Considering Insurance Strategies from SaMD Cases of Susmed and Shionogi
Following the Ministry of Health, Labour and Welfare's announcement of new insurance coverage for SaMD (Software as a Medical Device), Software Regulation and Beyond Next Ventures will hold a free event on May 21st, focusing on 'SaMD Newly Covered by Insurance from June.' Kohei Takeshita and Eiji Takeda will discuss insurance coverage for program medical devices.
📋 Article Processing Timeline
- 📰 Published: May 14, 2026 at 17:00
- 🔍 Collected: May 14, 2026 at 08:32
- 🤖 AI Analyzed: May 14, 2026 at 09:37 (1h 5m after Collected)
## Overview
Yesterday, May 13th (Wednesday), the Ministry of Health, Labour and Welfare newly announced the following contents regarding insurance coverage:
**[Category C2]**
- Product Name: Susmed Insomnia Disorder App Medcle
Company Name: Susmed Co., Ltd.
Insurance Reimbursement Price: 24,100 JPY
- Product Name: ENDEAVORRIDE
Company Name: Shionogi & Co., Ltd.
Insurance Reimbursement Price: 14,500 JPY
**[Regarding the Decision on Evaluated Medical Treatment for Program Medical Devices]**
- Product Name: LIFTON D
Purpose/Method of Use, etc.: Alleviation of mental symptoms in depressed patients with moderate to severe depressive symptoms remaining despite ongoing pharmacotherapy.
Reference: Regarding Insurance Coverage for Medical Devices (Scheduled for listing on June 1, Reiwa 8 / 2026)
Accordingly, to swiftly deliver the latest topics to everyone, we have partially changed the event content to focus on "SaMD newly covered by insurance from June."
*Note: The content regarding trends in the Reiwa 8 (2026) medical fee revision, originally planned, will be omitted this time due to the above news.
We will invite Mr. Kohei Takeshita, who has experience in price determination at the Ministry of Health, Labour and Welfare and also in SaMD insurance from the company side. Together with Mr. Eiji Takeda, Representative Director of Software Regulation Co., Ltd., who will serve as moderator, we will discuss insurance for program medical devices, from practical points to the latest case studies.
View Details
## Date, Time, and Venue
**Date and Time**
May 21, 2026 (Thursday) 18:00〜19:30 (Online part)
**Venue**
On-site Venue
Beyond Next Ventures Event Space
MFPR Nihonbashi Honcho Building 3F, 3-7-2 Nihonbashi Honcho, Chuo-ku, Tokyo 103-0023
Online
Zoom (Planned)
URL will be notified to those who apply by the day of the event.
**Participation Fee**
Free
**Organizers**
Software Regulation
Beyond Next Ventures
## Program Outline
**[Common for Online and Offline]**
18:00 – 18:05
Introduction
18:05 – 18:20
Basic Knowledge of Insurance Coverage for Medical Devices
18:20 – 18:35
Overview of SaMD Covered by Insurance from June
**[Offline Only]**
18:40 – 19:00
Case Studies & Q&A on SaMD Covered by Insurance from June
19:00 – 19:30
Networking
View Details
## Speakers and Panelists
Kohei Takeshita, Lecturer, Department of Advanced Medical Information Technology Research, Jikei University School of Medicine
Responsible for medical device reviews at PMDA for four and a half years, gaining extensive experience in evaluations ranging from clinical trials to in vitro tests. Also served as an instructor for new employee training and pharmaceutical regulatory seminars. Subsequently seconded to the Ministry of Health, Labour and Welfare, where he was in charge of price determination for medical devices, in vitro diagnostics, and regenerative medicine products. After leaving the administration, he gained experience in medical device app insurance listing for medical IT ventures and product development strategy planning for major medical device manufacturers. In his current position at Jikei University School of Medicine, he conducts research on medical IT and medical devices while also fostering ventures and advising medical device manufacturers.
Eiji Takeda, Representative Director, Software Regulation Co., Ltd.
Has experience in pharmaceutical regulatory applications for therapeutic apps at a startup that developed Japan's first therapeutic app. After leaving CureApp, he established a company to support regulatory applications for program medical devices, providing comprehensive domestic and international regulatory services for companies developing SaMD, including not only therapeutic apps but also diagnostic AI software.
