Diabetic Neuropathy Device™ 

2 Tests and 4 Billing Codes

Diabetes & Neuropathy

Our Diabetic Neuropathy Device™ (DND) is the first non-invasive tool cleared by the FDA to identify and measure both large and small nerve fibers in peripheral extremities.

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Temperature (Small Fiber)

Site-Specific Predictive Biomarkers

In the U.S., an 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

Vibration (Large Fiber)

$499 Monthly Rental

Unlimited Testing with Billing Support

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No risk for denied claims

The Diabetic Neuropathy Device™ (DND) is the most important medical device for diabetic neuropathy in the last 80 years. It is 1 device that performs 2 tests (small and large fiber neuropathy), and has 3 reimbursements. It is an essential and efficient tool for identifying the type of neuropathy and grading the level of neuropathy in diabetic patients. Its usage may also prevent the unfortunate need for foot amputations, provide healthcare professionals with highly reimbursable assessments, and lead to individualized therapies. 

DN Accounts for More Hospitalizations than All Other Diabetes Complications Combined...

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

Our state-of-the-art technology ensures excellent outcomes for providers and their patients. It is the only multi-objective tool that is uniquely qualified to meet the new American Diabetes Association (ADA) Diabetes screening and diagnosis recommendations with 'temperature and vibrations' under the new Diabetic Neuropathy: A Position Statement by the American Diabetes Association, which recommends that screening for distal symmetric polyneuropathy (DSPN), should include a careful history and assessment of temperature (small fiber function) and vibration (large fiber function). 

Early recognition, management, and treatment of neuropathy in patients with diabetes are essential. Treatments for neuropathy must be individualized to address the particular manifestation and underlying pathogenesis of each patient's unique clinical presentation without subjecting patients to the potentially harmful side effects of opioids. For instance, when a patient with painful neuropathy is prescribed a medication that eases the pain, it further masks and conceals the loss of protective sensation (LOPS) in the patient's feet and increases the risk of foot ulcers and foot amputation. Thus, reliable identification of individuals in the early stages of the neuropathic process is required to modify risk factors more rigorously.

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.

Mitigating Risks

According to the CDC, missed opportunities to diagnose neuropathy appropriately can ultimately lead to lower-extremity amputations of the toes, feet, or legs. U.S. courts have found medical institutions and physician defendants liable for medical malpractice due to their failure to adopt new technologies or procedures. Having been demonstrated in the case that set legal precedence in the U.S. Washington v. Washington Hospital (1990). Risk mitigation initiatives require clinicians to stay informed of emerging best practices based on clinical evidence. A collective refocusing on prevention and a reallocation of resources can lead to the appropriate therapy, leading to fewer inpatient and outpatient visits and improved quality of life. The Diabetic Neuropathy Device™ (DND) is a modern evidence-based tool that improves productivity, patient outcomes, and an organization's overall reputation for mitigating risks.

"...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."

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.

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:

Importance of Specificity

Diabetic Neuropathy (DN) is often overlooked as a mortality risk because diabetics who 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. Therefore, it is critical that assessing the management of diabetic foot problems be identified through comprehensive foot screenings and exams. 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


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 still use outdated and subjective tools to identify a more advanced 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.

Mechanism of Action

Skin is the largest organ of the body and helps regulate body temperatures and permits touch, heat, and cold sensations. The mechanism of action in identifying nerve fibers may be performed by testing the autonomic nervous system's sudomotor function using the sympathetic skin response (SSR). The SSR specifically tests sudomotor skin fibers that do not participate in thermoregulatory sweating. This methodology is currently performed using monofilaments and tuning forks and is recognized by multiple organizations around the U.S. including the American Diabetes Association (ADA) to diagnose autonomic dysfunction with polyneuropathies. Small fiber peripheral neuropathy primarily or exclusively affects the body, such as the skin and those that mediate pain and thermal sensation.

The sympathetic skin response is a simple, reproducible, and non-invasive test based on modifying the skin potential of peripheral nerves. Sympathetic skin response has been used to diagnose polyneuropathy, erectile dysfunction, central degenerative diseases, multiple sclerosis, brain infarction, reflex sympathetic dystrophies, spinal, and peripheral nerve lesions. The Diabetic Neuropathy Device™ is a modern tool that uses the SSR to help patients discriminate against variable temperature and vibration stimuli. 

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

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