AI Medical Service, a Tokyo-based startup, recently announced that the U.S. Food and Drug Administration has given its machine learning algorithm breakthrough device designation for its ability to analyze endoscopy images for potential diagnosis of gastric cancer.

According to the FDA, the Breakthrough Devices Program is a voluntary program “for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.”

The program’s goal is to provide patients and healthcare providers with timely access to these medical devices by speeding up their development, assessment, and review. From the program’s launch in April 2015 through the end of 2018, FDA granted 112 Breakthrough Device Designations to novel products that receive expedited and priority review for speeding up their approvals process. 

According to the company, neural network algorithms are trained on large real-world datasets of images of biopsy-proven cancer lesions, benign lesions, and normal tissue that were captured using standard endoscopes. The goal is to help doctors performing endoscopies easily detect lesions suspicious of cancer.

AI Medical says its “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.”

According to Dr. Tomohiro Tada, CEO of AI Medical Services, most companies training AI algorithms focus on colorectal cancer, whereas AI Medical has focused on gastric cancer.

“Most of our competitors developing endoscopy AI have started with colorectal cancer (probably because it is easier than gastric cancer to detect.) On the other hand, we have started with gastric cancer, which is said to be more difficult compared to colorectal cancer, and are developing an AI that can cover stomach, colon, esophagus and so on — ultimately the whole digestive tract,” Tada wrote in an email to news outlets.

In a glimpse at some of the challenges facing start-up technology firms, Tada added that winning this Breakthrough Device Designation is especially key for a Japanese company that doesn’t enjoy the benefits of the U.S. entrepreneurial ecosystem.

“To invent a revolutionary medical device/drug has become too expensive for a small company and too high-risk for an established company.  That is why in the US, you have [an] ecosystem [where] VCs provide [the] financial support for many seed-[stage companies and] eventually a few of [them] would be sold to large medical companies,” Tada said. “But we do not have such a system in Japan.”

AI Medical Service, Inc. collaborates with approximately 80 medical institutions representing Japan in the field of gastrointestinal endoscopy to research and develop AI endoscopies.