AI Endoscopy Tech Receives FDA Breakthrough Device Designation

A month after raising $42.9 million in Series B funding to advance the research and development for artificial intelligence (AI) endoscopies, AI Medical Service today announced that the U.S. Food and Drug Administration (FDA) granted its system Breakthrough Device Designation.

The AI technology aims to improve endoscopic specialists’ diagnosis of gastrointestinal issues in the esophagus, stomach and intestines. The system uses algorithms which are trained with real-world data sets of images of biopsy-proven cancer lesions, benign lesions and normal tissue captured using standard endoscopes. This helps aid physicians who perform endoscopies to detect lesions which may be cancerous.

AI Medical Service’s technology helps detect gastric, colorectal and esophageal cancer, the company said.

The Breakthrough Device Designation by the FDA to medical devices and products that give way to a more effective treatment option for life-threatening or irreversibly debilitating diseases. The designation expedites the development, assessment and review process for the device, making it available for use more quickly.

The designation will help the Tokyo-based company continue to accelerate clinical and regulatory programs all while continuing to obtain regulatory approval in the U.S. and other countries globally.

“We are confident that AI Medical Service will provide breakthrough solutions for various medical institutes and endoscopy doctors that will greatly improve the standard of treatment across the global market,” said Gen Tsuchikawa, MBA, chief investment officer at Sony Innovation Fund by IGV, a participant in last month’s funding.

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