Free Design Audit Available - Click Here for Details

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.

Sign up for Blog Updates