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Technology

SUDOSCAN® Device

The SUDOSCAN® system comprises of a touchscreen computer, a docking station for the hand and foot, and SMART electrodes™.

SUDOSCAN provides a quick and non-invasive stimulation of sweat glands to assess small nerve fibers (C fibers) within 3 minutes.

What does SUDOSCAN measure?

SUDOSCAN® offers a stimulation of the sweat glands in the hands & feet that assess small nerve fibers.

SUDOSCAN® is a cutting-edge test designed to evaluate sweat function with unparalleled accuracy. By targeting the small nerve fibers in the peripheral nervous system that control the sweat glands, SUDOSCAN® delivers quick and reliable results. With just four electrodes and a computer, patients can complete the test in under three minutes, and the device can assess the function of C fibers, which play a crucial role in sweat production.

Learn more about how SUDOSCAN® can help diagnose, measure and monitor sweat-related conditions today.

SWEAT GLAND FUNCTION

A RELIABLE INDICATOR FOR PERIPHERAL AUTONOMIC NEUROPATHY

The sweat glands in our bodies are regulated by small sympathetic C-fibers, and abnormalities in sweat function can be an early sign of distal small fiber neuropathies. Quantitative assessment of sweat response has been suggested as a reliable indicator of autonomic failure and early regeneration of small fibers. In fact, diabetes is one of the most common identifiable causes of small fiber neuropathy. Learn more about the importance of sweat function testing and its potential implications for neuropathy diagnosis and management today.

The American Diabetes Association (ADA) recognizes that sudomotor (sweat) dysfunction is a significant clinical manifestation of diabetic autonomic neuropathy. In addition, evaluating autonomic dysfunction can help identify patients at high risk for cardiac autonomic neuropathy, which carries a significant risk of morbidity and mortality. By measuring motor, sensory, and autonomic function, healthcare providers can gain a more comprehensive understanding of neuropathy and improve patient outcomes. Learn more about the importance of autonomic function testing for diabetic neuropathy today.

Figure 1: The peripheral nervous system is made of large and small fibers. The small, un-myelinated C-fibers are in charge of autonomic functions such as sweating.

The peripheral nervous system is made of large and small fibers. The small, un-myelinated C-fibers are in charge of autonomic functions such as sweating.

Sweat Gland Function Sudoscan

Small fiber autonomic nerves regenerate more quickly than the large fiber nerves upon capsaicin application

Sweat Gland Function Sudoscan

What are the alternatives?

The use of skin biopsy to measure Intraepidermal Nerve Fiber Density (IENFD) or Sweat Gland Nerve Fiber Density (SGNFD) is an accepted surrogate measure of small fiber neuropathy. While skin biopsy is well accepted by the medical community, it has certain limitations as: invasiveness, risk of infection, bleeding, and a limited number of laboratories that can process the sample [6]. The Quantitative Sudomotor Axon Reflex Test (QSART) measures sweat response under controlled humidity and temperature conditions. It requires fairly expensive equipment and is available in few centers.

Image of the Sudoscan hand dock being used by patient

The process

  • The patient is asked to put his hands and feet on large electrodes
  • A small electric tension is applied to the surface to stimulate the sweat glands
  • The results of the response to this stimulation are expressed as :
  • Electrochemical Skin Conductance for SUDOSCAN®, indicating the presence and severity of the small fiber peripheral autonomic neuropathies;
  • Percentage of risk for EZSCAN indicating a risk to develop diabetes.
Sudoscan information system image, the screen says Sudoscan
image of nerves to show we work with neurologist

SUDOSCAN® IN NEUROLOGY

The Effectiveness of SUDOSCAN® in Neurology

Peripheral neuropathy is a condition that arises from damage to the peripheral nerves, including small fiber neuropathy affecting small myelinated nerves (Aδ) as well as unmyelinated nerves (unmyelinated C fibers). The damage to small somatic and autonomic fibers can lead to thermal and pain perception problems, and dysfunction of the cardiovascular, respiratory or digestive systems.

