The FDA has reportedly approved an AI product that predicts cognitive decline

BrainSee assigns a score forecasting the advancement of memory loss within five years.

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The US government has reportedly approved AI-based memory loss prediction software for the first time. Darmiyan, a San Francisco-based brain imaging analytics company, says the FDA has granted De Novo approval for its product BrainSee. The software platform assigns “an objective score that predicts the likelihood of progression from aMCI to Alzheimer’s dementia within 5 years,” according to the medical company. Fierce Biotech first reported the announcement.

Darmiyan says BrainSee can predict memory loss progression using clinical brain MRIs and cognitive tests, which are already standard for patients worried about early signs of decline. After the program analyzes the imaging and cognitive assessments, it assigns a predictive score indicating the patient’s odds of memory deterioration within the following five years. At least in theory, that would lead to early treatment for some and peace of mind for others.

“This shifts the patient experience from prolonged anxiety to proactive management, which is crucial in an era of emerging Alzheimer’s treatments where accurate prognosis can help determine suitable treatment candidates,” Darmiyan wrote in a press release announcing the FDA approval. “The economic impact of BrainSee will be significant for all stakeholders in healthcare, promising to reduce the billions of dollars annually spent on Alzheimer’s care, through more effective management and treatment.”

The FDA’s “De Novo” designation means the product has no clear market predecessors but has proven its effectiveness and safety in clinical trials. BrainSee first received FDA “breakthrough” designation in 2021, an earlier stage of the approval path for a first-of-its-kind treatment.

Darmiyan says BrainSee is fully automated and provides results on the same day the scans and cognitive test scores are entered. The company views the tech as shifting the treatment of mild / early cognitive decline from biomarker-based methods to “non-invasive and actionable forecasts of future improvement or progression.”