HACARUS Obtains Medical Device Manufacturing and Sales License 

HACARUS Obtains Medical Device Manufacturing And Sales License 

In an effort to bring much needed AI-enabled cancer diagnostics support to market HACARUS acquires Medical Device Manufacturing and Sales licenses

February 16th, 2022 – Kyoto, Japan – HACARUS INC, the leading provider of big insights from small data, today announced that it has successfully obtained the“Type 2 Medical Device Manufacturing and Sales Business License” and “Medical Device Manufacturing Registration Certificate” from Kyoto Prefecture on February 3, 2022.

The ongoing corona pandemic has put strain on an already burden healthcare system in Japan, where a lack human specialists to perform diagnosis means that demand for cancer screening is ever increasing – with these new licenses HACARUS takes another step to bring its novel AI solutions to assist in this crucial work.

“With corona cases increasing, and the number of cancer screenings simultaneously decreasing, it’s clear that a new approach is needed – at HACARUS we are committed to help scale specialist knowledge by building highly accurate diagnostic systems, and our mission is to contribute to society with our AI technology” said Kenshin Fujiwara, HACARUS’ CEO & Founder.

One out of every two people in Japan will experience some form of cancer. For early detection Magnetic Resonance Imaging (MRI) and internal cameras scans are key tools. However, a high level of expertise is essential for diagnosing the images and video data – as such a growing shortage of specialists able to perform analysis is an emergent bottleneck. HACARUS aims to relieve this by building highly accurate AI-based diagnosis support systems.

Evidence of the growing need was recently reported by the Japan Cancer Society, which found that the number of cancer screening examinees in the first half of 2021 (January to June) doubled compared to that of 2020 – but is still 17% less than the same period in 2019, well below pre-pandemic levels. Social distancing measures such as limiting the number of examinees per day and shifting from group examinations to individual examinations are among the factors for the decrease.

Obtaining the “Type 2 Medical Device Manufacturing and Sales Business License” and “Medical Device Manufacturing Registration Certificate” are the first steps in a process to ensure that HACARUS solutions can help assist in medical diagnosis. The firm is now preparing to file an application with the “Pharmaceuticals and Medical Devices Agency (PMDA)” for its software to be classified as a “medical device program” which will allow for its software to be approved for use in the medical field.


HACARUS INC. provides big insights from small data. Since its founding in 2014, the company has supplied solutions in 100+ AI projects across Medical and Manufacturing fields. Headquartered in Kyoto, Japan, and backed by Osaka Gas and Miyako Capital (Kyoto University), among others, HACARUS technology continues to enable humans to make better, faster, and more reliable decisions based on data-driven insight. HACARUS’ proprietary AI engine was built using Sparse Modeling, a method that understands data like a human would – by its unique key features and is far more resource, time, and energy-efficient when compared to Deep Learning. To learn more, visit https://hacarus.com



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