FDA: BrainSee Novel Software Is Breakthrough for Noninvasive Detection and Monitoring of Alzheimer's Disease at the Early Stage of Mild Cognitive Impairment

San Francisco, California--(Newsfile Corp. - May 28, 2021) - FDA has granted breakthrough status to BrainSee, a new AI-powered product by Darmiyan Inc. Using standard, non-invasive clinical brain MRI (no injection and no radiation), BrainSee detects Alzheimer's disease at the early prodromal stage, enabling timely medical interventions and care planning. Such early detection or rule-out of Alzheimer's disease non-invasively and affordably is nonexistent in the clinical market today.

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Key Takeaways:

• FDA has granted breakthrough status to BrainSee, a new AI-powered product by Darmiyan Inc. that detects Alzheimer's disease at the early prodromal stage. The company's AI solution has learned from more than 200 physicians following thousands of MCI and AD patients for decades.
• Using standard, non-invasive clinical brain MRI (no injection and no radiation), BrainSee detects Alzheimer's disease at the early stage of mild cognitive impairment, enabling timely medical interventions and care planning.
• Breakthrough recognition of BrainSee by FDA will facilitate the development of therapeutics and interventions that can fill the clinical gaps for patients with memory concerns. BrainSee enables the selection of those patients for clinical trials who are at the very early stages of neurodegeneration, and will benefit most from treatments that can potentially stop disease progression, slow it down, or reverse brain damage.

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Based in San Francisco, California, Darmiyan was incorporated in September 2016 and backed by Y-Combinator (YC) in Summer 2017. The Company has won numerous awards and recognitions including the TEDMED Hive Innovator in 2018, CABHI Innovation Award in 2019 and Fortune 40 Under 40 for healthcare in 2020. Darmiyan joined the Women's Health Innovation Coalition in 2021. Darmiyan's most recent funding in 2020 was led by the global pharma giant Eisai with participation of YC and IT-Farm. Darmiyan's proprietary technology is patented in the US; patents are pending in Europe, Japan and China.

Contacts:

Ilyse Veron
ILYSE@DARMIYAN.COM

Source: Darmiyan

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