Peripheral neuropathy can be associated with various conditions such as diabetes, metabolic or neurological disorders, and infections. Certain medications or excessive alcohol consumption may also contribute to its development.

 It is possible for peripheral neuropathy to occur in the early stages of disease, highlighting the importance of early detection to enable effective management and reduce the risk of advanced complications.

SUDOSCAN® has been utilized to assess small fiber neuropathies in various diseases and therapeutic areas that involve neurological complications, including:

  • Hereditary amyloidosis, AA, wild type
  • Covid-19
  • Hepatitis C
  • Epilepsy
  • Fabry disease
  • Parkinson’s disease
  • Autoimmune small fiber neuropathy
  • Fibromyalgia
  • Lewy body dimentia
  • Narcolepsy
  • Sjörgen’s syndrome
  • Pure autonomic failure

SUDOSCAN® Technology

SUDOSCAN® is a non-invasive medical device that measures sweat gland function by assessing the electrical conductance of chloride ions. It uses a small direct current applied to both hand and foot sensor plates to measure the conductance of chloride ions, which serves as a quantitative biomarker for sweat gland function in relation to sweat gland innervation.

This technology provides objective and reproducible measurements of sudomotor function, which can be useful for the diagnosis and monitoring of peripheral neuropathies, including diabetic neuropathy and chemotherapy-induced peripheral neuropathy.

SUDOSCAN® Patents

  • “Electrophysiological analysis system and method” (US Patent No. US 8965497B2, European Patent No. EP 1898783B1),
  • “Electrophysiological analysis system” (US Patent No. US 8655443B2, European Patent No. EP 2124736B1),
  • “Assessment of sudomotor function for peripheral diabetic neuropathy evaluation” (US Patent No. US 8934954B2)
  • “Improved electrophysiological analysis system” (US Patent No. US 9636036B2, European Patent No. EP 2890294B1).

CERTIFICATION SYSTEM

ISO 13485:2016

SUDOSCAN device with docks

SUDOSCAN® System

Sudoscan portable mobility Kit

SUDOSCAN® Mobility Kit

Sudoscan information system image, the screen says Sudoscan

SUDOSCAN® Touch Screen

disposable electrode

Dual SMART Electrodes™

Sudoscan Cleaning Kit

Mobillity Cleaning Kit

Image of a hand with screwdriver removing the e-lock

SUDOSCAN® Complete setup using easy start instructions.

Setting up your SUDOSCAN® device and applications is made easy with our step-by-step instructions. You don't need to be tech-savvy; simply follow the instructions in the easy setup guide and your device will be configured and ready for your first patient.

SUDOSCAN® 3 Foot Dock Electrode

SUDOSCAN® Smart Electrode™

The SUDOSCAN® Hand & Foot Docking Systems utilize both reusable and disposable Smart Electrodes™ sensors. These electrodes are designed for easy replacement using a simple slide and lock mechanism. They are compatible with our portable hand and foot docking units, making it convenient to perform sudomotor function tests on the go.

SUDOSCAN & Smart Electrodes™ FDA cleared patented technology.

The SUDOCAN® device is covered by the following patents and designs:
  “Electrophysiological analysis system and method” (US Patent No. US 8965497B2, European Patent No. EP 1898783B1),

“Electrophysiological analysis system” (US Patent No. US 8655443B2, European Patent No. EP 2124736B1),
 
“Assessment of sudomotor function for peripheral diabetic neuropathy evaluation” (US Patent No. US 8934954B2),

“Device for measuring electrophysiological data with impoved reliability” (US Patent No. US 10537272B2),

"Electrodes" (US Designs No. D815746 and D796681, European Designs No. EU0028464100001S and EU0028464100002S)

electrode going into the hand dock

The video highlights the benefits of using SUDOSCAN® as a quick and non-invasive tool for assessing sudomotor function, detecting early neuropathy, monitoring patient progress, and guiding treatment decisions. It also emphasizes the utility of SUDOSCAN® in various clinical settings, including endocrinology, oncology, cardiology, and neurology. Overall, SUDOSCAN® provides a valuable tool for improving patient care and outcomes.