AMI

What AMI does

AMI Inc. (AMI株式会社) is a Japanese privately-held medical-device company founded in November 2015 by cardiologist Dr. Shimpei Ogawa to redefine cardiac auscultation. Its core platform combines the Class II phonocardiograph hardware Cardio-EGG (AMI-SSS01 Series, PMDA approval #30400BZX00218000) — which simultaneously captures heart sounds down to 20 Hz and ECG in roughly one minute using a nurse-operable wireless form factor — with the cloud telemedicine service Cloud ChouShin® (クラウド超診®). A series of PMDA-approved Class II SaMD products layered on top (SSS-Air in July 2025, DNP-HF in September 2025, DNP-AS in December 2025) run proprietary deep-learning models on the captured multimodal signals to estimate plasma BNP levels, aortic stenosis severity, atrial fibrillation and valvular regurgitation, returning reports within minutes.

AMI generates revenue through one-time hardware sales of the Cardio-EGG device plus SSS Pad consumables, recurring Cloud ChouShin® SaaS subscriptions, an own-storefront rental plan ('聴診DX rental'), and the newly launched SaMD products sold as regulated software. Go-to-market combines direct enterprise sales to hospitals, dialysis centers and health-check facilities, channel partners DVx (Nov 2024) and Share Medical (Mar 2025), an MUSVI 'Mado' telepresence integration for 'D to P with N-type' online consultation, government co-deployments (Minamata City, Oguni Public Hospital), and early international expansion via the Mitsubishi Corporation/Fogarty Innovation US accelerator and JETRO's Singapore X-HUB program.

The company is headquartered in Kagoshima with offices in Minamata, Kumamoto, Tokyo and Kobe, research labs embedded at Kumamoto and Kyoto Universities, and a 47-member multidisciplinary team (cardiologists, nurses, biomedical engineers, AI engineers and designers). Cumulative equity funding is ¥2,771 million across rounds from CYBERDYNE/CEJ Capital, Real Tech Japan, Higo Bank Capital, Medical Data Vision, DVx, Higin Capital, NEDO grants and others. Validation milestones include the Circulation Journal First Place Clinical Investigation Award (2025), the 8th Japan Medical Research and Development Grand Award Startup Encouragement Award (2026), and ISO/IEC 27001:2013 certification. AMI's stated vision is to address the shortage of cardiovascular specialists in Japan — particularly in remote islands, rural areas, and dialysis clinics — by enabling non-specialist staff to deliver AI-powered cardiac screening and remote specialist consultation.

Name

AMI

Legal name

AMI株式会社

Website

https://ami.inc

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

AMI Inc. is a Japanese medical-device company that develops the AI-powered 'Super Stethoscope' (Cardio-EGG hardware plus Cloud ChouShin® telemedicine SaaS and multiple PMDA-approved SaMDs) to enable nurse-operable, AI-assisted cardiac screening for hospitals, dialysis centers, rural clinics, and remote-island telemedicine programs.

Ownership category

akta.pro rank

Product category

Cardiac Diagnostic Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Instrument Manufacturing for Measuring and Testing Electricity and Electrical Signals (334515)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Cardiology Telemedicine Platforms (HLALAGAB)

akta.pro secondary industries

SaMD – Imaging & Signal Analysis (AI/ML) (HLACANAG), Cardiometabolic RPM & Chronic Disease Management (diabetes, hypertension, CHF, obesity) (HLALAFAA), Cardiac Monitoring (ECG/Holter/Event/Patch, Loop Recorders) (HLAHACAB), AI/Analytics for RPM (Risk Stratification, Alerts, Predictive) (HLACAFAM)

Keywords

• Cardiac diagnostic devices
• AI medical imaging
• Remote auscultation platform
• Telemedicine software
• Phonocardiograph hardware

