All industry news
RegulationAugust 3, 2026

FDA grants 510K clearance for DeepHealth’s AI breast ultrasound technology

DeepHealth received FDA 510(k) clearance for DeepHealth Breast Ultrasound, an AI-based tool designed to assist in breast ultrasound imaging analysis. The clearance enables the company to market the software as a medical device in the US.

The source

This brief is a MedIndexer summary of reporting by Medical Device Network. To read the full story, head to the source.

Read the full story at Medical Device Network
MedIndexer aggregates and summarises publicly available headlines. Full article text remains the property of the originating publication.