NeuroLogica Corp., a subsidiary of Samsung Electronics, has received U.S. 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 30-millimeters in size through an artificial intelligence (AI) algorithm.*
Designed to aid the physician in reviewing posteroanterior chest radiographs of adults, the tool 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,” says 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.”
ALND helps aid the reader’s diagnosis by indicating the location of suspected lung nodules on chest x-ray images (posteroanterior chest radiographs). According to the company, the deep-learning technology has been clinically verified in multiple university hospitals and has been approved with a sensitivity of 80% or more. Investigators at these hospitals—Freiburg University Hospital, Freiburg, Germany; Massachusetts General Hospital, Boston; Samsung Medical Center, Seoul; and Severance Hospital, Seoul—retrospectively identified 600 chest radiographs with lung cancer and 200 normal chest radiographs, the company notes.