Headquarters

HQ city

Minamata

HQ country

Japan

HQ region

Asia

Offices7 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales

Revenue model

1. Medical device hardware sales (Cardio-EGG / AMI-SSS01 Series): One-time sales of the Class II controlled medical device AMI-SSS01 Series (approval #30400BZX00218000) including SSS pad consumables, targeted at medical institutions.
2. Cloud ChouShin SaaS service: Recurring cloud-based AI analysis service (クラウド超診®) that uploads heart sound/ECG data, performs automatic AI analysis, and returns reports within minutes. Includes tier of Doctor-to-Doctor consultation.
3. Medical device rental (聴診DX rental plan): Rental plan for the Cardio-EGG device offered via the company's own storefront, lowering upfront acquisition cost for medical institutions.
4. Capital funding (equity): Cumulative equity funding of 2,771 million yen; capital of 836 million yen (including capital reserve) as of company page. Series A/B/C rounds from financial investors (CYBERDYNE/CEJ Capital, Realtech Japan, Higo Bank, Yamato Social Impact Fund, etc.) and strategic investors.
5. Implementation and customer success services: Onboarding/operations support services around cloud product reading (カスタマーサクセス業務) and IT/DX consulting/operations services delivered to internal stakeholders.

Pricing tiers

Go-to-market motion7 records

Distribution channels8 records

Marketing channels8 records

Core offering

AMI manufactures and sells the Cardio-EGG (Phonocardiograph AMI-SSS01 Series), a Class II controlled medical device that simultaneously captures heart sounds (down to 20 Hz) and ECG in a non-invasive ~1-minute exam, and provides the Cloud ChouShin cloud-based telemedicine service that runs proprietary deep learning models to detect cardiac conditions including aortic stenosis, atrial fibrillation, BNP levels, and valvular regurgitation, returning AI analysis reports within minutes.

Product overview

AMI Inc. is a Japanese medical-device startup offering an integrated platform-plus-modules architecture rather than a single product. The core hardware is the Class II phonocardiograph Cardio-EGG (販売名: 心音図検査装置AMI-SSS01シリーズ, 承認番号 30400BZX00218000), which simultaneously captures heart sounds and ECG. The hardware feeds the cloud telemedicine service Cloud ChouShin® (クラウド超診®), which runs proprietary deep-learning SaMD — Digital Biomarker DNP-AS (aortic stenosis screening), Digital Biomarker DNP-HF (BNP-based heart-failure screening), Phonocardiogram Analysis Program SSS-Air, and an atrial-fibrillation model — to deliver automated reports within minutes. Together these are marketed under the 'Super Stethoscope (超聴診器)' umbrella concept, complemented by the SSS Pad accessory and, since 2025, a technical integration with MUSVI's '窓' telepresence system for D-to-P-with-Nurse remote consultation.

Differentiator

Problem solved

Functional benefit

Brands

• Cardio-EGG (カルディオ・エッグ): Brand name of the AMI-SSS01 Series general-purpose phonocardiograph (Super Stethoscope) medical device, a Class II controlled medical device for non-invasive cardiac auscultation and data capture.
• 超聴診器 (Super Stethoscope)
• クラウド超診® (Cloud ChouShin®)
• デジタルバイオマーカー DNP-HF
• デジタルバイオマーカー DNP-AS
• 心音図解析プログラム SSS-Air
• クラウド健進® (Cloud Kenshin)

