Smart-ABI

Name

Smart-ABI

Legal name

Hyperion Medical Technologies, Inc.

Website

https://smartabi.com

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

11–50 employees

Ownership category

akta.pro rank

Product category

Vascular Diagnostic Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Remote Diagnostics & Home Testing Devices (Connected POC/At-Home Diagnostic Readers) (HLAHACAL)

akta.pro secondary industries

Medical Device Connectivity & Interoperability Middleware (MDI, EHR/HL7/FHIR Integration) (HLACAPAJ), Blood Pressure Monitors (Smart Cuffs) (CRACAQAB)

Keywords

• Vascular Diagnostics
• Peripheral Artery Disease
• Ankle Brachial Index
• Diagnostic Medical Devices
• Non-invasive Arterial Testing

Headquarters

HQ city

Addison

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales/Leasing: Sale or lease of Smart-ABI, Smart-ABI+, Smart-LEDA, and Smart-LEDA+ diagnostic devices to healthcare providers across clinical settings. The devices are the primary hardware platform enabling vascular studies.
2. Smart-ABI Hub SaaS Subscription: Cloud-based software-as-a-solution platform with patient management features and secure data hub, available as a subscription for ongoing access to the collaborative care platform.
3. Extended Service Agreements: Monthly extended service agreements for device support and maintenance, starting at $50/month.
4. Clinical Testing Reimbursement (CPT Codes): Healthcare providers using Smart-ABI devices bill for noninvasive vascular studies using CPT codes 93922 (limited bilateral study) and 93923 (complete bilateral study), and sudomotor testing using CPT code 95923. Managed care providers capture HCC codes (HCC 108 and HCC 18) for RAF increases when diagnosing PAD and diabetic neuropathy.

Pricing tiers

Go-to-market motion1 record

Distribution channels4 records

Marketing channels6 records

Core offering

Smart-ABI develops and sells proprietary non-invasive vascular diagnostic medical devices (Smart-ABI, Smart-ABI+, Smart-LEDA+) that detect and assess Peripheral Artery Disease (PAD) using patented Volume Plethysmography Spectral Analysis with wireless Bluetooth cuffs. The hardware is paired with the Smart-ABI Hub, a HIPAA-compliant, HITRUST-certified cloud-based SaaS platform that provides color-coded ABI/PVR/TBI reporting, bidirectional EMR integration, single sign-on, and remote test-result review for clinicians and healthcare organizations.

Product overview

Smart-ABI offers a portfolio of four diagnostic medical devices and one cloud-based software platform. The core products include Smart-ABI (ABI and PVR testing), Smart-ABI+ (adds TBI and microvascular data), and Smart-LEDA+ (adds sudomotor function testing for neuropathy diagnosis). All devices utilize Bluetooth-enabled wireless cuffs with Microsoft Surface Pro tablets and provide color-coded, audio-guided procedures. These devices connect to the Smart-ABI Hub platform, which enables cloud-based report management, EMR integration, patient trending, and collaborative care coordination across care settings.

Differentiator

Problem solved

Functional benefit

Brands

• Smart-ABI: The fast, simple, and accurate ankle brachial index solution for performing rapid non-invasive arterial studies in any care setting.
• Smart-ABI+
• Smart-LEDA+
• Smart-ABI Hub

