The US Food and Drug Administration (FDA) has cleared the NeuralBot System (Neural Analytics Inc) to noninvasively assess abnormal blood flow in the brain.
The robotic assistance ultrasound technology is designed to help physicians diagnose, triage, and manage patients who present with vasospasm, acute ischemic stroke, and other neurologic disorders characterized by abnormal blood flow.
The approval is based on research that shows no statistical difference between ultrasound blood flow data collected with NeuralBot System and data collected manually by five expert technicians using traditional ultrasound in a study presented at the European Society of Neurosonology and Cerebral Hemodynamics (ESNCH) 2018 conference. The investigators concluded that the robotic assistance technology compares well to technician assessment, even when brain pathology requires subtle morphologic analysis.
“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,” Robert Hamilton, PhD, co-founder and chief scientific officer of Neural Analytics, said in a release. “Our new technology can assist a healthcare professional when an expert technician is not available…in efficiently triaging patients for appropriate treatment,” he added.
The American Heart Association/American Stroke Association's "Guidelines for the Early Management of Patients With Acute Ischemic Stroke" state that detection of large vessel occlusion by means of noninvasive intracranial vascular imaging greatly improves the ability to make appropriate clinical decisions (Stroke. 2013;44:870-947).
Following the 510(k) clearance, the company plans to make the NeuralBot System immediately commercially available in the United States as part of its previously approved Lucid M1 Transcranial Doppler Ultrasound System. Medicare, Medicaid, and many private insurers provide reimbursement for diagnoses made by using the Lucid Robotic System, according to the release.
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Cite this: FDA Okays Robotic System to Detect Abnormal Brain Blood Flow - Medscape - May 30, 2018.