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.


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


What is Best Practice?


Best Practice 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.

Handheld NCS electrodiagnostic devices offer a faster and more effective way for clinicians to identify the presence of Carpal Tunnel Syndrome

TIME IS money when it comes to healthcare. Demand is booming and resources are limited, so anything that services can do to reduce waiting times will be invaluable. However, although early identification may be crucial, it can also be difficult. There is no gold standard to refer to and clinicians will rely on their observations and information they have about a patient’s medical history. Patients may present in various ways and respond differently to treatment regimes.




Current Diagnosis Methods

Clinicians will adopt a number of methods when assessing the needs of patients based on a physical examination, medical histories and screening tests. These include:
Phalen Test: This involves flexing the wrist for 60 seconds. If the patient experiences paraesthesia or pain in the median nerve it will be considered positive.
Tinel Tests: A clinician will lightly tap over the median nerve. If Carpal Tunnel Syndrome is present this may result in a shooting pain.
Durkin Test: This relies on compression of the underlying median nerve. Thumbs are placed on the proximal edge of the nerve to recreate the symptoms of Carpal Tunnel Syndrome.

Each of these is affordable and simple to perform but they are prone to misdiagnosis. The literature review puts the sensitivity of the Phalen test at between 67% to 83% and 40% and 98%. The Tinel test is rated at between 48% and 73% 16 . It’s a wide range which makes it difficult to make a clear diagnosis. Other conditions may present some or all of the symptoms without being Carpal Tunnel Syndrome. Equally it is possible not to have some of the symptoms and still have Carpal Tunnel Syndrome.


Electro Diagnostics

When results are uncertain doctors will move on to electro diagnostics testing which uses nerve conduction studies (NCS) and electromyography (EMG) testing. However, to avoid misdiagnosis, clinicians should consider using these tests to confirm or eliminate the presence of Carpal Tunnel Syndrome.

NCS evaluates how fast electrical signals move through the median nerve in the carpal tunnel and into the muscles. It’s a bit like measuring the flow of water through a garden hose. If this is slowing for any reason it suggests there might be a block or a kink in the hose somewhere down the line. It is this reduction in the flow of electrical signals that leads to altered sensations and muscle weakness.

However, this may not be enough on its own to confirm or eliminate the existence of Carpal Tunnel Syndrome. Clinicians will often use EMG tests alongside NCS. These monitor the muscle itself rather than the nerve by examining how it depolarises when activated. It can be used in two ways. The least invasive approach is to place electrodes on the skin to stimulate the muscle and record its response. Alternatively, some tests may use a small needle which is inserted into the muscle and is used to provide the stimulation. However, this process can be painful.

The advantage of EMG is that it can identify a very subtle loss of muscle function long before the patient experiences any subjective loss of strength. Therefore, when other symptoms are not present, this can highlight a problem which might have gone undetected. It plays a very important role in identifying nerve damage in the earliest stages and enabling prompt and timely treatment.


Next Generation Tests

EMG and NCS tests play an important role in the diagnosis process. They can provide certainty when previous assessments have been inconclusive, and they can help clinicians determine which courses of treatment will be most effective for individual patients. However, they can be expensive with machines costing more than $10,000 and can take time. For health services looking to cut costs and improve turnaround times, that can be a big turn off.

A new generation of point of care (POC) handheld NCS devices is now coming to market which offer a faster and more affordable alternative.



Come and meet us! We are attending at the stand number (#24)

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. The target is to develop reliable and cost-effective products for examination of the most common neurophysiological disorders on primary health care level, requiring only a short training for the operators

MEDIRACER® NCS is a total solution to assess peripheral neuropathies, mainly carpal tunnel syndrome, ulnar entrapment at the elbow and diabetic peripheral neuropathy, in any clinical setting.

Carpal Tunnel Syndrome (CTS) is a common condition that causes a tingling sensation, numbness, and sometimes pain in the hand and fingers. These sensations usually develop gradually and start off being worse during the night. They tend to affect the thumb, index, middle and ring fingers.


Our stand in the BSSH and BAHT Spring 2019 Scientific Meeting

24-26 April 2019 Great Hall, Swansea University Bay Campus

The aims of the BSSH are to promote and direct the development of Hand Surgery, to foster and co-ordinate education, study and research in Hand Surgery, and to disseminate knowledge of Hand Surgery among members of the medical and allied health professions.

The history of the Society is summarised here.

The BSSH sponsors scientific meetings and continuing medical educational courses. Its fellowships, bursaries and research grants support research in Hand Surgery and the training of Hand Surgeons. The Society’s journal is the Journal of Hand Surgery (European volume.

BSSH is a member society of the European Federation of Societies for Surgery of the Hand (FESSH) and the International Federation of Societies for Surgery of the Hand (IFSSH)



Get in touch

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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.
Check our main site: Mediracer – Nerve Conduction Study Device


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+358 45 899 2626

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