Micron

Micron, Inc. is an Imaging Contract Research Organization (iCRO) founded in Kobe, Japan, in October 2005. The company provides comprehensive support for clinical trials that use medical imaging. As a CRO, Micron supports the development of pharmaceuticals and medical devices, as well as the registration, manufacturing, and sales of Software as a Medical Device (SaMD) products. Their services include clinical development support like monitoring and quality control, an imaging core lab, image analysis, central imaging review, and consulting for clinical development. They also offer support for PET tracer manufacturing and imaging biomarker development.

The company serves clients in the pharmaceutical and medical device industries, managing imaging for clinical trials globally, with a significant presence in the Asia Pacific region. Micron's imaging studies have been conducted in numerous countries, including the United Kingdom, Brazil, China, Singapore, Taiwan, and South Korea. The company's business model revolves around providing specialized iCRO services, conventional CRO services, and support for the entire lifecycle of medical devices, including SaMD. They also generate revenue from the distribution of image analysis software and have a second-class marketing license for medical devices in Japan.

Micron was established as a pioneer company in the field of molecular imaging. Over the years, it has expanded its operations, establishing offices in Tokyo, Osaka, and Nagoya. A significant milestone was receiving a second-class medical device marketing license in November 2017. The company has also expanded through strategic partnerships, such as a business partnership with Kreivo Health to bridge Asian and European healthcare markets, particularly for SaMD. As of December 2021, Micron had supported the approval of 8 out of 30 approved SaMD programs in Japan. The current President & CEO is Hiroaki Suzuki.

Keywords: imaging contract research organization, iCRO, clinical trials support, medical imaging analysis, pharmaceutical development, medical device development, SaMD, software as a medical device, clinical research, imaging biomarkers, PET tracer support, central imaging review, regulatory support, Asia Pacific clinical trials, Japanese medical device market, molecular imaging, clinical data management, healthcare technology, biopharmaceutical services, diagnostic imaging