FDA clears medical robotics, analytics to spot stroke

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A company developing medical robotics products to measure blood flow to the brain has received clearance from the Food and Drug Administration to market a technology that can assist providers in cost-effectively triaging patients for treatment.

The technology from Neural Analytics—combining the use of ultrasound and digital information systems—is expected to assist emergency personnel at healthcare organizations as they assess patients for potential medical issues such as stroke, which affects 795,000 people in the U.S. annually.

The company received 510(k) clearance for its NeuralBot System, a robotic assistance technology that automatically adjusts orientation and position of its ultrasound products, under the guidance of a healthcare professional.

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The company contends that the NeuralBot System, used with its previously FDA-approved Lucid M1 Transcranial Doppler Ultrasound system, can help clinicians non-invasively monitor a patient’s blood flow and provide information to assist in diagnosing specific medical conditions.

Quick diagnosis of the specific problem is essential in beginning treatment as soon as possible—that’s because stroke is a time-sensitive disease and requires intervention within 24 hours of onset of symptoms.

“Progress in treating neurological disorders has lagged due to a lack of available low-cost and objective patient diagnostic information,” says Robert Hamilton, co-founder and chief scientific officer of Neural Analytics. “This has resulted in misdiagnosis, treatment delays and additional healthcare expenditures for patients suffering neurological disease. 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.”

Incorrect assessment of large vessel stroke leads to misdiagnosis and treatment delays, resulting in death or disability for stroke patients. Despite recent advances in life-saving treatments for acute ischemic stroke, fewer than five percent of stroke patients qualify for intervention because they do not present for treatment early enough, narrowing the window that emergency professionals have for diagnosing the specific brain issue and beginning correct treatment.

The American Heart Association and American Stroke Association Guidelines for Early Management of 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.

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