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)


We are proud to assist The Best Practice Conference with our distributor Henry Schein

What is Best Practice Conference?

Best Practice Conference is the UK’s national event for general practice. It uniquely brings together over 5,700 decision makers and key influencers working within a practice or group of practices.


GP’s, Dispensing Doctors, Advanced Nurse Practitioners & Practice Managers can attend a carefully crafted programme designed to make sure those who come with questions, leave with answers. This combined with unrivalled networking with key support organisations and of course the exhibitors makes for a very enjoyable two days and is the main reason why so many attend best Practice every year.




The event meets the challenges arising from the NHS Long Term Plan and the GP Contract head on. It is your way to get face to face with those responsible for shaping the future of Primary Care and delivering on the next generation of general practice and primary care. Those at the frontline who need to strive towards a more sustainable model of care.


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)


新しいWindows版(OS 10)Mediracer検査のソフトウェアは、快適なユーザーインターフェイスと、迅速な検査プロセスにより、先生方への多くの利点をもたらし、新たな遠隔解析ソリューションとともに、神経生理学医による検査結果の解析をローカルに提供することが可能です。


〇 Windowsプラットフォームは、データの処理や転送が容易です。

〇 データの保存や印刷を、組織内の複数のコンピュータにプログラムをインストールしてご活用頂けます。

〇 検査ごとの時間が短縮され、検査工程全体が迅速化されます。

〇 簡略化された検査プロセスにより、検査者を的確に導きます。

〇 アルゴリズム方法が変わり、神経応答の質が改善されております。

〇 神経生理学医による検査結果解析のリモート解析ソリューションをローカルに提供します。

〇 拡張レポートは、テスト結果を明確かつ多様に表示します。

〇 より広範囲な神経生理学的検査をサポートします。

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Mediracer Ltd was founded in 2002 to develop Point of Care products in the field of clinical neurophysiology for patient examinations adapted to the needs of primary health care and hand clinics


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+358 45 899 2626

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