Miro Health receives Breakthrough Device designation from the FDA

Miro Health has been granted breakthrough device designation by the Food and Drug Administration (FDA) for its mobile, self-administered, neurobehavioral assessment technologies.


FDA's Breakthrough Device Program is reserved for innovative medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This program is intended to help patients receive timely access to these medical devices by expediting their development, assessment, and review by the FDA.


Miro Health's assessment technologies have been clinically-validated and findings have been submitted to peer-reviewed journals. Miro Health's research platform is currently used in clinical studies and clinical trials for mild cognitive impairment, dementing disorders, depression, stroke, cancer, and traumatic brain injury. Miro Health's automated healthcare platform is beginning early use with Payers and Providers, and is currently only available in combination with Miro Health's clinical care providers.


Miro Health, a privately-held digital healthcare and medical device company headquartered in San Francisco, CA, develops proprietary technologies to provide specialty neurobehavioral healthcare to broad populations by combining its innovative design, A.I., and machine learning with its new healthcare economic model.

Recent Posts

See All

Solving the neurological puzzle of COVID-19

Miro Health and Johns Hopkins have teamed up to investigate how COVID-19 affects the brain. Doctors on the frontlines of COVID-19 have been reporting unusual symptoms ranging from loss of smell and ne