AMI Co., Ltd.
[Pharmaceutical approval] AMI’s “Phonocardiogram test device AMI-SSS01 series” becomes wireless (wireless connection) and receives approval for partial changes
An independent government has announced the new model of the “AMI-SSS01 series of phonocardiogram testing devices” developed by AMI Corporation (Head Office: Kagoshima City, Kagoshima Prefecture, Head Office: Minamata City, Kumamoto Prefecture, Representative Director and CEO: Shinpei Ogawa, hereinafter referred to as the “Company”). We have applied for a partial change notification to the Pharmaceuticals and Medical Devices Agency (PMDA), and we would like to inform you that we have received approval from the Ministry of Health, Labor and Welfare.
With this approval, the “AMI-SSS01 series phonocardiogram testing device” is now wireless (wireless connection) and the software has been improved. Furthermore, it can be connected to our company’s “Remote Auscultation Interpretation Service Beta Version*1”, allowing medical professionals to easily conduct examinations “anytime, anyone, anywhere.”
The “AMI-SSS01 series of phonocardiogram testing devices” was developed with support from the New Energy and Industrial Technology Development Organization (NEDO).
*1 A service that allows you to share heart sound data on the cloud and receive remote support from medical professionals who are familiar with auscultation.
[Image: https://prtimes.jp/i/36655/67/resize/d36655-67-ab811cf43f7576863514-0.jpg&s3=36655-67-4567c74d6457dc38537ba36dd45f5c30-1200×600.jpg] -Product overview and outlook-
The “Phonocardiogram Tester AMI-SSS01 Series” can record, save, and play back not only heart sounds but also electrocardiograms in sync. We are also particular about sound quality, and the Ministry of Health, Labor and Welfare has approved performance standards that are stricter than electronic stethoscopes. In addition, signal processing has made it possible not only to save and play back, but also to visualize auscultation.
The “AMI-SSS01 series of phonocardiogram testing devices” can examine organic heart diseases caused by deterioration of the movement of valves and myocardium, such as heart valve disease and heart failure, by acquiring electrocardiograms and phonocardiograms. Heart valve disease is a condition in which an abnormality occurs in any of the four valves in the heart, causing the valves to
malfunction. The number of patients with heart valve disease is increasing year by year as the population ages. In Japan, it is estimated that there are approximately 1.5 million potential patients between the ages of 65 and 74, and approximately 2.35 million potential patients over the age of 75. *2 *3 In addition, the average survival time for heart valve disease after the onset of serious subjective symptoms is short at 3 years, *4 early detection and early treatment can be expected to extend survival time.
On the other hand, heart failure is a condition (≒ syndrome) in which some kind of disorder occurs in the function of the heart, causing various symptoms. The number of patients continues to increase worldwide and is expected to further increase between 2025 and 2035. It is sometimes referred to as a “heart failure pandemic,” likening it to the explosive spread of infectious disease patients. ※5※6 Our “AMI-SSS01 series” phonocardiogram testing device can visualize “heart murmurs,” which are signs of “heart valvular disease” such as aortic valve stenosis, just by placing it on the patient’s chest. Assist diagnosis. The scope of testing for target diseases has been expanded, and early detection and early treatment can be expected. *2 VT Nkomo, et al. Burden of valvular heart diseases: a
population-based study. Lancet. 2006;368:1005-11.
*3 Statistics Bureau, Ministry of Internal Affairs and Communications. Summary of population estimation results April 2020 report (values finalized in November 2019). Available from:
https://www.stat.go.jp/data/jinsui/pdf /202004.pdf (Access date: April 28, 2020)
*4 Ross J Jr, Braunwald E: Aortic stenosis. Circulation 1968; 38 Suppl: 61-7. *5 Japan Heart Foundation Public Interest Incorporated Foundation *6 Shimokawa H, Miura M, Nochioka K, Sakata Y. Heart failure as a general pandemic in Asia. Eur J Heart Fail. 2015 Sep;17(9):884-92. doi: 10.1002/ejhf.319. Epub 2015 Jul 29. Created by AMI Co., Ltd. based on PMID: 26222508.
[Table 3: https://prtimes.jp/data/corp/36655/table/67_1_36d13c6994f30447952f45c32702ff56.jpg] ■Our product page
・Obtained regulatory approval for the “AMI-SSS01 series of
phonocardiogram testing devices”
・AMI has obtained business license as a “Type 2 Medical Device Manufacturing and Sales Business”. Also completed registration as a “medical device manufacturing industry”
-AMI Co., Ltd.-
Our company is a research and development startup from Kyushu that is working on “auscultation DX*” through the research and development of “Super Stethoscope (a telemedicine compatible stethoscope with heart disease diagnosis assist function)”. By developing products that utilize acoustic engineering, electronic engineering, and AI technology and implementing telemedicine services in society, we aim to create a world where everyone can receive high-quality medical care, no matter where they are.
*We not only digitize auscultation, but also use it in medical settings, clinical research, medical education, telemedicine, etc., thereby providing new value to medical settings.
This is our company’s promotional video. Please take a look. URL: https://youtu.be/mVA5YmpVVHk/
[Video 2: https://prtimes.jp/api/movieim.php?url=www.youtube.com/watch?v=mVA5YmpVVHk]
[Table 4: https://prtimes.jp/data/corp/36655/table/67_2_e159ab12d243d6e8118d79ffe5fda26e.jpg]
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