ExaWizards and SANKEN, Osaka University Jointly Operationalizes Program Medical Device (SaMD) for Major Neurocognitive Disorder Diagnosis Support
-Basic agreement reached on exclusive development and marketing of AI applications based on patents for medical evaluation-
ExaWizards Inc. (Headquarters: Minato-ku, Tokyo; Representative Director & President: Makoto Haruta; hereafter, “ExaWizards”) and SANKEN, Osaka University signed basic agreements for tthe exclusive development and future marketing of a medical device with an AI application to support dementia diagnosis. Both organizations will work together aiming to operationalize a medical device utilizing SANKEN’s relevant patents and ExaWizards’ unique AI technologies, and address the social issue of the early diagnosis/treatment of major neurocognitive disorder.
☑ Background to Joint Development
Medical devices implementing software such as AI application are called Program Medical Devices (SaMD: Software as Medical Device), and the U.S., Germany, and India are especially going ahead in the preparation for the development or practical use of AI-enabled SaMD. Compared with conventional medical devices, SaMD can be quickly developed at low cost, and mounted on wearable devices such as smartphones. SaMD is expected to be used not only in medical institutions but also for the progress of technologies for the prevention/early detection of diseases at home, or in daily lives. However, Japan currently lags behind other countries in the number of the application and approval of SaMD as a medical device due to the difficulty of development and its regulatory affairs different from those of overseas countries.
In this joint project, ExaWizards exclusively uses the decision-making model of major neurocognitive disorder that Professor Yasushi Yagi of SANKEN, Osaka University developed through his research at Japan Agency for Medical Research and Development (AMED). With an aim to apply for approval as a medical device, ExaWizards and SANKEN, Osaka University jointly develop an AI application. With the application approved, the device will be the first SaMD in the field of major neurocognitive disorder diagnosis.
☑ Roles of Both Parties
ExaWizards has been consistently developing businesses such as the strategy planning, development and implementation of AI-enabled services since the establishment. In the healthcare field, they have conducted a number of projects with pharmaceutical companies, universities/research institutions, medical institutions, IT companies, etc. They handle various data continuing to increase by fully utilizing the unique AI algorithms they have accumulated as well as their data platforms.
In this project, we will utilize such resources and knowledge to jointly work on implementing SANKEN’s patented technology as SaMD.ExaWizards has been granted an exclusive license to the patents held by SANKEN, and is also exclusively authorized to market SaMD using those patents.
SANKEN, Osaka University offers their knowledge and patent for the invention developed by Professor Yagi and others to this project aiming to implement the patent technology as SaMD. This patent is for the unique system named “Dual Task System” which makes possible the easy and accurate diagnosis of major neurocognitive disorder by simultaneously performing two and more tasks. SANKEN, Osaka University uses Dual Task System to simultaneously conduct a physical ability check and a cognitive test which are easy and take only a couple of minutes, and detects major neurocognitive disorder, Mild Cognitive Impairment (MCI), healthy people, and the signs of transition from MCI to major neurocognitive disorder.
☑ Overview of Patent
・Patent Number: 6407405
・Date of Registration: September 28, 2018
・Patentee: Osaka University
・Title of Invention: Evaluation Method for Dual Task Performing Ability and Evaluation System for Dual Task Performing Ability
It is reported that the number of major neurocognitive disorder patients exceeds 6 million in Japan, and the population of the elderly aged 75 or over who are said to have a high risk of having major neurocognitive disorder reaches as many as 20 million (according to a survey conducted by Ministry of Health, Labour and Welfare/ Cabinet Office). Once major neurocognitive disorder occurs, it is very hard to find an effective therapy, and caregivers such as the patient’s family members are also stressed out with a big burden. Under such circumstances, it is said that early detection and treatment are important. It is believed that the early diagnosis of major neurocognitive disorder is difficult even for a doctor specializing in the disease, and those who get a diagnosis have various problems too. ExaWizards and SANKEN, Osaka University will strive to develop SaMD as a driving force for addressing these issues.
☑ About ExaWizards
ExaWizards has been developing businesses such as the development and implementation of services leveraging AI as well as strategy planning to consistently address social issues since the establishment in 2016. They accumulate their unique algorithms data through their two business segments: “AI Platform Business” that provides solutions to departmental/company-wide issues while handling more than 250 AI/DX-related projects on an annual basis, and “AI Product Business” that develops products to offer solutions to industry-common or social issues identified through the implementation of “AI Platform Business.” Their cumulative numbers of patent applications and acquisitions are 191 and 85 (as of the end of December 2022), respectively. The company also owns advanced technologies in the hardware area such as robots and AI cameras.
For further information about ExaWizards: https://exawizards.com/
☑ About Yagi Laboratory, SANKEN, Osaka University
Yagi Laboratory conducts research on computer vision and image processing. They deal with a wide range of visual information processing-related themes covering the development of basic technologies such as sensors, and the development of intelligent systems aimed to give high-level visual processing functions to a robot. Specifically speaking, Yagi Laboratory handles a variety of image analysis-related research projects, say the individual identification and gender/age estimation based on the world-top-level image-based gait analysis technology and the application of these functions to forensic science and healthcare, the development of basic technologies such as sensors, and biomedical image processing such as endoscopic images and microscope images.
[Profile of Yagi Laboratory, SANKEN, Osaka University]
Location: Department of Intelligent Media, SANKEN, Osaka University 8-1 Mihogaoka, Ibaraki-shi, Osaka
Professor: Yasushi Yagi
URL: http://www.am.sanken.osaka-u.ac.jp/
<Contact for public relations>
E-mail address of the Public Relations Division of ExaWizards Inc.: publicrelations@exwzd.com