Get in Touch

Introducing Our FDA Designated Breakthrough: BrainSee Enterprise Software for Prognostic Measurement after aMCI Diagnosis

Darmiyan is pleased to announce that the company’s first product BrainSee has obtained from the FDA a breakthrough designation granted for innovative medical devices. (If you already knew about our milestone from the AI in Healthcare list of notable technology approvals or other buzz, sign up now to join our inner circle.)

Darmiyan’s BrainSee enterprise software offers a prognostic measurement re: Alzheimer’s disease based on brain MRI and cognitive assessments after an aMCI diagnosis, which may be especially useful as you consider the opportunity offered by the newly approved Aduhelm. Through the breakthrough program FDA separately discerned BrainSee offers a distinct advantage over existing interventions in addressing and assessing debilitating or life-threatening diseases. 

Darmiyan’s company milestone follows journal publication and professional presentation about the success of our third-party validation study in partnership with US and Canadian hospitals and clinics.

With this recognition, we are committed to bringing BrainSee to market as soon as possible while ensuring its safety and efficacy for clinical and clinical trial use. To that end we are looking for research partners and coverage advisors to join our growing ecosystem of investors, medical network executives and academic data partners from ADNI, Stanford, and independent clinics.

For additional information about research opportunities or to express your interest in early adopter benefits, please reach out to Ilyse Veron, our head of US strategic partnerships at ilyse@darmiyan.com.

We look forward to helping you keep your research and practice on the cutting edge regarding diagnosis and prognosis of mild cognitive impairment and aim to help you offer the personalized, informative care your patients and their loved ones demand and deserve.

Regards,

CEO Padideh Kamali-Zare, PhD 

Chief Medical and Technology Officer Kaveh Vejdani, MD




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 and in May 2021 an FDA Breakthrough designation for BrainSee. 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 using brain MRI is patented in the US; patents are pending in Europe, Japan and China.

Key Takeaways
  • Darmiyan is pleased to announce that the company’s first product BrainSee has obtained from the FDA a breakthrough designation granted for innovative medical devices.
  • Through the breakthrough program FDA separately discerned BrainSee offers a distinct advantage over existing interventions in addressing and assessing debilitating or life-threatening diseases.
  • Darmiyan’s BrainSee enterprise software offers a prognostic measurement re: Alzheimer’s disease based on brain MRI and cognitive assessments after an aMCI diagnosis, which may be especially useful as you consider the opportunity offered by the newly approved Aduhelm.
Related Bios
Padideh Kamali-Zare
CEO
View Full Bio>>
Kaveh Vejdani
Chief Medical and Technology Officer
View Full Bio>>
Media Gallery
Video Gallery
Darmiyan's One Minute Video Won a MedTech Innovator Award
Download
Contacts
Ilyse Veron
ILYSE@DARMIYAN.COM
Head of US Strategic Partnerships