The Smart-ABI flagship

Find vascular and nerve disease in a single visit.

Smart-LEDA+ is the only wireless device in its class that combines true cuff-based ABI, Toe-Brachial Index, and sudomotor function testing in one point-of-care workflow. LEDA stands for Lower Extremity Disease Assessment: a complete vascular and autonomic-neuropathy picture in about seven minutes.

ABI + TBI + Sudomotor~7-minute full studyMA-operatedOnly device in its class
Smart-LEDA+ kit: four wireless ABI and TBI cuffs, sudomotor electrode pads, and pulse oximeter docked in the tray
The Smart-LEDA+ kit: wireless cuffs, sudomotor electrode pads, and pulse oximeter in one tray.
One workflow, four modalities

A whole-person study, not just an ABI.

Smart-LEDA+ lets clinical teams perform rapid, non-invasive arterial studies and sudomotor function tests with the added accuracy of TBI and microvascular data, in one guided workflow an MA can run.

  • True cuff-based ABI with volume plethysmography records (VPR) waveforms for PAD detection.
  • Toe-Brachial Index (TBI) for patients with incompressible ankle vessels, common in long-standing diabetes, CKD, and advanced age. When to use ABI vs. TBI →
  • Sudomotor function testing to detect peripheral autonomic neuropathy, the earliest sign of autonomic nervous-system dysfunction.
  • Microvascular data for a more complete peripheral nerve and vascular assessment.

Only device in its class

True cuff-based ABI + VPRYes
Toe-Brachial Index (TBI)Yes
Sudomotor / autonomic neuropathyOnly Smart-LEDA+
Full study time~7 min

Competing point-of-care platforms (QuantaFlo, PADnet, MESI mTABLET, Sudoscan) do not combine cuff-based ABI, TBI, and sudomotor testing in one device.

Sources: FDA 510(k) summaries K143094, QuantaFlo (volume plethysmography), K220527, PADnet Xpress (pulse volume recording) and K141872, SUDOSCAN (skin conductance for sudomotor function); MESI mTABLET ABI and TBI product information. None lists cuff-based ABI, TBI and sudomotor testing together. Accessed October 31, 2026.

The differentiator

Why test sudomotor function?

Sweat glands do not decide on their own to sweat; a nerve ending commands them. When sweat glands do not respond correctly, there is usually something wrong with the nerves controlling them, often before any clinical sign or symptom appears.

Earliest indicator

A sensitive early marker of small-fiber neuropathy that can detect autonomic dysfunction even when conventional exams appear normal.

Quantitative & objective

Non-invasive electrical conductance produces quantitative data that integrates with vascular indices (ABI/TBI), so change can be measured over time.

Catch it while reversible

Small nerve fibers can regenerate when the underlying insult is removed, so early detection supports timely, targeted intervention.

Smart-LEDA+ report: Sudomotor Graphics Sample report
Smart-LEDA+ sample report sudomotor graphics: sweat response and cholinergic sympathetic nerve response curves for the left and right foot, in millivolts, against shaded reference bands.

Microcirculatory and sweat response records from a Smart-LEDA+ sample report. Patient details removed. Select the image to view it full size.

Beyond ABI

Additional cardiovascular markers.

Alongside ABI, TBI, and sudomotor results, Smart-LEDA+ surfaces markers that help build a fuller cardiovascular risk picture.

Central Aortic Systolic PressureMarker of the pressure of the aorta.
Peripheral Augmentation IndexMarker of aortic stiffness.
Pulse Wave VelocityMarker of lower-extremity aortic stiffness.
Delta Left & Right ArmMarker of subclavian or axillary stenosis.
90%

Reported accuracy of ABI with VPR waveforms to diagnose PAD.

4

Additional cardiovascular markers: central aortic pressure, augmentation index, pulse wave velocity, and left-right arm delta.

~7 min

Total throughput for both the vascular and sudomotor study.

Documentation and reimbursement

Designed for CPT 93922, 93923 and 95923 documentation.

Smart-LEDA+ runs a vascular study and a sudomotor study in one visit. Each is designed for the documentation its CPT code describes.

CPT 93922

Non-invasive physiologic studies of the extremity arteries at a single level, bilateral. The Smart-LEDA+ vascular study (ABI with VPR waveforms) is designed for its documentation.