## About Recruitment of Advance Questions
Inputting "advance questions" is mandatory for applying to this event. Please fill in the form fields. Your questions will be addressed during the session on the day of the event.
You can also ask questions through an online tool on the day.
*Note: Due to time constraints, we may not be able to answer all questions. Please be aware of this in advance.
View Details
Yesterday, May 13th (Wednesday), the Ministry of Health, Labour and Welfare newly announced the following contents regarding insurance coverage:
**[Category C2]**
- Product Name: Susmed Insomnia Disorder App Medcle
Company Name: Susmed Co., Ltd.
Insurance Reimbursement Price: 24,100 JPY
- Product Name: ENDEAVORRIDE
Company Name: Shionogi & Co., Ltd.
Insurance Reimbursement Price: 14,500 JPY
**[Regarding the Decision on Evaluated Medical Treatment for Program Medical Devices]**
- Product Name: LIFTON D
Purpose/Method of Use, etc.: Alleviation of mental symptoms in depressed patients with moderate to severe depressive symptoms remaining despite ongoing pharmacotherapy.
Reference: Regarding Insurance Coverage for Medical Devices (Scheduled for listing on June 1, Reiwa 8 / 2026)
Accordingly, to swiftly deliver the latest topics to everyone, we have partially changed the event content to focus on "SaMD newly covered by insurance from June."
*Note: The content regarding trends in the Reiwa 8 (2026) medical fee revision, originally planned, will be omitted this time due to the above news.
We will invite Mr. Kohei Takeshita, who has experience in price determination at the Ministry of Health, Labour and Welfare and also in SaMD insurance from the company side. Together with Mr. Eiji Takeda, Representative Director of Software Regulation Co., Ltd., who will serve as moderator, we will discuss insurance for program medical devices, from practical points to the latest case studies.
View Details
## Date, Time, and Venue
**Date and Time**
May 21, 2026 (Thursday) 18:00〜19:30 (Online part)
**Venue**
On-site Venue
Beyond Next Ventures Event Space
MFPR Nihonbashi Honcho Building 3F, 3-7-2 Nihonbashi Honcho, Chuo-ku, Tokyo 103-0023
Online
Zoom (Planned)
URL will be notified to those who apply by the day of the event.
**Participation Fee**
Free
**Organizers**
Software Regulation
Beyond Next Ventures
## Program Outline
**[Common for Online and Offline]**
18:00 – 18:05
Introduction
18:05 – 18:20
Basic Knowledge of Insurance Coverage for Medical Devices
18:20 – 18:35
Overview of SaMD Covered by Insurance from June
**[Offline Only]**
18:40 – 19:00
Case Studies & Q&A on SaMD Covered by Insurance from June
19:00 – 19:30
Networking
View Details
## Speakers and Panelists
Kohei Takeshita, Lecturer, Department of Advanced Medical Information Technology Research, Jikei University School of Medicine
Responsible for medical device reviews at PMDA for four and a half years, gaining extensive experience in evaluations ranging from clinical trials to in vitro tests. Also served as an instructor for new employee training and pharmaceutical regulatory seminars. Subsequently seconded to the Ministry of Health, Labour and Welfare, where he was in charge of price determination for medical devices, in vitro diagnostics, and regenerative medicine products. After leaving the administration, he gained experience in medical device app insurance listing for medical IT ventures and product development strategy planning for major medical device manufacturers. In his current position at Jikei University School of Medicine, he conducts research on medical IT and medical devices while also fostering ventures and advising medical device manufacturers.
Eiji Takeda, Representative Director, Software Regulation Co., Ltd.
Has experience in pharmaceutical regulatory applications for therapeutic apps at a startup that developed Japan's first therapeutic app. After leaving CureApp, he established a company to support regulatory applications for program medical devices, providing comprehensive domestic and international regulatory services for companies developing SaMD, including not only therapeutic apps but also diagnostic AI software.
## About Recruitment of Advance Questions
Inputting "advance questions" is mandatory for applying to this event. Please fill in the form fields. Your questions will be addressed during the session on the day of the event.
You can also ask questions through an online tool on the day.
*Note: Due to time constraints, we may not be able to answer all questions. Please be aware of this in advance.
View Details