FDA clears See-Mode's AI-powered tool for automated breast ultrasound reporting

The FDA has granted 510(k) clearance to See-Mode Technologies for its SMART-B software, an augmented reporting tool designed to assist with breast ultrasound image analysis and report generation.

• The SMART-B tool is classified under product code QDQ, an ultrasound image management and reporting system.
• It is a software-only solution intended to augment, not replace, a clinician's review of breast ultrasound images.

Automated summary

RadPigeon summaries are original and for information only. They are not clinical advice.