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Diabetic Neuropathy Device™

Detect Small & Large Fiber Neuropathy

Diabetic Peripheral Neuropathy (DPN)

The Diabetic Neuropathy Device™ (DND) is the only FDA-registered neuropathy tool that measures both small fiber (temperature) and large fiber (vibration) nerve function in under 3 minutes, providing objective, reproducible results far beyond tuning forks or monofilaments. We own the intellectual property on the DND, and this distinction matters: most diabetes-related amputations stem from large fiber neuropathy that often goes undetected with conventional testing. Supported by Medicare-eligible CPT codes, the DND enables early, accurate detection so providers can intervene sooner, prevent complications, and preserve mobility, while keeping care and revenue in-house.

Test A-Beta, A-Delta & C Fibers—Guideline-Supported

Temperature (Small Fiber)

The Device (DND) Replaces Tuning Forks and Monofilaments...

Kazu Suzuki DPM, Medical Director of the Tower Wound Care Center at the Cedars-Sinai Medical Towers in Los Angeles, CA; Managing Neuropathy And Pain In Wound Care Patients, Podiatry Today; September 2015; 26-27.

Site-Specific Predictive Biomarkers

Vibration (Large Fiber)

Comprehensive Foot Exams

People with diabetes live longer, healthier lives with fewer complications when providers use advanced diagnostic tools that enable earlier identification and intervention. These innovations have transformed diabetes management, improving patient outcomes, reducing long-term costs, and enhancing quality of life. For today’s providers, adopting objective diagnostic tools is no longer optional—it is essential to replace outdated methods like tuning forks (1711) and monofilaments (1938), which are limited in accuracy and reliability.

Neuropathy: The Gateway to Diabetes Complications
Diabetic neuropathy is not just another complication—it is the gateway condition that drives or worsens Alzheimer’s, amputations, balance and gait disorders, cardiovascular disease, depression, fall risk, retinopathy, vascular disease, and chronic wounds. Because neuropathy is often the first sign of systemic nerve damage, early detection is a matter of medical necessity. Without proper testing, patients are silently progressing toward life-altering complications that could have been prevented with timely intervention.

Get Reimbursed for Foot Exams

Both Tests Are Reimbursable—And Critical
Primary care providers are pivotal in prevention, as they are often the first point of contact for patients with symptoms or risks. By utilizing advanced, objective diagnostic methods, providers can deliver accurate diabetic foot exams that include small fiber neuropathy testing and large fiber neuropathy testing—both fully reimbursable by Medicare, Medicaid, and commercial payers. This allows practices to not only ensure better care but also capture revenue that would otherwise be lost to referrals.

Monofilament testing, although inexpensive, has a sensitivity of only 64% for detecting diabetic peripheral neuropathy, according to the Journal of Diabetes Science and Technology. Its limitations often lead to false negatives and false positives, delaying critical care or triggering unnecessary interventions. Outdated tools expose both patients and providers to unnecessary risk, while modern, reimbursable solutions improve accuracy, care, and financial viability.

Test Upper & Lower Extremities

In the U.S., its estimated that up to 85% of lower extremity amputations among persons with diabetes can be prevented with improved foot care programs.

Bild DE, et al. Lower Extremity Amputations in People with Diabetes: Epidemiology and Prevention. Diabetes Care 1989; 12:24-31; CDC MMWR November 01, 1991 / 40(43);737-7

The Diabetic Neuropathy Device™ (DND)
Introduced in 2014, the Diabetic Neuropathy Device™ (DND) is the most significant innovation in neuropathy detection in more than 80 years. Unlike monofilaments or tuning forks, the DND offers objective, standardized, and reliable results across all patient populations, diabetic and non-diabetic. Clinical studies confirm its ability to detect both small fiber and large fiber neuropathy with precision—making it a true breakthrough in neuropathy care.

By adopting the DND, providers can:

Standardize diabetic foot exams nationwide.
Detect risks earlier and justify medical necessity with objective data.
Prevent downstream complications such as amputations, cardiovascular disease, and retinopathy.
Capture reimbursement from Medicare, Medicaid, and commercial insurers.

Better Outcomes, Stronger Practices
Investing in the DND is investing in better care. It empowers providers to intervene earlier, reduce complications, improve patient quality of life, and secure new, recurring revenue streams. With the DND, clinics modernize their approach to diabetic and non-diabetic neuropathy, ensuring that patients receive the best possible management—while practices grow stronger both clinically and financially.