CPT 93923

The same studies at multiple levels or with provocative maneuvers, as a complete bilateral study. The Smart-LEDA+ vascular study is designed for its documentation.

CPT 95923

Testing of autonomic nervous system function: sudomotor. The Smart-LEDA+ sudomotor study is designed for its documentation.

Payment for a service a code describes is not guaranteed and depends on documentation and medical necessity. Reimbursement and ROI →

Descriptors: AMA CPT, as quoted by AAPC (93922, 93923) and Aetna Clinical Policy Bulletin 0485 (95921, 95923). Accessed October 31, 2026.

Who it’s for

Built for whole-person, value-based care.

Endocrinology & diabetic care

The sudomotor module is uniquely suited to diabetic autonomic and peripheral neuropathy detection and longitudinal monitoring.

Autonomic neuropathy

Nurse practitioners

Detect autonomic neuropathy and PAD in one test, with a workflow an NP-led practice can run and document from day one.

Early detection

Wound care

Audit-defensible ABI documentation the way claims are reviewed today, plus a neuropathy picture that supports the treatment plan.

Documentation

ACOs & value-based care

Early detection and prevention translate directly to the value-based-care economic model and quality reporting.

Prevention
After you order

We install, we train, we stay.

What happens between the order and your first patient test.

1

On-site installation

A Smart-ABI representative installs Smart-LEDA+ in your practice and integrates it into your workflow, rather than shipping a box.

2

Staff training

Your medical assistants are trained on the Smart-ABI Process, a decision-tree workflow that starts at the front desk, so an MA can run the test before the physician enters the room.

3

Smart-ABI Hub setup

Hub access is set up so signed, color-coded reports are ready to add to your EMR.

4

Ongoing support

Technical support and customer service continue after installation. The Extended Service Agreement adds Hub access, unlimited support, and the extended software warranty.

From practices using it

What Smart-LEDA+ practices say.

Two of the Google reviews that mention Smart-LEDA+. Quotes are lightly trimmed for length.

★★★★★
“The Smart-LEDA is a two-in-one device that allows us to test for Peripheral Artery Disease and Peripheral Autonomic Neuropathy. It’s a GREAT value proposition”
Ryan Anderson, DPMSalt Lake City, Utah
★★★★★
“We have been using the LEDA-Plus for about a year. It is much better than the prior devices we were using to detect PAD as well as assess neuropathy. Our patients love the quick access to information.”
Jaryl KorpinenPremier Foot and Ankle

Read all reviews →

Questions

Smart-LEDA+ FAQ

What does Smart-LEDA+ test?
A true cuff-based Ankle-Brachial Index (ABI), Toe-Brachial Index (TBI), and sudomotor function testing in one wireless workflow, along with microvascular data. It assesses both peripheral artery disease and peripheral autonomic neuropathy.
How long does a full study take?
About five minutes for the vascular study alone, or roughly seven minutes for both the vascular and sudomotor studies, from entry of patient information to results in hand.
Which CPT codes is Smart-LEDA+ designed for?
The vascular study is designed for CPT 93922 and 93923 documentation and the sudomotor study for CPT 95923. Payment for a service a code describes is not guaranteed and depends on documentation and medical necessity.
Why does sudomotor testing matter?
Sudomotor testing measures the smallest unmyelinated nerve fibers at the foot, among the earliest indicators of autonomic nervous-system dysfunction. It can detect changes before conventional exams appear abnormal, and small nerve fibers can regenerate when the underlying cause is addressed.
How accurate are the tests?
Per Hyperion Medical materials, ABI with volume plethysmography records (VPR) is reported at 90% accuracy to diagnose PAD, and Sweat-C sudomotor testing has been reported at 78%.
Who can run the test?
Smart-LEDA+ is designed for medical-assistant operation, with color-coded, wireless cuffs, directional arrows, one-click activation, and an audio-guided patient setup screen.

See Smart-LEDA+ in your own workflow.

Book a demo and a Smart-ABI specialist will walk your team through patient selection, the MA-operated ABI + TBI + sudomotor workflow, reimbursement, and the report your EMR receives.

Call Schedule a Demo