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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 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.

 

 BEST PRACTICE CONFERENCE PROGRAMME

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.

 

 

bestpracticeshow.co.uk



 

En pleno centro de la ciudad de Málaga (Alameda Principal 45 1ºB) el día 19 de Julio se va a realizar un curso desde las 17:30 hasta las 20:00h sobre Neuropatía Diabética y el Estudio de la Conducción Nerviosa dentro del contexto de la importancia del diagnóstico y prevención del pie diabético.

Este curso estará patrocinado por Mediracer, una empresa a la vanguardia de la tecnología médica dentro del campo del diagnóstico con dispositivos EMG o de Estudio de la Conducción Nerviosa.

El contenido y organización de este curso es realizado por neurólogos y podiatras con una gran experiencia en las neuropatías periféricas como es el caso de la Neuropatía Diabética.

Se otorgarán diplomas de asistencia para los especialistas asistentes al curso gratuito certificado por Mediracer.

Las plazas son limitadas por lo que aconsejamos que se ponga en contacto con nuestro distribuidor en España cristinarudilla@medicalstore.es o directamente a info@mediracer.com

 

Atentamente,

Mediracer



Diabetic foot check 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.

 

DPN diabetic peripheral neuropathy test

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 diabetic foot or DPN diabetic peripheral neuropathy. When a clinical examination based on symptoms and disease history gives the indication of DPN, a nerve conduction study is then performed on medial plantar nerve. Stimulating the nerve from the big toe or hallux, the nerve response peak latencies can be compared accurately. When the nerve conduction tests findings are abnormal and it matches the clinical indications it is possible to make a reliable diagnosis of DPN and to estimate the severity. Estimating the severity of the neuropathy helps to determine the proper treatment.

 

Mediracer NCS system

When the responses from the nerve conduction tests are normal and there are symptoms indicative of 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.

 

Mediracer Oy (Ltd)






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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.


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info@mediracer.com



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+358 45 899 2626



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