RadNet Gets FDA Clearance for Mammography and Prostate AI Tools

RadNet has received FDA 510(k) clearances for its DeepHealth Saige-DX mammography and Quantib Prostate 2.0 magnetic resonance imaging (MRI) software.

Saige-DX is a more advanced successor to the FDA-approved Saige-Q worklist triage software, according to the company, which has offices in Cambridge, Mass., Rotterdam, Netherlands, and Los Angeles, Calif.

The artificial intelligence software helps radiologists detect the presence or absence of breast cancer. It automatically identifies suspicious lesions in mammograms and assigns a suspicion level to each finding, which helps detect and diagnose breast cancer earlier while reducing recalls for additional testing.

Quantib Prostate, which is intended to improve the prostate MRI analysis, includes tools to improve the reporting quality and speed.