Therapixel today said it received FDA 510(k) clearance for its MammoScreen artificial intelligence-used software.
MammoScreen automatically detects and characterizes suspicious soft tissue lesions and calcifications in mammogram images while assessing malignancy. The results are then presented in a summary report that characterizes suspiciousness of lesions on a scale of 1 to 10, with one being least likely to be malignant and 10 being most likely.
“Receiving FDA clearance for MammoScreen is a major milestone for Therapixel,” founder and chief scientific officer Pierre Fillard said in a news release. “This is the result of our collaboration with radiologists over the last three years to turn the algorithm that won the DREAM challenge in 2017 into a powerful product that is truly meaningful to their day-to-day-work.”
The software received FDA clearance after submitting results from a multi-reader multi-case study conducted last yea…