BrainSee provides a score that predicts how quickly memory loss will progress over the next five years.
The United States government has reportedly given its approval for the first time to artificial intelligence-based memory loss prediction software. According to Darmiyan, a company that specializes in brain imaging analytics and is based in San Francisco, the Food and Drug Administration has given its product BrainSee De Novo approval. The software platform is responsible for determining “an objective score that predicts the likelihood of progression from aMCI to Alzheimer’s dementia within 5 years,” as stated by the medical company. In the beginning, the announcement was reported by Fierce Biotech.
It is possible, according to Darmiyan, for BrainSee to forecast the progression of memory loss by employing clinical brain MRIs and cognitive tests, which are already commonplace for patients who are concerned about early signs of decline. When the program has finished analyzing the imaging and cognitive assessments, it will then assign a predictive score to the patient. This score will indicate the likelihood that the patient will experience a decline in their memory within the next five years. In theory, that would result in early treatment for some people and peace of mind for others. At the very least, that can be said.
“This shifts the patient experience from prolonged anxiety to proactive management,” Darmiyan wrote in a press release announcing the FDA approval. “This is crucial in an era of emerging Alzheimer’s treatments where accurate prognosis can help determine suitable treatment candidates,” Darmiyan emphasised in the release. “The economic impact of BrainSee will be significant for all stakeholders in the healthcare industry, with the promise of reducing the billions of dollars that are spent annually on Alzheimer’s care through more effective management and treatment,”
A product is considered “De Novo” by the Food and Drug Administration (FDA) if it has not been shown to have any clear market predecessors, but it has demonstrated its efficacy and safety in clinical trials. In 2021, BrainSee was granted the “breakthrough” designation by the Food and Drug Administration (FDA), which is an earlier stage in the approval process for a treatment that is the first.
According to Darmiyan, BrainSee is completely automated and delivers results on the same day that the scans and cognitive test scores are entered. The company believes that the technology will allow for the treatment of mild or early cognitive decline to shift away from biomarker-based methods and toward “non-invasive and actionable forecasts of future improvement or progression.”