FDA clears AI that predicts Alzheimer’s progression from an MRI scan

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 founder and CEO Padideh Kamali-Zare said in a statement.

BrainSee, which previously received a breakthrough designation from the FDA in 2021, delivers a quantitative score from 0 to 100, allowing for patients to be categorized by risk when considering potential treatment options. 

The program only requires a common 3D MRI scan, with no contrast injections, as well as cognitive test scores that are typically collected during a diagnostic workup. 

The San Francisco-based Darmiyan launched in 2016 and received funding from Y Combinator the year after. In 2020, a $6 million seed financing round was led by the Alzheimer’s-focused drugmaker Eisai, with additional backing from IT-Farm and Y Combinator.