RadNet subsidiary DeepHealth has received 510(k) clearance from the US Food and Drug Administration (FDA) for DeepHealth Breast Ultrasound, an AI-based tool developed for breast ultrasound imaging.
The technology is available for sale in the US, enabling healthcare providers to access reimbursement through an existing Category III CPT code for quantitative ultrasound tissue characterisation.
The DeepHealth Breast Ultrasound system automates the detection, characterisation, and reporting of breast lesions.