Medicine Introduction to Programmed Medical Devices Product Examples, Pharmaceutical Affairs, Insurance, Overseas Regulations, Trends in Industry Groups

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Medicine
[Contents introduction]
Regarding the software 『 program medical device (sAMD) 』, which has the purpose of medical devices such as diagnoses and treatments, it explains the basics of related laws and regulations and insurances.
In addition, various examples of program medical device development in Japan and the UNITED states are taken up, and development methods, market entry, regulatory responses, strategies, and issues are introduced.
The content is useful for understanding the overview of program medical devices and considering business models based on actual examples.
[Contents]
01 Program Medical Device Research and Development Support - Replace Introduction -
02 Program Medical Device Case Studies
0201 Program for general-purpose imaging devices : Join
0202 Re-create "treatment" with software : CureApp
0203 Program for supporting endoscopic diagnosis : EndoBRAIN series
0204 Imaging AI : EIRL
0205 Program for supporting sleep care with medical devices : Susamed
0206 Program for supporting pharynx imaging devices + AI systems for diagnosing influenza : nodoca
0207 Intraoperative information fusion platform : OPeLiNK
0208 Program for diagnosing diabetic retinopathy with artificial intelligence : IDx-DR
0209 Notification program for intracranial hemorrhage, etc. : Viz ICH
0210 Echocardiography support application : Caption Guidance
0211 Program for notifying patients of intracranial bleeding, etc. : Viz ICH
0212 Echo support application : Caption Guidance
03 Pharmaceutical affairs
0301 Program Medical Device Regulatory Trends
0302 Guidelines for Developing Behavior Modification Programs
04 Insurance Inclusion Rules
0401 Medical Device Insurance System and Program Medical Device Issues
05 Overseas regulations
0501 Overseas regulations supporting the development of sAMD
06 Trends in industry organizations
0601 Activities of the Japan Federation of Medical Device Industries TOMOCO