdiagnoses and treatment delays, which heighten the chances of death or disability. Many of these cases are due to the lack of available low-cost and objective patient diagnostic information, and can burden patients with additional healthcare expenditures.

Equipped with system review, spectrogram editing and PDF reporting, the Lucid M1 TCD System processes a doppler signal in twice the resolution of legacy equipment and offers a platform for analysis of the complete waveform spectrum.

The Neuralbot System pairs with the Lucid M1 Transcranial Doppler Ultrasound to form the Lucid Robotic system which acts as an advanced probe for neurological assessment by assisting in the set up and acquisition of the data that is collected on the Lucid system. Neuralbot enables automatic adjustment in orientation and position of the ultrasound product under the guidance of a healthcare professional.

Information is then interpreted by a clinician for diagnosis, treatment or changes in management. A recent evaluation found no difference in the use of the Neuralbot System for assessing blood flow data, compared to manual collection by an expert technician with a traditional ultrasound platform.

Hamilton says the dual combination of both technologies provides neurologists with additional information they may not have and enables greater access to necessary care for patients with neurological conditions.

“Just increasing access to this technology gives them the ability to perform these measures when they need to, allowing them to have that information to provide the clinical care that the guidance calls for,” he said.

More than 795,000 people suffer strokes in the U.S., with one occurring every 40 seconds and killing a person every four minutes. Such events, along with traumatic brain injury, migraine, and Alzheimer's account for more than $438 billion of the $800 billion incurred by the U.S. healthcare system annually due to neurological disorders.

The Neuralbot system will be made available with the Lucid M1 TCD system which is also FDA cleared. The Lucid Robotic system is reimbursable by Medicare, Medicaid and most private payers.

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