The FDA has given 510(k) clearance to a new artificial intelligence system that aids in reading small bowel capsule endoscopy images.
The technology, called ProScan, is the first AI capsule endoscopy tool specifically for the small bowel, according to the company AnX Robotica.
The clearance follows accumulating research in AI-assisted endoscopy. Previous research using ProScan found that AI-assisted evaluation had a 99.88% sensitivity (95% CI, 99.67%-99.96%) for finding abnormalities in a per-patient analysis, compared with conventional reading by gastroenterologists, which resulted in a 74.57% sensitivity (95% CI, 73.05%-76.03%) (Gastroenterology 2019;157[4]:1044-1054.e5). The researchers also found that mean reading time decreased from 96.6±22.53 minutes by conventional reading to 5.9±2.23 minutes with the AI tool (P<0.001).
ProScan pairs with NaviCam, the company’s capsule endoscopy system, and is available for purchase in the United States.
—GEN Staff
Based on a company press release.
