Satisfai Health receives FDA Breakthrough Device Designation for analysis of Barrett's Esophagus and Early Esophageal Cancer with its Artificial Intelligence tool, "Veritai", during endoscopy
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Advanced real-time clinical diagnostics at the point of care to help detect early and treatable cancer in millions of people around the globe.
Vancouver, British Columbia, Canada – TheNewswire - 18 December 2023 - Satisfai Health Inc., a Canada-based leading medical solutions provider specializing in artificial intelligence (AI) applications in Gastroenterology and GI Endoscopy, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its AI tool, “Veritai”, for the proposed indications for use to include real time computer-aided detection and characterization intended to aid in detection, delineation, and characterization of neoplastic (cancerous) Barrett’s Esophagus (BE).
The FDA Breakthrough Device Designation expedites the review of innovative technologies that can improve the lives of patients with life-threatening or irreversibly debilitating diseases or conditions for which no approved or cleared alternatives exist. To qualify for a Breakthrough Device Designation, a device technology must address an unmet need and show that it has the potential to provide for more effective treatment of life-threatening diseases or irreversibly debilitating conditions.
Barrett's Esophagus is a gastrointestinal condition affecting around 150 million people globally, and is most commonly associated with long-standing reflux or heartburn. Approximately 1 in 200 patients with Barrett’s will develop cancer each year. The current practice in endoscopic surveillance of Barrett’s is to take multiple biopsies throughout the length of disease involvement, but this practice still results in many missed early cancers. Veritai has been trained to find dysplasia/early cancer within the entire BE segment in the esophagus.
“Being granted a breakthrough designation by the FDA is a great validation of the potential of our Veritai solution in the management of patients with Barrett’s Esophagus. Finding pre-cancerous or early cancerous change in the esophagus allows for potentially curative therapies to be employed, often in a non-invasive manner with endoscopic treatment”, said Dr. Michael Byrne, Satisfai Health CEO and founder, Gastroenterologist, and Clinical Professor of Medicine in Vancouver. “Too many patients are diagnosed with esophageal cancer at a late stage. We are extremely excited that Veritai might transform the current landscape with improved patient outcomes and reduced healthcare costs.”
With this Breakthrough Device designation, Satisfai benefits from an accelerated pathway for the assessment and review of Veritai by the FDA. This will help with getting Veritai into multi-centre trials as soon as possible and productizing it for clinical use.
AI software that will transform the management of Barrett's Esophagus and Early Esophageal Cancer
"We need solutions to improve early cancer detection in Barrett’s Esophagus, and I am delighted that we have received this breakthrough designation from the FDA”, said Dr. Helmut Messmann, Professor of Gastroenterology at the University of Augsburg, Past President of the European Society of Gastrointestinal Endoscopy (ESGE), and advisor to Satisfai.”
“As a scientist, I am delighted to see us moving closer to having our Veritai tool adopted into clinical practice. The sooner we have improved solutions available for patients, the better”, stated Dr. Christoph Palm, Professor of Medical Image Computing and AI at the Technical University of Applied Sciences Regensburg (OTH Regensburg).
Dr. James East, Associate Professor in Gastroenterology at John Radcliffe Hospital, University of Oxford, and advisor to Satisfai, added, "This welcome news from the FDA brings us closer to having a Barrett's AI expert at our shoulder in every endoscopy room."
The device is not intended to drive clinical decision making or to replace clinical judgement.
Satisfai Health is a leading medical solutions provider specializing in AI applications for gastroenterology. The company is on a mission to create the most comprehensive range of AI solutions for gastrointestinal practice and research to enhance the quality, reach, speed, and affordability of existing methods for detection, diagnosis, and treatment assessment in the field of gastroenterology.
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