NeuroLogica, the healthcare subsidiary of Samsung Electronics, has obtained the US Food and Drug Administration (FDA) approval for its Auto Lung Nodule Detection (ALND) tool.

ALND offers an on-device, computer-assisted detection (CADe) solution for detecting pulmonary nodules sized 10 to 30mm, using an artificial intelligence (AI) algorithm.

The tool is part of S-Station, an operation software installed on Samsung Digital X-ray Imaging systems, and is designed to help physicians in reviewing PA chest radiographs.

ALND assists the reader’s diagnosis by indicating the location of suspected lung nodules on posteroanterior chest radiographs (chest X-ray images).

It also provides an option to automatically perform nodule detection immediately after chest X-ray imaging, along with PACS transmission options to simplify the user workflow.

Samsung NeuroLogica digital radiography and ultrasound vice president David Legg said: “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.

“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.”

NeuroLogica said that the deep-learning technology used in ALND has been clinically verified at different university hospitals and was approved with more than 80% sensitivity.

The hospitals include Freiburg University Hospital in Germany, Massachusetts General Hospital, in the US, and Samsung Medical Centre in South Korea.

Investigators at the university hospitals have retrospectively identified 600 chest radiographs with lung cancer and 200 normal chest radiographs.

Results from the clinical evaluation showed that all the readers’ nodule detection performances using ALND have increased with statistical significance.

NeuroLogica is engaged in developing, manufacturing, and marketing advanced imaging technologies and accurate diagnostic solutions to healthcare providers.

The company is teaming up with Vuno, a developer of AI solutions in healthcare, to expand the use of chest CADe solution and improve diagnostic accuracy and workflow.