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Japanese AI Algorithm for Gastric Cancer Awarded Breakthrough Device Designation by the FDA


In early November, Japanese startup AI Medical Service received the FDA’s Breakthrough Medical Device designation for an artificial intelligence (AI) algorithm that analyzes images from endoscopies for the potential diagnosis of gastric cancer. Since the program began in April 2015 until the end of 2018, the FDA has granted a total of 112 Breakthrough Device Designations. These original products earn accelerated and preferred review; this quickens the process of their approval. 

The goal of AI Medical Service’s AI is to assist physicians who perform endoscopies in easily locating lesions that could point to cancer. The company does this by making use of neural network algorithms that have been trained on expansive datasets of images of biopsies proven to be benign lesions, cancerous lesions, as well as normal tissue that were taken during standard endoscopy procedures.

AI Medical took to a press release to discuss what sets them apart. They stated that their “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.”

CEO Tomohiro Tada wrote in an email forwarded to MedCity News that “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.”

AI Medical also apparently feels that winning the Breakthrough Device Designation from the FDA is a big deal for a Japanese company, because they don’t benefit from the economic landscape here in the United States that often uplifts entrepreneurs. “To invent a revolutionary medical device/drug has become too expensive for a small company and too high-risk for an established company [in Japan],” Tada said.  

While it remains to be seen how far AI Medical Service will go in Japan and beyond, receiving the FDA’s Breakthrough Medical Device award is a promising start.