Products and services

• Cardio-EGG (Phonocardiograph AMI-SSS01 Series) Class II controlled medical device that simultaneously acquires heart sounds (PCG, down to 20 Hz) and ECG in a non-invasive ~1-minute chest-only examination, usable by nurses and clinical technicians without specialist cardiology training. Made wireless via Bluetooth in 2023. Officially branded Cardio-EGG in November 2025.
• Cloud ChouShin (クラウド超診®) Telemedicine Support System Cloud SaaS service that automatically uploads heart sound and ECG data captured by Cardio-EGG, runs proprietary AI-based waveform analysis (BNP estimation, aortic stenosis, atrial fibrillation, aortic/mitral regurgitation), and returns a structured report within minutes for medical institutions.
• SSS Pad (SSSパッド) Pad accessory placed in contact with the Cardio-EGG device's heart sound sensor during measurement; complementary consumable accessory for the core hardware.
• Digital Biomarker DNP-HF Program medical device (general-purpose phonocardiograph program, Class II SaMD) that analyzes heart sound and ECG data from a general-purpose phonocardiograph to estimate whether plasma BNP is ≥100 pg/mL or <100 pg/mL, supporting heart failure diagnosis (non-confirmatory).
• Digital Biomarker DNP-AS Program medical device (general-purpose phonocardiograph program, Class II SaMD) that analyzes heart sound and ECG data from a general-purpose phonocardiograph to estimate whether aortic stenosis is moderate or greater, supporting the decision of whether echocardiography is required.
• Phonocardiogram Analysis Program SSS-Air Program medical device (Class II SaMD, general-purpose phonocardiograph program) that analyzes heart sound data output from a general-purpose phonocardiograph and records/displays a phonocardiogram for general auscultation examination.
• Remote Auscultation and Reading Service (DtoD) Beta Doctor-to-Doctor beta service that enables physicians using AMI-SSS01 Series devices to share heart sound data over the cloud and receive remote auscultation support from specialists.

Quantifiable outcome

• AI model for aortic stenosis screening: sensitivity 0.90, specificity 0.70 in 203 maintenance hemodialysis patients (vs. specialist auscultation specificity 0.37)
• +4 more outcomes

Named customers11 records

Segments7 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

AI capability7 records

Feature11 records

Partnerships

14 partnerships are on record, tiered minor and core.

• 東レ・メディカル株式会社 (Toray Medical)minorGTM or Marketing Partner · 19 June 2026Toray Medical co-sponsored a luncheon seminar on heart disease care in dialysis patients at the 71st JSDT; CEO Ogawa spoke at Toray Medical's booth mini-seminars.
• 月刊科学雑誌 Newton (Newton Press)minorGTM or Marketing Partner · 26 May 2026AMI featured in the 'Frontline of Medicine — Heart Examination Technology' section of the July 2026 issue of Newton science magazine.
• MUSVI株式会社coreStrategic or Co-development Partner · 30 September 2025Strategic partnership MOU to implement 'D to P with N型オンライン診療' combining AMI's AI-powered 'Super Stethoscope' / Cloud ChouShin® with MUSVI's telepresence system 'Mado' (窓). Aims to enable urban specialists to perform remote auscultation and cardiovascular screening on remote islands and rural areas. Joint deployment plan extends to nursing homes, home healthcare, and international markets.
• 国立大学法人群馬大学 (Gunma University) & 独立行政法人地域医療機能推進機構群馬中央病院 (JCHO Gunma Central Hospital)coreStrategic or Co-development Partner · 1 August 2025Three-party consortium selected for the Gunma Future Co-creation Trial Subsidy. Joint research and development project on integrating AI into the 'Super Stethoscope' for remote diagnosis support and early heart failure detection in cardiac screening, period to Feb 27, 2026.
• 株式会社シェアメディカル (Share Medical)coreChannel Partner/ Reseller/ Distributor · 28 March 2025Basic agreement for business alliance signed. Expands AMI's sales channels and presence in medical institutions alongside the direct sales team.
• ディーブイエックス株式会社 (DVx)coreChannel Partner/ Reseller/ Distributor · 11 November 2024Sales partner contract concluded as part of Series C first close. DVx is positioned as a sales/distribution channel to expand AMI's reach to medical institutions.
• JETRO & Rainmaking (Singapore)coreStrategic or Co-development Partner · 20 September 2024Selected for the X-HUB TOKYO OUTBOUND PROGRAM Singapore course. Program supports Tokyo-based startups' global expansion; AMI exhibited at the SWITCH deep tech event in Singapore (Oct 2024) with Rainmaking as the in-market partner.
• 株式会社Medi-LXminorStrategic or Co-development Partner · 6 October 2023Collaboration announced with Medi-LX.
• NTTスマートコネクト株式会社minorStrategic or Co-development Partner · 19 September 2023Business alliance with NTT Smart Connect and co-hosted telemedicine awareness seminars (e.g., 2023-12-20).
• JETRO & Cambridge Innovation Center (CIC) — Global Startup Acceleration Program (GSAP) Bio/Healthcare coursecoreStrategic or Co-development Partner · 1 September 2023Selected for the Global Startup Acceleration Program (GSAP) Bio/Healthcare course run by JETRO, Cabinet Office, METI, and CIC. International Business Lead Ginga Sato received the Excellence Award at the conclusion (Mar 2024).
• メディカル・データ・ビジョン株式会社 (Medical Data Vision)coreStrategic or Co-development Partner · 1 June 2023Business alliance concluded as part of Series B round close. Joined 7 companies to provide total funding of 910 million yen.
• Mitsubishi Corporation (Americas) & Fogarty InnovationcoreStrategic or Co-development Partner · 1 October 2022Selected for MCA's trial accelerator program; only medical-device company chosen. Four-month program at Fogarty Innovation's 30,000 sq ft incubator in Mountain View, CA to develop US-centric business and regulatory strategies. AMI executives were based on-site.
• Hiroshi SugiyamaminorOthers · 13 September 2022Hiroshi Sugiyama joined as Advisor, Global Business Strategy. New York attorney, formerly with Bank of Japan and a US law firm, advising on overseas M&A and capital markets and supporting Kyushu-based startups.
• 熊本県水俣市 & 国保水俣市立総合医療センター (Minamata City & Minamata Municipal General Medical Center)coreOthers · 1 October 2021Three-party agreement signed 2021-10. Underpins the long-running 'Cloud Kenshin' (クラウド健進®) remote auscultation demonstration project commissioned by Minamata City since FY2018.