Products and services

• Smart-ABI A compact, non-invasive vascular diagnostic device that performs Ankle Brachial Index (ABI) and Pulse Volume Recording (PVR) studies to detect Peripheral Artery Disease. It uses patented Volume Plethysmography Spectral Analysis with wireless Bluetooth cuffs, integrates with a Microsoft Surface Pro, and is designed for physician offices, podiatrists, and vascular specialists who want reimbursement-ready ABI/PVR testing without a dedicated technician.
• Smart-ABI+ An expanded version of the Smart-ABI device that adds Toe Brachial Index (TBI) capability to the standard ABI and PVR studies. It enables assessment of toe pressures for patients with non-compressible arteries (e.g., diabetic patients) and is targeted at vascular specialists, podiatrists, and wound-care clinics requiring comprehensive lower-extremity vascular assessment.
• Smart-LEDA+ A combined diagnostic device that performs ABI testing alongside sudomotor (autonomic neuropathy) function testing. It is designed for clinicians screening diabetic and at-risk patients for both Peripheral Artery Disease and autonomic neuropathy, supporting comprehensive diabetic foot assessment in podiatry, endocrinology, and primary-care settings.
• Smart-ABI Hub A HIPAA-compliant, HITRUST-certified cloud-based SaaS platform that ingests test data from Smart-ABI, Smart-ABI+, and Smart-LEDA+ devices and produces color-coded ABI, PVR, and TBI reports. It supports bidirectional EMR integration with the top U.S. EHR systems, Single Sign-On, and remote clinician review of test results. It is sold to individual practices, hospitals, integrated delivery networks, ACOs, and managed care organizations that need enterprise-grade vascular reporting and population-health analytics.
• Smart-ABI Extended Service Agreement

Quantifiable outcome

• 100% sensitivity for detecting PAD when combining PVR with ABI per validation studies (Lewis et al.)
• +4 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• MESI Medical: MESI makes the mTABLET ABI, a smart, tablet-based ABI and TBI measurement system with EMR integration. It is the most direct point-for-point competitor to Smart-ABI, targeting the same primary care, podiatry, and vascular specialist buyers with a connected point-of-care diagnostic platform.
• CardieX (AtCor Medical): CardieX, through its AtCor Medical subsidiary, makes the SphygmoCor and CONNEQT Pulse systems for central arterial waveform analysis and arterial stiffness assessment. It competes directly with Smart-ABI in non-invasive vascular diagnostics targeting cardiovascular risk assessment.
• Itamar Medical (ZOLL Itamar): Itamar Medical, now part of ZOLL, makes the EndoPAT system for endothelial function and vascular diagnostics. It serves similar cardiovascular risk assessment use cases and overlaps with Smart-ABI in vascular diagnostics sold into cardiology and primary care channels.
• Newman Medical: Newman Medical manufactures simple ABI and vascular diagnostic devices including the Quantaflow and ABI-Q systems used in primary care and podiatry. It competes in the same ABI measurement category as Smart-ABI with a more focused, lower-cost product line.
• Huntleigh Diagnostics (Arjo): Huntleigh, part of Arjo, makes Doppler-based vascular assessment systems including handheld Dopplers and ABI kits used in podiatry, vascular labs, and primary care. It is an established direct competitor in the ABI/PVR diagnostic device category.
• Parks Medical Electronics (Natus): Parks Medical Electronics, now part of Natus, makes ultrasonic Doppler systems widely used for ABI measurement in clinical and vascular lab settings. It represents an established legacy competitor in the vascular diagnostic device space.

Broad incumbents

• Omron Healthcare: Omron is a broad incumbent in blood pressure monitoring with clinically validated smart BP monitors used in clinical and home settings. While not a specialist ABI device, Omron competes at the edges by enabling simple BP-based screening and is a reference point for cuff-based measurement credibility.
• GE Healthcare: GE Healthcare is a broad incumbent in patient monitoring, diagnostic cardiology, and vascular ultrasound. While ABI testing is not its core franchise, its installed base in hospitals and integrated monitoring platforms make it a potential bundling threat to point-of-care specialists like Smart-ABI.

Emerging players

• Withings (BPM Core): Withings BPM Core combines a smart blood pressure cuff with ECG and digital stethoscope in a connected device. While consumer-focused, it overlaps with Smart-ABI's cuff-based measurement approach and could emerge as a lower-cost screening alternative in some primary care workflows.
• AliveCor: AliveCor's KardiaMobile and KardiaStation are connected single- and multi-lead ECG devices sold into clinical and consumer channels. While focused on cardiac rhythm rather than ABI, it represents an adjacent connected diagnostic platform targeting overlapping primary care prescribers.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/SmartABIteam
• LinkedInlinkedin.com/company/smart-abi

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 Smart-ABI