Deep Capsule® (Deep Capsule US)

“Deep Capsule® is an artificial intelligence (AI) assisted reading tool designed to aid small bowel capsule endoscopy reviewers in decreasing the time to review capsule endoscopy images for adult patients in whom the capsule endoscopy images were obtained for suspected small bowel bleeding.”

“The Deep Capsule detection algorithm is based on convolutional neural networks using different deep learning models.”

“Regarding the cybersecurity, documentation included recommended information from the FDA guidance document "FDA Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" This includes threat identification, vulnerability assessment, likelihood and impact assessment, cybersecurity mitigation information, security policies and controls, continuous monitoring and review activities, regular auditing and cybersecurity testing.”