US-based manufacturing company AnX Robotica has received FDA de novo clearance for its AI-assisted endoscopy tool, NaviCam ProScan. The tool utilizes a deep learning algorithm called convolutional neural networks (CNNs) to identify and differentiate healthy tissue and abnormal lesions in small bowel capsule endoscopy (SB-CE) images. AnX Robotica conducted a study with over 133 million images from 6,970 patients, showing that the CNN-based auxiliary model identified abnormalities with 99.88% sensitivity, compared to 74.57% in conventional readings by gastroenterologists. This innovative tool is seen as a significant advancement, particularly for patients suspected of gastrointestinal bleeding.
The global revenue for AI platforms is expected to reach $908.7 billion by 2030, with medical imaging playing a crucial role in driving AI growth in healthcare. Other companies, such as Cosmo Intelligent Medical Devices, Medtronic, NVIDIA, L&T Technology Services Limited (LTTS), AstraZeneca, and IKN, have also ventured into AI-assisted medical devices and technologies. The FDA-approved GI Genius, an AI-assisted colonoscopy device for colon cancer screening, was developed by Cosmo Intelligent Medical Devices in 2021, and various collaborations and acquisitions in the field of AI and endoscopy have been observed in recent months, reflecting the industry’s growing interest in leveraging artificial intelligence for medical diagnostics.