RadNet’s DeepHealth expands FDA clearance for SmartMammo solution

DeepHealth, a wholly-owned subsidiary of RadNet (RDNT), has received expanded FDA 510(k) clearance for its mammography software. SmartMammo Dx, the AI algorithm within SmartMammo, is now FDA-cleared to be compatible with GE HealthCare’s (GEHC) Senographe Pristina mammography systems. SmartMammo Dx was first cleared in May 2021 in conjunction with Hologic mammography systems, where its performance has also been tested and cleared in patients with unilateral breasts and with breast implants. “This newly expanded clearance advances DeepHealth’s mission to enhance and expand breast cancer screening programs by broadening system compatibility,” the company stated.