First-of-its-kind tool creates new FDA category
Rochester, N.Y., June 9, 2015–Cerebral Assessment Systems Inc. has received U.S. Food and Drug Administration (FDA) approval for the Cognivue® cognition assessment aid. The Cognivue is the first-of-its-kind computer-based tool developed to better assess, measure and monitor brain function with the goal of detecting the early signs of late-life cognitive decline that may lead to dementia. The assessment, which is reimbursable, can be conveniently administered in any exam room or primary care office by office staff under the supervision of licensed practitioners.
Cognivue received de novo approval, meaning there exists no substantially equivalent device. To accurately classify Cognivue, the FDA created a new class of medical devices, designated Cognitive Assessment Aids (FDA Category: 882.1470). The approval allows Cerebral Assessment Systems to begin large-scale production and marketing of Cognivue.
Cognivue makes the assessment of cognitive function affordable, accurate and widely accessible. The assessment is safe, quick (about 10 minutes) and non-invasive, with the person being tested only needing to grasp the response device. The equipment is highly affordable for physicians in independent practices as well as those affiliated with medical groups. More information is available at cerebralassessmentsystems.com.
“The Cognivue is an important step forward in the detection and monitoring of cognitive decline,” said Charles Duffy, M.D., Ph.D., Cognivue inventor and Founder and CEO of Cerebral Assessment Systems. “It is our goal to make cognitive assessment as common as having your blood pressure checked at your annual physical.”
The early detection of cognitive impairment using Cognivue will allow practitioners and patients to better understand cognitive health and begin treatment earlier, if needed. The de novo designation validates the need for the tool. Before the approval of Cognivue, most physicians lacked a practical method to detect the early stages of cognitive decline. This has long been an obstacle to progress for dementia patients.
“We know that cognitive decline is a primary concern of the 70 million Americans 65 years old or older. However, cognitive assessment is currently cumbersome and practiced primarily at medical centers in major cities,” said Duffy. “Cognivue can bring such assessment to every corner of the country. We forecast a significant market for the Cognivue, but we believe there is an even greater opportunity to make a difference in the lives of patients.”
About Cognivue
The Cognivue cognitive assessment aid stemmed from National Institutes of Health (NIH)-funded basic research in cognitive neurology. The Cognivue is non-invasive and non-intrusive; the only direct contact with patients is through their manipulation of a one-handed steering wheel called a manipulandum. Patients watch an automated presentation of computer-generated displays with varying features and turn the manipulandum to indicate the location of the designated feature. More information is available at cerebralassessmentsystems.com.
About Cerebral Assessment Systems, Inc.
Cerebral Assessment Systems, Inc. was established in 2005 by Charles Duffy, M.D., Ph.D., a researcher and professor in Neurology, Ophthalmology , Neurobiology and Brain and Cognitive Sciences at the University of Rochester (New York) Medical Center.
Rochester, N.Y., June 9, 2015–Cerebral Assessment Systems Inc. has received U.S. Food and Drug Administration (FDA) approval for the Cognivue® cognition assessment aid. The Cognivue is the first-of-its-kind computer-based tool developed to better assess, measure and monitor brain function with the goal of detecting the early signs of late-life cognitive decline that may lead to dementia. The assessment, which is reimbursable, can be conveniently administered in any exam room or primary care office by office staff under the supervision of licensed practitioners.
Cognivue received de novo approval, meaning there exists no substantially equivalent device. To accurately classify Cognivue, the FDA created a new class of medical devices, designated Cognitive Assessment Aids (FDA Category: 882.1470). The approval allows Cerebral Assessment Systems to begin large-scale production and marketing of Cognivue.
Cognivue makes the assessment of cognitive function affordable, accurate and widely accessible. The assessment is safe, quick (about 10 minutes) and non-invasive, with the person being tested only needing to grasp the response device. The equipment is highly affordable for physicians in independent practices as well as those affiliated with medical groups. More information is available at cerebralassessmentsystems.com.
“The Cognivue is an important step forward in the detection and monitoring of cognitive decline,” said Charles Duffy, M.D., Ph.D., Cognivue inventor and Founder and CEO of Cerebral Assessment Systems. “It is our goal to make cognitive assessment as common as having your blood pressure checked at your annual physical.”
The early detection of cognitive impairment using Cognivue will allow practitioners and patients to better understand cognitive health and begin treatment earlier, if needed. The de novo designation validates the need for the tool. Before the approval of Cognivue, most physicians lacked a practical method to detect the early stages of cognitive decline. This has long been an obstacle to progress for dementia patients.
“We know that cognitive decline is a primary concern of the 70 million Americans 65 years old or older. However, cognitive assessment is currently cumbersome and practiced primarily at medical centers in major cities,” said Duffy. “Cognivue can bring such assessment to every corner of the country. We forecast a significant market for the Cognivue, but we believe there is an even greater opportunity to make a difference in the lives of patients.”
About Cognivue
The Cognivue cognitive assessment aid stemmed from National Institutes of Health (NIH)-funded basic research in cognitive neurology. The Cognivue is non-invasive and non-intrusive; the only direct contact with patients is through their manipulation of a one-handed steering wheel called a manipulandum. Patients watch an automated presentation of computer-generated displays with varying features and turn the manipulandum to indicate the location of the designated feature. More information is available at cerebralassessmentsystems.com.
About Cerebral Assessment Systems, Inc.
Cerebral Assessment Systems, Inc. was established in 2005 by Charles Duffy, M.D., Ph.D., a researcher and professor in Neurology, Ophthalmology , Neurobiology and Brain and Cognitive Sciences at the University of Rochester (New York) Medical Center.
