AMI Corporation's Regulatory Milestone: DNP-AS Digital Biomarker
In a significant stride for medical technology, AMI Corporation, headquartered in Kagoshima, Japan, has received regulatory approval for its innovative digital biomarker device, the DNP-AS, on December 25, 2025. This development is set to push forward the boundaries of healthcare through artificial intelligence, aiming to create a world where optimal medical care is accessible anytime, anywhere, and by anyone.
Overview of the DNP-AS
The DNP-AS is a comprehensive program designed for general phonocardiography. Its primary purpose is to analyze heart sounds and electrocardiogram data collected from standard heart sound meters. This analysis aids in estimating whether a patient suffers from moderate or severe aortic stenosis, thus supporting doctors in deciding whether echocardiography is necessary. Importantly, the results obtained from the DNP-AS are not meant to conclusively diagnose aortic stenosis on their own, but serve as a tool in clinical judgment.
Visionary Leadership
Shinpei Ogawa, CEO of AMI Corporation, stated: "The approval of the DNP-AS marks a milestone in our journey that began in 2013 when I first engaged in the clinical realm of TAVI, a novel treatment for heart diseases. While more treatment options have emerged, the true value lies in connecting patients timely with the right treatment. Thus, the importance of early detection has grown, leading me to found this company and innovate advanced listening devices known as 'super stethoscopes.'"
As AMI Corporation celebrates its 10th anniversary, Ogawa expressed a clear vision: to ensure no heart disease goes undetected. He stated, "Our mission, defined by our pursuit to implement the super stethoscope, is to transform the healthcare landscape, thereby achieving our goal of accessible healthcare for everyone, anytime and anywhere."
An Ongoing Journey
The regulatory approval of the DNP-AS represents a significant achievement, yet Ogawa emphasizes that this is not the end of the road. "This is our starting point. We are committed to systematically realizing our mission of societal implementation as we move forward, step by step."
About AMI Corporation
Founded in November 2015, AMI Corporation is a research-oriented startup focusing on the development of AI-based medical devices and the societal implementation of telemedicine services. The company’s mission revolves around harnessing ‘super stethoscopes’—a term encompassing hardware (Cardio-EGG), software (Cloud Super Examination), technology (AI and SaMD), and extensive medical knowledge—to innovate healthcare access. For interested individuals, AMI provides promotional materials and a detailed overview of its technology, emphasizing its commitment to facilitating effective healthcare solutions around the globe.
To discover more about AMI Corporation’s initiatives or to explore their demo and rental services, visit their
official website or their
YouTube promotional video.
In summary, AMI Corporation is paving the way for future breakthroughs in healthcare through the responsible implementation of AI technologies, ensuring that quality care is universally accessible. This certification of the DNP-AS digital biomarker is not just an approval but a step towards a transformed health environment that prioritizes early disease detection and patient engagement.