Fierce Biotech January 12, 2024
The FDA has granted a de novo clearance to an artificial intelligence program capable of reading a standard brain MRI scan and predicting a patient’s chances of progressing from mild cognitive impairment and early memory loss to Alzheimer’s disease and dementia within five years, according to the software’s developer Darmiyan.
Described as a virtual microscope, the BrainSee prognostic program could be implemented before a positron emission tomography (PET) scan, which requires injections of radioactive tracers, or instead of biopsies of cerebrospinal fluid, the company said.
“Our vision is to redefine brain health screening and monitoring standards and impact the lives of patients and their family members in a meaningful way,” Darmiyan...
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