Darmiyan's BrainSee, the inaugural FDA-cleared prognostic test for Alzheimer's disease likelihood prediction

15 January 2024

Darmiyan, a key player in brain health innovation, recently announced FDA clearance for its unique clinical trial of BrainSee (De Novo), aimed at addressing Alzheimer's disease. This approval marks a significant turning point in the fight against Alzheimer's, presenting advancements in brain health and opening up new possibilities in brain health diagnosis and management. Drawing on over 40 years of expertise in brain science, BrainSee utilizes advanced whole-brain imaging analysis and medical artificial intelligence technology, representing the first clinical application of Darmiyan's patented technology.

This platform, highly scalable and fully automated, incorporates standard clinical brain MRI cognitive assessment into routine non-invasive examinations for patients experiencing memory loss. It produces objective scores predicting the likelihood of progression from aMCI to Alzheimer's disease within a 5-year timeframe. BrainSee addresses the crucial need for over 10 million Americans and more than 100 million global patients dealing with aMCI, transforming the patient experience from chronic anxiety to proactive management. With the aging global population, BrainSee is poised to have a significant socioeconomic impact, potentially reducing healthcare costs associated with Alzheimer's disease through improved management and treatment options.

Having received FDA breakthrough therapy certification in 2021, BrainSee boasts accuracy in prognostic testing, patient convenience, same-day result access, and seamless integration into clinical workflows. Its global applicability is enhanced by the widespread use of MRI. Notably, BrainSee revolutionizes the aMCI examination paradigm, replacing invasive, non-specific, and costly biomarker methods with a non-invasive, actionable, and practical approach to forecasting future improvement or progress.

Source: prnewswire.com