The United States has granted approval to a unique AI-based software that can predict the development of cognitive impairment. San Francisco-based company Darmiyan has received De Novo approval from the US Food and Drug Administration (FDA) for its Brainsee product. This program can determine the likelihood of transitioning from mild cognitive impairment to Alzheimer’s disease within a span of five years. The announcement was initially made by Fierce Biotech.
Brainsee utilizes magnetic resonance imaging (MRI) data of the brain and the results of cognitive tests, which are already part of the standard diagnosis for individuals concerned about the early signs of mental decline. The software analyzes this information and generates a prognostic rating. This approach not only facilitates early intervention and treatment, but also provides reassurance to individuals who fall into the low-risk category.
In a press release, representatives from Darmiyan emphasized the transformative impact of this innovation on patients, enabling them to shift from constant anxiety to conscious control of their health. They stressed the significance of accurate forecasting in choosing the most suitable treatment options in the era of advancing Alzheimer’s disease research. Additionally, they highlighted that Brainsee has the potential to significantly reduce the financial costs associated with patient care, which amount to billions of dollars annually.
FDA grants De Novo approval to products that are unique in the market and have demonstrated their effectiveness and safety in clinical trials. In 2021, Brainsee was designated as a “Breakthrough technology” by the FDA, marking an important milestone on its path to complete approval.
The Brainsee program is fully automated and provides results on the same day as the medical scans and tests. Its introduction to the market signifies a shift from traditional biomarker-dependent methods to more advanced and effective approaches.