Sisters get Concussion Diagnostic funded, FDA approved and reimbursed

CEO Rosina Samadani is featured in a story by Geri Stengel at Forbes. Click here to read the full

Two sisters teamed up to develop and bring to market an EyeBOX—the first
objective diagnostic for concussions. The algorithm-based test takes less than four
minutes, is non-invasive, and can be used with children and adults. Oculogica’s
EyeBOX moves beyond the subjective “follow my finger” to an objective technology
that diagnoses concussions accurately.
Experience, relationships, diplomacy, and perseverance helped the pair jump over
the typical hurdles of funding, FDA clearance, and payer reimbursement that a
medical device must navigate to be a success.

he first version of the product was brought to market in 2019 and a portable, user-
friendly device launched in March of 2022. “We just installed it at the Mayo Clinic,
which is a very big deal,” said Rosina. “It’s considered the number one clinic in the
country, and we’re extremely excited about that.”
Other institutions, such as Midwest Orthopaedics at Rush, a top-10 orthopedic
hospital in the country, Children’s Hospital of Philadelphia, the University of
Colorado, and the Minneapolis Clinic of Neurology are using the device, too.
Oculogica will be launching a product for a second indication to measure impairment
due to cannabis. Since the product is intended for use by law enforcement and not
medical providers, it does not need to go through FDA clearance and get CPT

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