Diabetic Neuropathy Accounts for More Hospitalizations Than All Other Diabetic Complications Combined...

Aaron Vinik, MD, Ph.D., Endocrinologist, Diabetic Neuropathies, February 5, 2018

"Every medical practice should test patients with the DND before referring them to a specialist because it can help identify potential underlying conditions that may require further investigation or treatments." -J. Gonzalez MD, Neurologist

Modern Technology

The Diabetic Neuropathy Device™ (DND) aligns with the latest screening and diagnostic recommendations from the American Diabetes Association (ADA). As the only tool capable of screening for distal symmetric polyneuropathy (DSPN) by assessing both temperature sensitivity (small fiber function) and vibration perception (large fiber function), the DND sets a new standard in neuropathy diagnostics, as emphasized in the ADA’s Diabetic Neuropathy: A Position Statement by the American Diabetes Association.

Tailored neuropathy treatments are essential to address each patient’s unique clinical presentation and underlying pathology while avoiding the risks associated with opioid use. For example, treating painful neuropathy with pain-relieving medications alone may mask loss of protective sensation (LOPS) in the feet, leaving patients vulnerable to foot ulcers and amputation. Early and accurate identification of neuropathy allows providers to intervene at the earliest stages of the condition, effectively reducing risk factors and improving outcomes.

By leveraging advanced tools like the DND, medical providers can enhance their ability to diagnose, monitor, and manage diabetic neuropathy, ultimately protecting patients from severe complications and improving their quality of life.

Don't Change Your Workflow, Just Your Tools!

Two Major Modalities in One Simple-to-Use Handheld Device

The DND objectively measures both small and large fiber neuropathy—enabling earlier detection, full nerve assessment, and more comprehensive diagnostics in one device.

"We regularly use the Diabetic Neuropathy Device™ (DND) to monitor our diabetic patients who are at risk for developing diabetic neuropathy, as well as patients who are already diagnosed with diabetic neuropathy." -C. Soller NP, Endocrinology

Morbidity and Mortalities

Neuropathy is a serious condition that, if not accurately diagnosed and treated promptly, can lead to devastating outcomes, such as amputations of the toes, feet, or legs. The failure to adopt advanced diagnostic tools and procedures has resulted in medical institutions and physicians being held liable for malpractice. A landmark case, Washington v. Washington Hospital (1990)., set legal precedent in the U.S. regarding this issue.

To mitigate these risks, clinicians must stay informed about emerging best practices that are supported by clinical evidence. By adopting advanced technologies and emphasizing prevention, healthcare providers can improve patient outcomes while reducing the risk of complications. Proactive strategies, such as reallocating resources toward early detection and intervention, enable the administration of appropriate therapies. This approach can ultimately decrease the need for frequent inpatient and outpatient visits, significantly enhancing patients' quality of life.

"...by the time a patient fails the monofilament test, he or she may have a profoundly severe neuropathy, and it may be too late to intervene."

Diabetic Neuropathy (DN) is Grossly Underdiagnosed and Undertreated.

Aaron Vinik, MD, PhD, FCP, MACP, FACE, et al, Endocrinologist, Diabetic Neuropathies, February 5, 2018

Identifying the following nerve fibers may increase earlier awareness and interventions:

Aα fibers are large myelinated fibers in charge of motor functions and muscle control.
Aβ fibers are large myelinated fibers with sensory functions such as perception to touch, vibration, and position.
Aδ fibers are small myelinated fibers in charge of pain stimuli and cold perception.
C fibers can be myelinated or unmyelinated and have sensory (warm perception and pain) and autonomic functions (blood pressure and heart rate regulation, sweating, etc.).

"One of the great advantages of using the DND on our diabetic patients who have started to develop diabetic neuropathy, is that showing them their results, often makes the consequences of not taking care of themselves more realistic." -Dr. Steve, Neuropathy Centers

Importance of Specificity

Diabetics that have lower-extremity amputations have lifespans that range between 40% mortality in 1-year, 65% mortality in 3-years, and 80% mortality in 5-years. Diabetic Neuropathy is a serious diabetes complication affecting as many as 50% of people who suffer from pain, and another 50% may be asymptomatic - who are at the highest risk of falls, ulcerations, and amputations. Nerve damage and poor circulation are the most common causes of diabetic foot problems. One of the most underdiagnosed and untreated parts of a comprehensive foot exam is checking the loss of protective sensation (LOPS) in the feet. The diabetic large nerve fiber dysfunction, as measured by vibration, predicts foot ulcerations, amputations, and mortality.

