The tool is designed for use in the real-time analysis of Barrett’s Esophagus (BE) and early esophageal cancer during endoscopy procedures. Barrett’s Esophagus, a condition linked to long-term reflux or heartburn, affects approximately 150 million people globally, with a risk of developing cancer each year. The current method of endoscopic surveillance involves multiple biopsies, but this often results in missed early cancers. Veritai aims to improve this by detecting dysplasia or early cancer within the entire BE segment in the esophagus.
The FDA’s Breakthrough Device Designation is granted to innovative technologies that can significantly improve patient outcomes for life-threatening or irreversibly debilitating diseases, especially when no approved or cleared alternatives exist. This designation will expedite the review process for Veritai, facilitating its entry into multi-center trials and clinical use.
Dr. Michael Byrne, CEO and founder of Satisfai Health, emphasizes the potential of Veritai in managing patients with Barrett’s Esophagus, allowing for potentially curative, non-invasive treatments. The tool is expected to transform patient outcomes and reduce healthcare costs. Other experts, including Dr. Helmut Messmann, Dr. Christoph Palm, and Dr. James East, also express their enthusiasm for the tool’s potential in improving early cancer detection in Barrett’s Esophagus.
Satisfai Health, a leader in AI applications for gastroenterology, aims to enhance the quality, reach, speed, and affordability of detection, diagnosis, and treatment assessment in gastroenterology through comprehensive AI solutions. The article concludes with contact information for Satisfai Health.