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

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.

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
The founding CEO of Darmiyan, Padideh is a 2020 Fortune 40 under 40 global healthcare leader/ influencer, and a 2018 TEDMED Hive Innovator. She has been leading the Company for the past 5 years, taking the technology through multiple stages of development, from conception to a functioning product. Under her leadership, Darmiyan team has achieved widespread recognition in the biomedical and life science communities, through numerous awards and partnerships. Padideh is a world-renowned geometrical modeling expert with an outside-the-box thinking approach to complex problems. Her major skill is to put things into context and visualize the big picture (story-telling). Prior to starting Darmiyan, she was an Adjunct Assistant Professor at New York University, School of Medicine, where she previously completed three years of postdoctoral training in biophysical neuroscience, 2010-2013, under supervision of Professor Charles Nicholson, the scientific father of brain microstructure modeling. Padideh got her PhD in biological physics from Royal Institute of Technology (KTH) in Stockholm, Sweden in 2010. Her PhD thesis entitled “Biophysical mechanisms underlying cellular homeostasis” provided a non-classical explanation for the relationship between cell structure and function. In her free time Padideh enjoys teaching Persian classical music and writing blogs, including the Psychology Today
series on Cognitive Future.
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Kaveh Vejdani
Chief Medical and Technology Officer
Kaveh is a nuclear medicine physician, sub-specialized in PET/CT and PET/MR from Stanford University and NYU Langone Medical Center. He has been a savvy computer programmer since the age of 13, coding numerous projects in computational mathematics, physical simulations, and medical image processing.
Kaveh received his MD degree in 2003 and performed his postdoctoral research at UCSF, followed by clinical specialty training in nuclear medicine at St. Louis University. His professional experience ranges from tissue engineering (stem cells and biomaterials) to radiology and molecular imaging. In his free time, Kaveh enjoys playing violin and chess and making iPhone apps.


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Contacts

Ilyse Veron
ILYSE@DARMIYAN.COM
Head of US Strategic Partnerships