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 year. The results showed improvement in readers’s performance in cancer detection in mammograms with pairs with the MammoScreen software.
“We believe MammoScreen will provide quick and reliable confirmation of Radiologists’ suspicions as they read,” said Matthieu Leclerc-Chalvet, Therapixel CEO. “This AI solution will ensure a more certain assessment by Radiologists and a speedier reassurance of women having breast cancer screening exams, resulting in a more efficient workflow and reduced costs for the healthcare system. We look forward to installing MammoScreen in radiology departments and institutions across the U.S. so imaging professionals and women can benefit from its use.”