Nov 15, 2021 — 3 min read
First FDA 510(k) clearance from its AI software product lineup for radiology, specialized in triaging emergent cases found in chest x-ray
Company to accelerate business in the US market, leveraging partnerships with GE Healthcare, Philips, FujiFilm
Product to be introduced during RSNA 2021 booth #4545
Lunit, a leading medical AI provider, today announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its AI-powered chest x-ray triaging solution, ‘Lunit INSIGHT CXR Triage’. With this first FDA clearance, the company is now able to commercially provide the AI solution to medical professional and healthcare institutions in the U.S.
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.
Demo image of Lunit INSIGHT CXR Triage
“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.
The FDA clearance can also boost the company’s plan to accelerate its sales expansion in the US market. 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 like GE Healthcare, Philips, and Fujifilm.
Lunit INSIGHT CXR Triage will be presented at RSNA 2021, scheduled to be held on 28 Nov - 2 Dec 2021, at Chicago. Lunit booth will be located in AI Showcase, booth #4545.
Lunit to unveil data-driven imaging biomarker at RSNA 2016
Lunit INSIGHT: The First-ever, Real-time Imaging AI Analytics on the Web
Cognitive biases and augmented intelligence in radiology
Uncertainty and Deep Learning
Lunit Returns to RSNA with Real-time Imaging Platform, Featuring Cloud-based A
Lunit Unveils “Lunit INSIGHT,” A New Real-time Imaging AI Platform on the Web at RSNA 2017
Lunit INSIGHT: Q&A with Brandon B. Suh, Chief Medical Officer at Lunit
Lunit Opens “Lunit INSIGHT for Mammography” for Public Access
Lunit Brings its Newest AI Solution for Mammography to RSNA 2018
Lunit Partners with Fujifilm and Salud Digna to Provide Medical AI Solution in Mexico
Lunit announces new members in its advisory board: Dr. Eliot Siegel, Dr. Linda Moy, and Dr. Khan Siddiqui
Lunit to Showcase AI Solution for Breast Cancer at SBI 2019
Lunit Receives Korea MFDS Approval for its AI Solution for Breast Cancer, Lunit INSIGHT MMG
Lunit Gets Korea MFDS Approval for its AI Solution for Chest X-ray, Lunit INSIGHT CXR 2
Lunit at RSNA 2019
Lunit Announces its First CE Mark for AI-Powered Chest X-ray Analysis Software, Lunit INSIGHT CXR
Lunit AI software clinically installed in global sites—to be presented at RSNA 2019
AI-assisted Radiologists Can Detect More Breast Cancer with Reduced False-positive Recall
Lunit Releases Its AI Online to Support Healthcare Professionals Manage COVID-19
Lunit INSIGHT MMG, an AI Solution for Breast Cancer Detection, Now CE Certified
AI Solution for COVID-19, Developed by Medical AI Firm Lunit, Now Has Users in More Than 10 Countries
Lunit at ECR 2020: Providing Virtual Exhibition and Online Presentations
Emergent Connect Partners with Lunit to Provide Cloud Based AI Solutions
AI Analysis Can Improve Lung Cancer Detection on Chest Radiographs
AI has Added Value in Insurance Underwriting Process, Recent Pilot Project Between Lunit and Cathay Financial Innovation Lab Reveals
RSNA 2020--Lunit Collaborates with Global Giants in Presenting its AI Solution at Virtual Booths of GE Healthcare, FujiFilm, and Sectra
AI Proves Its Value in Assistance for Emergency Cases-- With Higher Accuracy and Timely Reporting Time of Chest Radiographs
Lunit Expands Collaboration with GE Healthcare to Advance AI Adoption across Healthcare Industry
AI Can Offer Fast and Reliable Examination to Triage COVID-19 Patients-- A Multicenter Retrospective Study Reveals
Recent Studies Reveal High Performance of Lunit AI in Breast Cancer Detection
South Korean Medical AI Provider and PACS Leader Enters Indonesian Market, to Help COVID-19 Screening and Diagnosis
What do medical studies say about AI for COVID-19 management?
What do the medical journals say about AI-powered mammography?
Research Using Lunit Demo Website
Lunit Presents AI-powered Pathologic Classification of Immune Phenotype that Predicts Response to Immunotherapy at USCAP 2021
What do the medical journals say about AI-powered chest x-ray interpretation?
Join our webinar with Dr. Fredrik Strand
From retrospective to prospective trials of AI in breast cancer screening
AACR 2021 - Lunit Presents Abstracts Demonstrating the Potential of its AI Biomarker in Cancer Treatment
Will AI Identify Breast Cancer Better Than Radiologists in Actual Clinical Screening?
Case of the Month | Where Is Breast Cancer?
AI-based Analysis of Cancer Tissue Predicts Response to Immunotherapy--Findings to Be Presented at ASCO 2021
Clinical Application of Lunit AI For Chest Radiography and Mammography to Be Presented at AOCR 2021
Lunit Secures $26M Investment from Guardant Health in a Strategic Funding Round
A Multi-reader Study Finds Unnecessary CT Exams Can Be Reduced by 30% When Analyzing Chest Radiographs with AI
Fujifilm Introduces its AI-powered Product for Chest X-ray in Japan, in Collaboration with Lunit
Lunit Collaborates with Intel to Provide AI Solutions to CPU-Based Customers in Need of Effective X-ray Diagnosis
Lunit AI Applied to Clinical Trial for Drug Development for the First Time--Findings Presented at ESMO 2021
Case of the Month (Chest x-ray)
COVID Global User Testimonials
Where is Cancer?
Breast Cancer Awareness Month — Ambassador Messages
TimeSformer: Is Space-Time Attention All You Need for Video Understanding?
Evaluation curves for object detection algorithms in medical images
Lunit to Participate in RSNA 2021, Presenting its New AI Solutions for Digital Breast Tomosynthesis and Chest CT
RadLink, Singapore’s Leading Imaging Center, Adapts Lunit AI to Analyze Chest X-rays and Mammograms
Lunit Expands Team with Multiple Industry Leaders to Accelerate its Business Growth
Lunit Presents Studies at SITC 2021, Highlighting the Effectiveness of AI in Predicting Response to Immunotherapy in a Clinical Trial Setting
Lunit's AI Software for Breast Cancer Detection, Lunit INSIGHT MMG, Wins FDA Clearance
Research Backs Clinical Efficacy of Lunit's Radiology AI Products; Abstracts to be Presented at RSNA 2021
Medical AI Provider Lunit Raises $61M in Funding Round Led By Major Global Healthcare Investors
Lunit Named to the 2021 CB Insights Digital Health 150 -- List of Most Innovative Digital Health Startups
Lunit Obtains MDSAP Certificate, Granted Fast-Track Regulatory Process in Major Countries
Lunit to Showcase Chest and Breast Radiology AI in Arab Health 2022
Baheya Foundation, Egypt’s Premier Destination for Breast Cancer, Adopts Lunit AI to Enhance Early Screening
Lunit AI Demonstrates Accuracy in Practical Assessment of Cancer Tissue-Findings to Be Presented at USCAP 2022
Case of the Month (Chest x-ray) - Tuberculosis Case
Medical AI Startup Lunit gets Preliminary Approval to go Public on KOSDAQ
Lunit AI solution for PD-L1 expression analysis receives CE mark
Lunit AI Biomarker PD-L1 Demonstrates Clinical Efficacy as Diagnostic Aid in Cancer Treatment–Published in the European Journal of Cancer