FDA clears expanded use of RadNet subsidiary DeepHealth’s mammography AI solution
The U.S. Food and Drug Administration has cleared expanded use of RadNet Inc. subsidiary DeepHealth’s mammography AI solution, the two announced Nov. 29.
First OK’d by the FDA three years ago, SmartMammo Dx is now permitted for use with GE HealthCare’s Senographe Pristina mammography systems. The algorithm was first cleared for deployment on Hologic mammo systems in May 2021, with the product tested among patients with unilateral breasts and implants.
“This FDA clearance allows us to expand access to high-quality breast cancer screening to more patients,” Kees Wesdorp, president and CEO of RadNet’s Digital Health segment, said in an announcement. “
SmartMammo Dx is part of DeepHealth’s suite of breast health solutions aimed at aiding radiologists in interpreting DBT mammograms. It identifies soft tissue lesions and calcifications, assigning suspicion levels with increased accuracy. Based in Los Angeles, RadNet operates some 400 outpatient imaging centers, with the company acquiring DeepHealth for $44 million in 2020.
RadNet has issued a series of announcement tied to RSNA 2024, including partnering with CARPL.ai to develop a new “AI control system” that monitors and optimizes the performance of artificial intelligence solutions. DeepHealth also recently teamed with Siemens Healthineers to collaborate around improving ultrasound workflows and launched new AI-driven informatics solutions on Monday.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.