Scale indicators12 records

Recent moves9 records

Expansion highlights7 records

Direct peers

• Eko Health: US-based digital stethoscope company with FDA-cleared AI algorithms for atrial fibrillation and heart-murmur detection on its CORE 500 stethoscope. Closest direct competitor to AMI's Cardio-EGG, with comparable cloud-based AI auscultation workflow and a similar nurse/primary-care user proposition.
• StethoMe: Poland-based AI stethoscope company offering a home-use AI auscultation device (StethoMe AI) plus physician-side decision support for respiratory and cardiac sounds. Comparable to AMI in pairing dedicated hardware with cloud-based deep learning inference for screening.

Emerging players

• AliveCor: US company selling KardiaMobile, a single-lead ECG device plus AI for AF detection. AMI's ECG-augmented auscultation covers similar decentralized cardiac-screening use cases but adds heart-sound and valvular-disease screening.
• HeartSciences: US company developing AI-ECG algorithms for cardiac disease detection on its MyoVista wavECG device. Comparable in pairing novel hardware capture with cloud-based AI cardiac screening, though focused on ECG rather than phonocardiogram.
• Anumana: US-based AI cardiac diagnostics company (nference/Anumana) developing ECG-based AI algorithms for heart disease detection with Mayo Clinic collaboration. Comparable as a SaMD-centric cardiac AI startup, though ECG-focused rather than phonocardiogram-focused.
• Ultromics: UK-based cardiac AI company with FDA-cleared EchoWeave platform for echocardiography-based AI diagnosis. Comparable in applying AI to cardiac disease detection and pursuing SaMD regulatory pathways in cardiac care.
• CardioSignal: Finland-based company offering a smartphone-based motion-sensor cardiac screening service (detecting AF and heart failure) as a software-only solution. Comparable as a smartphone/cloud-enabled AI cardiac screening alternative.

Broad incumbents

• iRhythm Technologies: US public company (Zio) providing AI-enabled ambulatory cardiac monitoring. Different product form (patch monitor) but comparable end goal of early, AI-driven arrhythmia detection sold to hospitals and clinicians.

Others

• CYBERDYNE: Japanese cybernics/medical device company and AMI investor (CEJ Fund). Comparable as a Japanese medtech/robotics incumbent and strategic partner in AMI's funding rounds.
• Medical Data Vision: Japanese healthcare data and medical-IT company and AMI's Series B business-alliance partner. Comparable as a Japan-based healthcare data infrastructure provider that pairs with AMI's clinical-evidence pipeline.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/AMIinc_official

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds10 records

Investors21 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about AMI