VUNO, a South Korean medical artificial intelligence company, has received 510(k) clearance from the United States Food and Drug Administration for VUNO Med-DeepBrain, software that automates the measurement of brain structures from an MRI scan. The company says the product is its first FDA clearance.

VUNO says the software identifies and quantifies more than 100 brain regions, provides cortical thickness and white matter hyperintensity measurements, and compares a patient's atrophy against a normal population, producing a report a clinician can adjust. It has potential use in dementia and other neurodegenerative conditions, the company says, and was the subject of research presented at the Alzheimer's Association international conference in July 2023.

Why measurement is the hard part

Reading a brain scan is repetitive, and doing it consistently is harder than it sounds: two radiologists can measure the same region differently, which makes it difficult to track change over years. A tool that produces the same number twice is therefore useful in a way a consumer health gadget is not, because it addresses a measurement problem rather than a diagnosis problem.

That is also its limit. Clearance means the software may be marketed; it does not mean clinicians are paid for using it, or that measuring a brain more precisely changes what happens to a patient. Those are matters of reimbursement and of clinical evidence, and the release claims neither.

The company's chief executive, Yeha Lee, said the clearance was a steppingstone to the United States market and pointed to the declining quality of life of many dementia patients. Whether a tool that quantifies scans actually reaches them depends on hospital budgets rather than on the regulator, and it is early to say how far it travels.