A neurosurgeon and brain injury researcher developed a concussion diagnostic device. Her sister, a biomedical engineer, an alum of McKinsey, MIT and four healthtech startups and has raised VC and brought healthtech to market. That’s teamwork family style.
submission means your clearance is based on an equivalent device, drug, or procedure that has been given clearance. As a result, yours should be approved, too.
Reimbursement is now Oculogica's hurdle."It's a bit of a catch-22, because one thing that is required is having CPT [Current Procedural Terminology] Category I code," said Rosina. To get a Category I code, you must get many claims."But you can't get a high volume of claims if you don't have coverage, and you can't get coverage if you don't have a Category I.
EyeBOX has received a CPT Category III code, a temporary code assigned to emerging technologies, services, and procedures. However, it needs a CPT Category I code before the EyeBOX procedure is automatically approved for payment by medical payers. Category I means the procedure or service is performed with a frequency consistent with the intended clinical use.
The 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."
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