A San Francisco-based brain imaging analytics company, Darmiyan, has announced that its AI-based memory loss prediction software, BrainSee, has received FDA approval. This marks the first time that such software has been approved by the US government.
BrainSee is a software platform that uses clinical brain MRIs and cognitive tests to predict the likelihood of progression from amnestic mild cognitive impairment (aMCI) to Alzheimer’s dementia within a period of five years. By analyzing the imaging and cognitive assessments, the software assigns an objective score that indicates the patient’s odds of memory deterioration.
According to Darmiyan, this new technology has the potential to transform the patient experience, shifting it from prolonged anxiety to proactive management. Early treatment can be provided to those who are at risk, while others can be reassured and given peace of mind. The company believes that BrainSee will not only improve patient care but also have a significant economic impact on the healthcare industry. By enabling more effective management and treatment, the software promises to reduce the billions of dollars spent on Alzheimer’s care annually.
The FDA approval of BrainSee comes under the “De Novo” designation, which means that the product has no clear market predecessors but has proven its effectiveness and safety through clinical trials. Earlier this year, the software received FDA “breakthrough” designation, which is a significant milestone in the approval process for first-of-its-kind treatments.
Darmiyan emphasizes that BrainSee is a fully automated system that provides results on the same day that scans and cognitive test scores are entered. The company sees this technology as a shift in the treatment of mild/early cognitive decline, moving away from biomarker-based methods and towards non-invasive and actionable forecasts of future improvement or progression.
This FDA approval highlights the growing use of AI in healthcare and the potential it holds for improving early diagnosis and treatment outcomes for neurodegenerative diseases. The availability of BrainSee offers a promising step forward in predicting memory loss and facilitating timely interventions.
The source of the article is from the blog be3.sk