KARDIOVIS S.R.L.

What KARDIOVIS S.R.L. does

KardioVis S.r.l. is an Italian MedTech company founded in August 2025 in Bologna that develops PREDICT™, an AI-enhanced, non-invasive cardiac monitoring system designed to predict heart failure up to four weeks before an acute event. The end-to-end system combines a patented sensing layer (capturing heart sounds S1-S4 and cardiac time intervals through clothing in a 10-second chest measurement, no skin contact required), proprietary AI-driven signal processing that computes the Myocardial Performance Index (MPI), encrypted data transmission to connected devices, and a digital dashboard for physician review with planned integration into electronic health records. Validation has covered 90+ individuals and 8,000+ cardiac cycles with zero faulty measurements observed, in collaboration with the Cardiology Department of the University of Modena; a Phase 1 study of 120 patients is planned over 2026 with publication targeted by mid-2026. The product is investigational, with parallel MDR (Europe) and FDA (United States) clearance pathways underway and earliest possible market availability targeted for 2027.

The business model is built on three planned revenue streams: device sales of the PREDICT™ hardware for home and clinical use, recurring digital health services tied to ongoing monitoring and the physician dashboard, and a clinical intelligence platform supporting longitudinal data analytics and digital health record integration. The company is targeting two primary customer segments — heart failure patients and at-risk individuals (including the 15% of over-65s silently at risk), and clinicians/cardiologists — through a hybrid go-to-market that combines direct-to-consumer home use with enterprise sales into academic cardiology centers and clinical settings. KardioVis is preparing a seed/pre-Series A funding round to support product industrialization, expanded clinical validation, and regulatory submissions, and currently operates with four co-founders (President Mattia Migani, CEO Gabriele Pieraccini, CTO Giorgio Corbucci, CFO Marco Andolfo) supported by Scientific Advisor Prof. Giuseppe Boriani and Business Advisor Rolf Toft.

Name

KARDIOVIS S.R.L.

Legal name

KardioVis S.r.l.

Website

https://kardiovis.com

Company type

Private

Founded year

2025

Operating status

Operating

Short description

KardioVis is an Italian MedTech startup developing PREDICT™, an AI-enhanced non-invasive cardiac monitor that predicts heart failure up to four weeks before an acute event via a 10-second through-clothing measurement. It serves heart failure patients, at-risk individuals over 65, and clinicians, with MDR and FDA pathways underway.

Ownership category

akta.pro rank

Product category

Cardiac Monitoring Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (33451)

SIC

Instruments For Meas & Testing Of Electricity & Elec Signals (3825)

akta.pro primary industry

Cardiac Monitoring (ECG/Holter/Event/Patch, Loop Recorders) (HLAHACAB)

akta.pro secondary industries

Cardiometabolic RPM & Chronic Disease Management (diabetes, hypertension, CHF, obesity) (HLALAFAA), Cardiology Telemedicine Platforms (HLALAGAB)

Keywords

• Cardiac monitoring devices
• Heart failure prediction
• Non-invasive diagnostics
• MedTech medical devices
• AI cardiac analytics

Headquarters

HQ city

Bologna

HQ country

Italy

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure, Supply Chain

Revenue model

1. Device Sales: Sale of the KardioVis PREDICT hardware device for home and clinical use.
2. Digital Health Services: Ongoing data monitoring, analysis, and physician dashboard services through connected device applications.
3. Clinical Intelligence Platform: Longitudinal clinical intelligence infrastructure supporting structured clinical evaluation over time and digital health record integration.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels4 records

Core offering

KardioVis develops PREDICT™, an end-to-end AI-enhanced non-invasive cardiac monitoring system consisting of a proprietary sensing device that captures heart sounds (S1-S4) and cardiac time intervals through clothing in a 10-second measurement, processes the data to compute the Myocardial Performance Index (MPI), and transmits encrypted results to connected smartphones, tablets, or computers, with an optional physician dashboard for clinical review and integration into digital health records. The system is designed to predict heart failure up to four weeks before an acute event and to serve both home users and clinical settings.

Product overview

KardioVis S.r.l. offers a single unified product: PREDICT™ — an AI-enhanced non-invasive cardiac monitoring system for heart failure prediction. The system consists of a proprietary sensing device that captures cardiac signals (heart sounds and timing information) in 10 seconds without skin contact, processes the data to compute the Myocardial Performance Index (MPI), and delivers insights via a connected device app with optional physician dashboard access. The product is designed for both home and clinical use, with data capable of integration into existing digital health records.

Differentiator

Problem solved

Functional benefit

Brands

• PREDICT™: AI-Enhanced Non-Invasive Heart Failure Monitoring Device. An end-to-end cardiac monitoring system that captures cardiac signals in 10 seconds to predict heart failure up to four weeks before an acute event. Currently in second prototype stage pursuing MDR certification in Europe and FDA clearance in the United States.

