Imvaria and Darmiyan receive FDA authorizations for AI-enabled diagnostic tools

The de novo classifications cover software for detecting a lung condition and assessing dementia risk.

The Food and Drug Administration has granted de novo authorization to artificial intelligence (AI) diagnostic tools from Imvaria and Darmiyan.
Imvaria received authorization for a tool that analyzes CT scans to identify patterns that indicate a patient may have idiopathic pulmonary fibrosis (IPF). Researchers have generated evidence the system could reduce the number of lung biopsies.
Darmiyan’s authorization covers Brainsee, software that uses an MRI scan of a patient’s brain and their scores on cognitive tests to determine the likelihood of progression from mild cognitive impairment (MCI) to Alzheimer’s dementia within five years.

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