Friday, October 29, 2021
NeuroLogica Corp. today announced it has received Food and Drug Administration (FDA) 510(k) clearance for its Auto Lung Nodule Detection (ALND) tool. The offering provides an on-device, computer-assisted detection (CADe) solution for detecting pulmonary nodules from 10 to 30mm in size through an artificial intelligence (AI) algorithm.*
It is designed to aid the physician in reviewing PA chest radiographs of adults and is part of S-Station, an operation software installed on Samsung Digital X-ray Imaging systems.
“This FDA clearance is a huge milestone for Samsung and is the result of our tireless work to design diagnostic solutions that empower providers to deliver patients the absolute best care possible,” said David Legg, Vice President of Digital Radiography and Ultrasound at Samsung NeuroLogica. “The fact that it delivers clinically reliable results means clinicians can present it to patients with the utmost confidence, and for that we’re very proud.”
Benefits of ALND include:
Clinical evaluation results have demonstrated that all readers' nodule detection performances using ALND have increased with statistical significance.
As part of our commitment to advancing diagnostic radiology using AI, Samsung is collaborating with Vuno, a leading developer of AI solutions in healthcare. As part of our collaboration, we will expand the uses of the chest CADe solution and improve the diagnostic accuracy and workflow.