FDA Approves Robotic Technology to Aid in Neurological Diagnoses

The US Food and Drug Administration (FDA) has approved a robotic technology that assists clinicians in non-invasive monitor of patient brain blood flow characteristics, and provides diagnostic information for a variety of neurological disorders.

The NeuralBot, from Neural Analytics, received FDA 510(k) clearance on Wednesday, pairing the device with the company’s Lucid M1 Transcranial Doppler Ultrasound System to provide new lengths of robotic-assisted care for neurological patients.

The approval was backed by recent data from Neural Analytics which demonstrated no found statistical difference between ultrasound blood flow data collected by the NeuralBot System or data collected manually by an expert technician using a traditional ultrasound platform.

The device is also projected to make a difference in costs of care. According to Neural Analytics, neurological diseases costs the US health care system nearly $800 billion annually — with traumatic brain injury, migraine, Alzheimer’s disease, and stroke comprising more than half those costs.

Particularly for conditions such as stroke, which affects almost 800,000 people in the US, time is critical in response to symptoms. Less than 5% of stroke patients qualify for intervention because they do not present symptoms early enough, with an abundance of incorrect large vessel stroke assessments eventually leading to misdiagnosis or treatment delay.

Robert Hamilton, PhD, co-founder and chief scientific officer of Neural Analytics, said progress in treating neurological disorders has lagged due to a lack of available low-cost and objective patient diagnostic information.

“This has resulted in misdiagnosis, treatment delays and additional healthcare expenditures for patients suffering neurological disease,” Hamilton said. “Our new technology can assist a healthcare professional — when an expert technician is not available — with the collection of blood flow data to assist clinicians in efficiently triaging patients for appropriate treatment.”

The company intends to immediately commercialize the NeuralBot System with the approved ultrasound system as a combined “Lucid Robotic System,” which, when used for for a transcranial doppler ultrasound procedure for patients who may have neurological conditions, is reimbursable by Medicare, Medicaid, and most private payers.