Lunit INSIGHT CXT Triage Gets FDA OK
Lunit has received US Food and Drug Administration (FDA) 510(k) clearance for its AI-powered chest x-ray triaging solution, Lunit INSIGHT CXR Triage, clearing the way for commercial availability in the US. The company will highlight the product at RSNA 2021.
Lunit INSIGHT CXR Triage is a computer-assisted triage and notiﬁcation software that analyzes chest x-ray images for the presence of pre-speciﬁed suspected critical ﬁndings. According to the company, the product is designed to triage and prioritize emergent cases such as pleural effusion and pneumothorax immediately after the exam, to have the ﬁndings notiﬁed to the physicians, thereby reducing the time-to-diagnosis of urgent cases.
"It's with great pleasure that we announce the ﬁrst FDA clearance of our chest x-ray AI solution," said Brandon Suh, CEO of Lunit. "Lunit INSIGHT CXR Triage can especially show its value in emergency settings where timely workﬂow is critical, and we look forward to installations in hospitals and medical centers across the United States."
The product is trained with over 160,000 chest radiographs with CT images and shows excellent performance of 94~96% sensitivity and 95~99% speciﬁcity on pleural effusion and pneumothorax. (ROC AUC=0.9864 and 0.9973 respectively). The high accuracy with instant prioritization of the patient x-rays can optimize workﬂow and help medical professionals provide timely treatment.
As Lunit INSIGHT CXR Triage is best applied with mobile-based x-ray devices that are often used in urgent care settings, the company can maximize current partnerships with global medical device companies such as Philips and FujiFilm.