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Completed manufacturing registration for medical device program
Araya 's neuroscience, AI analysis technology, and software development technology enable it to support social implementation of healthcare-related seeds.
Ltd. ( Araya) registered as a medical device manufacturer (registration number: 13BZ201806) on December 12, 2023, for the purpose of expanding its business into the medical field by utilizing its brain imaging analysis and software development capabilities that it has been performing since its establishment. This allows Arayato design medical device programs ( *1) in Japan.
In recent years, the digital healthcare market has been growing rapidly, especially in Europe and the United States, due to developments such as AI. In line with the growth of the market overseas, the number of programmed medical devices (SaMD) (*2) that require regulatory approval in Japan is on an increasing trend. (*3 ) In light of this social background, Arayahas registered as a manufacturing business for programmed medical device design with the aim of supporting the implementation of research seeds that lie both inside and outside the company. We hope to help promote product development and social implementation of the seeds of research and development at universities and research institutes, as well as DTx and SaMD development at pharmaceutical and healthcare companies.
ARAYACAN ASSIST IN ALGORITHM DEVELOPMENT AND DATA ACQUISITION PLANNING BASED ON OUR EXPERTISE IN NEUROSCIENCE AND STRONG ANALYSIS TECHNIQUES, SUCH AS IMAGE RECOGNITION AI, BRAIN IMAGE X AI, ETC. FOR EXAMPLE, WE CAN ASSIST IN ALGORITHM/SOFTWARE DEVELOPMENT FOR USE IN DISEASE-RELATED IMAGE DIAGNOSIS/DIFFERENTIATION/ESTIMATION PROGRAMS THAT MAY BE APPLICABLE TO MEDICAL DEVICE PROGRAMS.
ArayaSince its inception, the company has had a number of cognitive neuroscientists (M.D., Ph.D., Ph.D.) on its staff who have conducted various research and algorithm development projects utilizing brain imaging. In addition to our own research, we also provide research and development support to medical research institutes, and we have 19 projects under our belt. （Our in-house researchers provide advice on clinical trials for the purpose of acquiring data for the development of your medical device programs, and develop algorithms utilizing AI and other technologies. Please contact us for our expertise and development of medical device programs, etc. in anticipation of implementation.
Contact us: Contact form https://www.araya.org/contact/
*1: Medical device program
A program (software function) that has a purpose as a medical device and that may affect the life and health of the patient (or user) if it does not function as intended.
(Reference) Ministry of Health, Labour and Welfare What is a medical device program?
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000179749_00004.html
*2: Programmed medical devices (SaMD)
A device that is intended to be used for diagnosis, treatment, or prevention of human diseases or to affect the structure or function of the human body in a tangible form installed in a general-purpose computer, portable information terminal, etc.
March 13, 2023 Draft Plan for FY2023 [Supplementary Materials], Pharmaceuticals and Medical Devices Agency, p. 19.
https://www.pmda.go.jp/files/000251385.pdf
*3: Number of approvals of programmed medical devices by fiscal year
March 13, 2023 Draft FY Plan [Supplementary Materials], Pharmaceuticals and Medical Devices Agency, p19.
https://www.pmda.go.jp/files/000251385.pdf
Company Profile
Company name: Kabushiki Kaisha, Ltd. Araya
Representative: CEORyota Kanai
Established: December 2013
Location: 6F Sanpo Sakuma Building, 1-11 Kandasakumacho, Chiyoda-ku, Tokyo
URL: https://www.araya.org/
Business: Deep Learning, Edge AI, Autonomous AI, Neurotech, Contract Research
For inquiries regarding this press release, please contact
Ltd. ArayaPublic Relations: Asai, Michibayashi
Home Page :https://www.araya.org/
e-mail: support@araya.org