MYNDBLUE has received FDA Breakthrough Device Designation

Transforming
mental health

Because mental health matters every day

MENTAL HEALTH IS A GLOBAL CRISIS

Depression is in dire need of new solutions

#1

cause of disability

in the U.S.1 worldwide.2
0 M

people worldwide are struggling 

with different types of depression1. 21M struggling with major depressive disorder (MDD) in the U.S. alone.2
60%

increase in U.S. depression

within the last decade, with experts anticipating that this trend will continue upwards.3

DUE TO HIDDEN RISKS,

Up to 70% of Patients Fail to Recover from MDD4

Hidden Risks of MDD Patients
50%
discontinue treatment5
0 %
are lost to clinical monitoring6
80%
experience symptom reappearance7
Risks of MDD
0
suicides each year8 45% of whom had met with a clinician 30 days prior, unfortunately, to no avail9
24.4%
of people are readmitted to hospitals within 6 months10
A MAJOR UNMET NEED

PTSD Carries a Heavy Burden for All Involved.

~13M

Americans live with PTSD

in a given year.11

$ 0 B
annual economic burden of PTSD in the U.S.

including direct healthcare costs and lost productivity.12

1 in 4
patients diagnosed with PTSD drop out of treatment

highlighting the need for more accessible solutions.13

OUR SOLUTION

Objective, medical-grade, continuous depression severity monitoring to accurately anticipate and validate daily mental health changes for better patient outcomes.
1

Captures Biosignals
Continuously

A medical-grade wearable
designed specifically for mental health.

There are 100+ objective biosignal-derived features connected to mental health, but clinicians do not have the medical-grade tools to make sense of the noise.

2

Analyzes Biosignals
Objectively

Proprietary, AI-powered algorithm
creates a unique patient-specific biosignature to provide patient-specific insights.

Each patient is impacted by each of the 100+ biosignals differently and needs personalized care.

3

PROVIDES MEDICAL-GRADE
INSIGHTS

Medical-grade intelligence reports that show clinicians how patients are really doing between medical appointments.

MYNDBLUE’s continuous monitoring platform allows clinicians to gain a deeper understanding of their patients’ daily depression severity scores (i.e., mental health)—even when they are not in the office; MYNDBLUE supports real-time clinical decision-making inside and outside the clinician’s office.

PUBLICATIONS & NEWS

Military Health System Research Symposium (MHSRS) 2024

Distinguishing PTSD and non PTSD in military population in the breakout session applications of AI in psychological disorders.

Press Releases

MYNDBLUE announces that it has received FDA Breakthrough Device Designation.

MYNDBLUE announces the publication in Scientific Reports.

Publications

Our Latest Article about NODEs
Our Latest White Paper
Our Scientific Reports Article in MDD
Our Scientific Reports Article in PTSD
Our Latest Article in PTSD

Regulatory disclaimer: MyndBlue’s solution has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). Breakthrough Device designation is intended to facilitate the development and expedited review of certain medical devices and does not constitute FDA approval, clearance, authorization, or permission to market or commercialize the device. The solution has not received FDA marketing authorization and is currently not available for investigational or commercial use in the US.

  1. https://www.nimh.nih.gov/health/statistics/major-depression
  2. https://www.who.int/fr/news-room/fact-sheets/detail/depression
  3. https://www.cdc.gov/nchs/pressroom/releases/20250416.html
  4. American Psychiatric Association. (2010). Treating major depressive disorder: A quick reference guide. Washington, DC: American Psychiatric Association, 1-28.
  5. Dunner, D. L., Blier, P., Keller, M. B., Pollack, M. H., Thase, M. E., & Zajecka, J. M. (2007). Preventing recurrent depression: Long-term treatment for major depressive disorder. Journal of Clinical Psychiatry, 68(4), 619-630.
  6. Greenberg, P., Chitnis, A., Louie, D., Suthoff, E., Chen, S. Y., Maitland, J., … & Kessler, R. C. (2023). The economic burden of adults with major depressive disorder in the United States (2019). Advances in Therapy, 40(10), 4460-4479.
  7. Solomon, D. A., Keller, M. B., Leon, A. C., Mueller, T. I., Lavori, P. W., Shea, M. T., … & Endicott, J. (2000). Multiple recurrences of major depressive disorder. American Journal of Psychiatry, 157(2), 229-233.
  8. https://www.cdc.gov/suicide/data/index.html
  9. Luoma, J. B., Martin, C. E., & Pearson, J. L. (2002). Contact with mental health and primary care providers before suicide: a review of the evidence. American Journal of Psychiatry, 159(6), 909-916.
  10. Lin, J., Szukis, H., Sheehan, J. J., Alphs, L., Menges, B., Lingohr-Smith, M., & Benson, C. (2019). Economic burden of treatment-resistant depression among patients hospitalized for major depressive disorder in the United States. Psychiatric research and clinical practice, 1(2), 68-76.
  11. https://www.ptsd.va.gov/understand/common/common_adults.asp
  12. Davis, L. L., Schein, J., Cloutier, M., Gagnon-Sanschagrin, P., Maitland, J., Urganus, A., … & Houle, C. R. (2022). The economic burden of posttraumatic stress disorder in the United States from a societal perspective. The Journal of clinical psychiatry, 83(3), 21m14116-21m14116.
  13. Penix-Smith, E. A., & Swift, J. K. (2025). The protocol matters: A meta-analysis of psychotherapy  dropout from specific PTSD treatment approaches in US service members and veterans. Psychological Trauma: Theory, Research, Practice, and Policy.