(Painless) Diabetic large nerve fiber dysfunction as measured by vibration Predicts foot ulceration, amputation and mortality.

https://care.diabetesjournals.org/content/32/10/1896

The purpose of a comprehensive diabetic foot exam is to gather as much clinical data about the condition of a person's normal or abnormal condition in the feet of both large and small nerve fibers. A diabetic foot exam also checks people with diabetes for infection, injury, and bone abnormalities. However, over 99% of all medical providers use outdated and subjective tools (tuning fork, invented in 1711 or monofilaments, invented in 1938) to identify a progressive disease. Distal Symmetric Polyneuropathy (DSPN), a glove and stocking distribution, is the most common form of Diabetic Neuropathy (DN) and is recognized as the most troublesome complication of diabetes mellitus leading to the greatest morbidity and mortality, which accounts for the most amount of hospitalizations than all other diabetic complications combined and is responsible for up to 75% of non-traumatic amputations.

(Painful) Diabetic small fiber neuropathy can only be verified with thermal thresholds or skin biopsies.

Aaron Vinik, MD, Ph.D., Endocrinologist, Diabetic Neuropathies, February 5, 2018

The proper diagnosis of diabetic neuropathy should require tools to identify and measure the disorder quantitatively for the different abnormalities that occur to specific nerve fibers. Combining at least two different examinations (large and small fiber) will increase the sensitivity and specificity of detecting DPN. Currently, many medical providers are unaware of reimbursable tools that address both large fiber and small fiber neuropathy, both of which manifest in patients with diabetes. The Diabetic Neuropathy Device™ is the first FDA Cleared multi-objective tool with 15 measurements that identify both large and small nerve fibers in the upper and lower extremities.

"It is imperative that we use our ability to measure quantitatively the different types of defects that occur in the disorder (DN), so the appropriate therapies can be targeted to specific nerve fiber types."

Aaron Vinik, MD, PhD, FCP, MACP, FACE, et al, Endocrinologist, Diabetic Neuropathies, February 5, 2018

Mechanism of Action

The Diabetic Neuropathy Device™ (DND) is a modern, non-invasive tool that identifies early signs of peripheral neuropathy by testing both sensory and autonomic nerve function. The DND operates by assessing the autonomic nervous system’s sudomotor function using a method called the Sympathetic Skin Response (SSR). SSR evaluates the small C-fibers in the skin responsible for sweat responses that are independent of body temperature regulation. These specific fibers are often the first to be affected in small fiber peripheral neuropathy, a condition that impairs the nerves controlling pain and temperature sensations—especially in diabetic patients.

Traditionally, these evaluations have relied on monofilaments and tuning forks. However, the DND advances this process by delivering precise temperature and vibration stimuli, helping to measure nerve integrity quickly and reproducibly. This methodology is supported by clinical guidelines from multiple professional organizations, including the American Diabetes Association (ADA). By using SSR, the DND captures subtle changes in skin potential linked to nerve activity. This test has proven useful not only in diagnosing diabetic polyneuropathy but also in identifying autonomic involvement in conditions like:

Central nervous system disorders (e.g., multiple sclerosis, Parkinson’s)
Peripheral nerve lesions
Reflex sympathetic dystrophy
Erectile dysfunction and other autonomic disorders

With the DND, providers can objectively assess both small and large nerve fiber function—right in the office—in about 3 minutes.

Quantitative Sensory Testing (QST) and Sympathetic Skin Response tests (SSR) are distinct diagnostic procedures employed to assess the nervous system: QST focuses on evaluating sensory function by measuring the perception of stimuli, including touch, temperature, and pressure, commonly used in neurology to assess peripheral neuropathy; whereas SSR assesses the sympathetic nervous system's activity by measuring changes in skin conductance in response to stress or stimuli, often applied in neurology to evaluate autonomic nervous system function, with key differences lying in their respective focuses, stimuli application methods, and measurements. Multiple studies have proven the value of Quantitative Sensory Testing (QST) measures in the detection of subclinical neuropathy (small fiber neuropathy), the assessment of the progression of neuropathy, and the prediction of the risk of foot ulceration (117,129,130). These standardized measures of vibration and thermal thresholds also play an important role as primary efficacy endpoints in multicenter clinical trials.

Related & Reimbursable Assessments

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