1 day Ago By Jung So-yeon
Coreline Soft has announced on April 18 that it has signed a supply agreement with the Japanese clinical research organization (CRO) Micron for its artificial intelligence (AI)-based imaging analysis software, AVIEW COPD. Founded in 2005, Micron is the largest imaging CRO in Japan and a subsidiary of CE Holdings, a medical AI company listed on the Tokyo Stock Exchange. Micron maximizes local regulatory compliance and clinical operation capabilities by providing regulatory services, including strategies for submissions to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, as well as supporting the clinical trial process.
Micron boasts over 700 references with local healthcare institutions and has a history of developing approximately 100 medical AI solutions. The company believes that collaboration with Micron, backed by extensive clinical experience, will allow it to meet Japan's stringent regulatory and high-quality standards. Following its existing key markets in the United States and Europe, Coreline Soft is diversifying into the Asian market, which is experiencing rapid growth in medical AI.
The company is currently expanding its presence in Japan through a partnership with domestic medical AI firm Vuno and has recently established a partnership with its Chinese affiliate, Suhai, to strengthen its entry into the world's largest market. AVIEW COPD is characterized by its unique AI technology, which maximizes early diagnostic capabilities for Chronic Obstructive Pulmonary Disease (COPD) while automating the entire analysis process. Coreline Soft has acquired multiple global certifications for AVIEW COPD, including those from the U.
S. Food and Drug Administration (FDA), CE markings in Europe, and PMDA approval in Japan, and it is supplying the software to major hospitals in the UK, Japan, Taiwan, and other countries. “The contract with Micron represents a comprehensive partnership that goes beyond mere product supply to include responses to regulatory agencies and the establishment of approval strategies in Japan," said Kim Jin-guk, CEO of Coreline Soft.
"Based on our collaboration with Micron, we will advance our PMDA approval strategy and clinical design while accelerating our market entry into Japan.” “Building on the trust we’ve established in the U.S.
and European markets, we are actively pursuing our Asian strategy, and this entry into Japan will serve as a foundation for sustainable business growth,” he added..
