AIDOT (CEO Jung Jae-hoon) announced on November 13, 2023 that it obtained Class 3 medical device product approval from the Ministry of Food and Drug Safety (MFDS) for its AI-assisted gastroscopy diagnostic software, “GIGA dot AI.”
GIGA dot AI is characterized as the only solution in Korea in which AI assists diagnosis across six severity classifications, and it is an AI-assisted diagnostic software that distinguishes and analyzes the following with high accuracy: advanced gastric cancer (AGC), early gastric cancer with submucosal invasion (EGC(SM)), early gastric cancer confined to the mucosa (EGC(M)), high-grade dysplasia (HGD), low-grade dysplasia (LGD), and normal (Normal). The company stated that it secured high performance with sensitivity of 88.7 or higher and specificity of 91.9 or higher.
It also stated that it secured a lesion-detection speed of up to 40 FPS during endoscopic procedures in which specialists detect lesions in real time, enabling lesions to be identified during the procedure without a time lag compared with the endoscopy screen.
In clinical settings, whether an endoscopic resection is possible is determined according to the depth of tumor cell invasion, and to predict the depth of invasion into the gastric wall, an endoscopic ultrasound examination is separately required.
However, a company official said that if the GIGA dot AI solution is used together with endoscopy equipment, it becomes possible to receive an assessment of the likelihood of severity for early gastric cancer with submucosal invasion using only the input endoscopic images, enabling faster and more accurate diagnosis.
Lim Yoon-jae, Head of Division at AIDOT, said that through a clinical study conducted this June together with Professor Bang Chang-seok’s team at Hallym University Chuncheon Sacred Heart Hospital, they secured safety and clinical effectiveness, and that ultimately, after MFDS review of the final clinical trial report and technical documentation, they obtained Class 3 medical device product approval.
He also said that the screening market for gastric cancer diagnosis is rapidly expanding globally, and that this approval created an opportunity to enter the global market quickly. He emphasized that GIGA dot AI is a product that uniquely secures fine-grained severity classification, fast lesion-detection speed, and a user-friendly interface that specialists find convenient to use, and stressed that the company will pioneer global markets with these differentiated functions.
Professor Bang Chang-seok of Hallym University Chuncheon Sacred Heart Hospital stated, “In addition to the six severity classifications, we have successfully concluded additional classification research for low-grade dysplasia (LGD), and we plan to pursue additional approvals following this approval,” adding that they will not spare continued efforts in research that helps medical staff make more accurate diagnoses with the assistance of AI.
Korea Economic TV / 2023.11.13 / Senior Reporter Yang Jae-joon
