US-based manufacturing company AnX Robotica has received de novo clearance from the US Food and Drug Administration (FDA) for its artificial intelligence (AI)-assisted endoscopy tool NaviCam ProScan.
NaviCam Proscan utilises a deep learning algorithm called convolutional neural networks (CNNs), which are designed to identify and differentiate healthy tissue and abnormal lesions in different images.
In 2019, AnX Robotica published a study in the Gastroenterology Journal, which observed over 133 million images from 6,970 patients who had SB-CE at 77 medical centres between July 2016 and July 2018.
In the validation set of SB-CE images, a total of 4,206 abnormalities were found in 3,280 patients. The CNN-based auxiliary model identified abnormalities with 99.88% sensitivity in per-patient analysis, compared to 74.57% in conventional readings by gastroenterologists. The CNN-based auxiliary reading also reduced the mean reading time per patient.
In the announcement accompanying the clearance, Gemelli Hospital endoscopy and digestive surgery director Dr Cristiano Spada said: “This groundbreaking AI-Assisted Reading Tool represents a pivotal advancement in small bowel capsule endoscopy, particularly for patients suspected of gastrointestinal bleeding.”
According to a report by GlobalData, the global revenue for AI platforms is forecasted to reach $908.7bn by 2030, with medical imaging predicted to be a major driver of the growth of AI in healthcare.
GlobalData is the parent company of Medical Device Network.
The first AI-assisted colonoscopy device for colon cancer screening GI Genius, developed by Cosmo Intelligent Medical Devices, gained clearance from the FDA in 2021. Several companies have been following suit in recent months, with medical device giant Medtronic joining forces with Cosmo last month to integrate AI into endoscopic modules.
In November 2023, NVIDIA entered a collaboration with L&T Technology Services Limited (LTTS) to develop software for endoscopy-oriented medical devices, while AstraZeneca and IKN partnered in September to launch AI X-ray technology for early lung screening at government clinics and hospitals across Malaysia.
In June 2023, Olympus acquired Odin Vision, a UK-based cloud-AI endoscopy start-up company, for $79m. Under the transaction, Olympus acquired commercially available computer-aided detection software and cloud-enabled applications.
