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Devices Gastroenterology FDA

 News Release - November 11, 2019

AI Medical Service Inc. announces FDA Breakthrough Device Designation for endoscopic AI system

TOKYO, Nov. 11, 2019 -- (Healthcare Sales & Marketing Network) -- AI Medical Service Inc., one of the world's first real-time endoscopic artificial intelligence (AI) developers, today announced the Company has secured Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its AI programs that analyze endoscopy images for potential diagnosis of gastric cancer. This designation will be critical as the Company continues to accelerate clinical and regulatory program especially in terms of prioritized review of the submission. At the same time as obtaining approval in its original country, Japan, the Company will continue to work through the regulatory process in the United States and other countries, and move on to global expansion.

Breakthrough Device Designation is granted to medical devices and device-led combination products that provide the potential for a more effective treatment option for life-threatening or irreversibly debilitating diseases. It expedites the traditional development, assessment and review process, and enables medical professionals to get access to new developments quickly.

AI Medical Service's system applies neural network algorithms which are trained with large real-world datasets of images of biopsy-proven cancer lesions, benign lesions, and normal tissue that were captured using standard endoscopes, thus aiding physicians performing endoscopies to detect lesions suspicious for cancer. AI Medical's technology is further differentiated as it is able to detect gastric, colorectal, and esophageal cancer, especially for concurrent usage whereas other entities' technology tends to focus only on colorectal cancer.

Dr. Tomohiro Tada, CEO of AI Medical Services, says, "We will launch this groundbreaking technology approved by the FDA as soon as possible in the US market. As our founding philosophy states, we plan to contribute to endoscopic medical treatment around the world."

About AI Medical Service, Inc.

AI Medical Service, Inc. collaborates with approximately 80 medical institutions representing Japan in the field of gastrointestinal endoscopy to research and develop AI endoscopies. The results have been widely accepted by experts all over the world, including the conference for Digestive Disease Week (DDW), the world's largest gastroenterology association, in which as many as 12 studies by AI Medical Service were selected for presentation including the one awarded as "Best of DDW." The company will enable the practical use of these technologies at an early stage and will contribute to the world's endoscopic medical practice by supporting physicians' diagnoses, thereby reducing the risk of overlooking diseases to the highest extent possible. To learn more, please visit, https://ai-ms.com/en

Additional information about Breakthrough Device Designation

There is a similar system for drugs (Breakthrough Therapy Designation), but the number of systems specified for medical devices is small (according to the FDA announcement, only 112 cases in the four years from 2015 to 2018) and it is extremely rare for a Japanese company to receive a designation.

https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-jeff-shuren-md-director-center-devices-and-1


Source: AI Medical Service

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