Mediracer

Mediracer is preparing to enter the US market after the FDA 510(k) review for premarket notification for the Mediracer® NCS system was successfully completed (SE) for our CTS Carpal Tunnel Syndrome and DPN Diabetic Peripheral Neuropathy measurement.

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.

Thus, “new” devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use. Listings of CDRH Substantially Equivalent 510(k)s are normally available about the 5th of each month for the prior month.

Please see the link below to find the Mediracer’s 510(k)s cleared by FDA.

Mediracer’s FDA 510(k)

Carpal Tunnel Syndrome

Our Nerve Conduction Study

Nerve conducting testing has previously been the exclusive preserve of clinical neurophysiologists although the tests performed are not complicated. There are nerve conduction tests which need specialist skills and equipment to be performed but the testing of the responses from the nerves in the hand is simple to perform when the equipment is designed specifically for the task. Nerve conduction tests do not directly give a diagnosis. The diagnosis is always based on the symptoms and the disease history of the patient. We could compare the nerve conducting testing to testing blood pressure or measuring a patient’s body temperature.

Our NCS for Carpal Tunnel Syndrome

Based on those tests it is not possible to say what causes the abnormal tests results without a clinical examination. The same goes for diagnosing carpal tunnel syndrome (CTS). When a clinical examination based on symptoms and disease history gives the indication of CTS, a nerve conduction study is then performed on the ulnar and median nerves. Stimulating the nerves from the fingers and measuring the responses at the wrist, behind the carpal tunnel, the nerve response peak latencies can be compared accurately. If the median nerve response is slower and the amplitude is lower than the ulnar nerve response, there is a compression in carpal tunnel. When the nerve conduction tests findings are abnormal and it matches the clinical indications it is possible to make a reliable diagnosis of CTS and to estimate the severity of the median nerve compression. Estimating the severity of the compression helps to determine the proper treatment.

When the responses from the nerve conduction tests are normal and there are symptoms indicative of CTS, the symptoms can be caused by neck problems or another pathology. These patients need to be sent to see a specialist for further examination. The same goes for when the responses measured can’t be interpreted reliably due to a lack of clearly defined response peaks. Generally, nine out of ten diagnoses can be confirmed using Mediracer NCS system. This makes a confirmed diagnosis possible in any clinic without need to send patients away for nerve conduction studies. This saves time and money both of which are limited in today’s health care systems. This kind of Point Of Care device will be increasingly common in primary care to help streamline the patient pathway and to save money and resources, these are all important criteria for the development of primary care. carpal tunnel syndrome

Mediracer Oy (Ltd)