Products and services

• KardioVis PREDICT™ AI-enhanced non-invasive cardiac monitoring system comprising a proprietary sensing device that captures heart sounds (S1-S4) and cardiac time intervals through clothing in a 10-second measurement, computes the Myocardial Performance Index (MPI), and transmits encrypted data to connected smartphones, tablets, or computers, with an optional physician dashboard for longitudinal trend analysis and digital health record integration. Designed for heart failure patients, at-risk individuals at home, and clinicians in clinical settings, and capable of predicting heart failure up to four weeks before an acute event.

Quantifiable outcome

• Predicts heart failure up to 4 weeks before acute event occurs
• +3 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability4 records

Feature4 records

Partnerships

Three partnerships are on record, tiered core and flagship.

• Log80coreTechnology or IntegrationKardioVis collaborates with Log80, a digital health and clinical data specialist, to support the development and validation of the Digital Heart platform. Log80 contributes expertise in healthcare digital systems, data management, and clinical workflow integration, strengthening the robustness and scalability of the KardioVis clinical intelligence infrastructure.
• University of Modena - Cardiology DepartmentcoreStrategic or Co-development PartnerClinical validation studies conducted at the Cardiology Department of the University of Modena under Prof. Giuseppe Boriani as Principal Investigator. Phase 1 study planned to enroll 120 patients over 12 months in 2026, with preliminary findings intended for submission to international peer-reviewed cardiology journals by June 2026.
• Prof. Giuseppe BorianiflagshipStrategic or Co-development PartnerProf. Boriani serves as Scientific Advisor and Principal Investigator for clinical validation studies. He is a globally recognized authority in implantable devices, heart failure, and health economics, Full Professor of Cardiology at University of Modena and Reggio Emilia, Chief of Cardiology at Modena University Hospital, Fellow of ESC, EHRA and HFA.

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Boston Scientific: Boston Scientific owns the Preventice ambulatory cardiac monitoring franchise and broader cardiology device portfolio. It is a major incumbent competitor in cardiac monitoring and a former employer of KardioVis's CTO.
• Philips (Cardiac Monitoring): Philips offers a broad suite of cardiac monitoring, telemetry, and ECG analysis products used in hospitals and ambulatory settings. It represents a scaled incumbent in the hospital cardiology channel that KardioVis will need to partner with or displace.
• Abbott: Abbott markets CardioMEMS, an implantable pulmonary artery pressure monitor for heart failure, and a range of cardiac rhythm devices. It is the closest large incumbent directly targeting heart failure monitoring, the same clinical problem KardioVis addresses.
• Medtronic: Medtronic is the incumbent leader in implantable cardiac monitors (Reveal LINQ), pacemakers, and heart failure devices. It represents the dominant established alternative KardioVis is positioning against, especially via CTO Giorgio Corbucci's prior tenure there.

Direct peers

• Eko Health: Eko builds AI-powered digital stethoscopes and cardiac monitoring tools with cloud-based clinician dashboards. Like KardioVis, it combines novel acoustic/electronic sensing with AI-derived cardiac metrics and a clinician-facing software layer, making it a strong functional peer.
• iRhythm Technologies: iRhythm's Zio patch is a wearable ambulatory cardiac monitor using AI to detect arrhythmias from ECG data. It is the closest large-scale analog to KardioVis's continuous monitoring + AI analytics approach, differing mainly in the form factor (adhesive patch vs. through-clothing handheld) and indication (arrhythmia vs. heart failure).
• HeartFlow: HeartFlow commercializes AI-driven, non-invasive cardiac diagnostics (FFR-CT) for coronary disease. It shares KardioVis's positioning of advanced analytics as a non-invasive alternative to invasive diagnostics, with a clinical evidence and reimbursement-led go-to-market.
• AliveCor: AliveCor's KardiaMobile is a consumer-facing, AI-enabled ECG/cardiac monitoring device that detects arrhythmias at home. KardioVis targets the same direct-to-consumer plus clinician dashboard model for heart failure risk, making it a direct peer in non-invasive AI cardiac monitoring.

Emerging players

• Cardiac Insight: Cardiac Insight develops wearable ECG-based cardiac monitoring with AI-driven arrhythmia detection. Like KardioVis, it is a smaller, focused cardiac diagnostics company pursuing novel sensor-plus-AI approaches to compete in cardiac monitoring.
• Biofourmis: Biofourmis is a remote patient monitoring and predictive analytics platform with substantial cardiology and heart failure applications. It overlaps with KardioVis's RPM-plus-AI dashboard layer and chronic disease management use case.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds

Investors

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 KARDIOVIS S.R.L.