The approval enables the usage of the company’s AI programmes to analyse endoscopy images for potential diagnosis of gastric cancer
AI Medical Service has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its endoscopic artificial intelligence (AI) system.
The approval allows the use of the company’s AI programmes to analyse endoscopy images for potential diagnosis of gastric cancer.
AI Medical said that the designation helps the company to advance clinical and regulatory programme primarily in terms of prioritised review of the submission.
AI Medical’s technology can detect gastric, colorectal, and esophageal cancer
AI Medical’s system is said to apply neural network algorithms that are trained with large real-world datasets of images of biopsy-proven cancer lesions, benign lesions, and normal tissue, which were acquired using standard endoscopes.
The system will help physicians performing endoscopies in the detection of lesions suspicious for cancer.
Designed for concurrent usage, AI Medical’s technology holds capacity to detect gastric, colorectal, and esophageal cancer.
AI Medical Services CEO Dr Tomohiro Tada said: “We will launch this groundbreaking technology approved by the FDA as soon as possible in the US market. As our founding philosophy states, we plan to contribute to endoscopic medical treatment around the world.”
AI Medical Service works with around 80 medical institutions to research and develop AI endoscopies. The company will also help in the practical application of these technologies at an early stage.
In October this year, Fujifilm Medical Systems USA – Endoscopy, a division of Fujifilm Healthcare, announced plans to unveil eight new endoscopes for ERCP, EUS, Colonoscopy, and Gastroscopy, including ESD, EUS, and ERCP activities.
During the same month, Irish medical technology firm Medtronic has introduced the first AI system for colonoscopy.
The GI Genius intelligent endoscopy module is claimed to be the world’s first system that uses AI for the detection of colorectal polyps. Medtronic’s new AI system enables physicians to better treat colorectal cancer.
Medtronic has signed a worldwide distribution agreement with Cosmo Pharmaceuticals to commercialise the new AI system.