DeepHealth

Deals & regulation

1. Jul 30

   Cleared by U.S. Food and Drug Administration

2. Jun 25

   Cleared by U.S. Food and Drug Administration

Trends

• FDA authorizations extend clinical AI into new specialties and LLMs

Items

1. Jul 30

   FDA clears DeepHealth breast ultrasound AI

   The 510(k)-cleared software automates breast-ultrasound lesion detection, characterization, and reporting and will be deployed across RadNet's network, which handles an estimated 700,000+ breast-ultrasound studies a year.

2. Jun 25

   FDA clears two DeepHealth breast-imaging tools

   RadNet's DeepHealth won 510(k) clearances for automated Breast Arterial Calcification assessment, which surfaces cardiovascular risk from routine screening mammograms, and prior-exam comparison for its ProFound cancer-detection app.