TOBY Receives FDA Breakthrough Device Designation for Its Urine-Based Alzheimer's Disease Diagnostic Test
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3 Articles
FDA Grants Breakthrough Designation to Urine-Based Alzheimer’s Test
The test uses urinary volatile organic compound patterns and machine learning to aid in the diagnosis of Alzheimer’s disease. TOBY Inc announced that the Food and Drug Administration (FDA) granted Breakthrough Device Designation to its urine-based Alzheimer’s disease diagnostic test. The designation recognizes the potential of the TOBY Test for Alzheimer’s Disease to aid in diagnosis through a non-invasive urine sample, addressing a need for acc…
TOBY Receives FDA Breakthrough Device Designation for Its Urine-Based Alzheimer's Disease Diagnostic Test
TOBY, Inc., a biotechnology company developing non-invasive disease detection technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the TOBY Test for Alzheimer's Disease.
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