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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)

 



 

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



Georg Meissner started as a CEO in Mediracer Ltd. and Head Instruments Ltd. at the end of April. Before this he has worked at Specim, Spectral Imaging Oy, as Managing Director and has lead the company successfully to a substantial growth. Prior to this he worked at Nokia in various product and program management roles, including Director of Roadmapping and Concepting.

Georg Meissner holds a Ph.D. in Chemistry from Philipps-Universität Marburg, Germany, and he is both German and Finnish national.

“Mediracer and Head Instruments are two independent companies, but this double position as CEO enables better co-operation between companies from the same business sector”, says Dr. Meissner.

Mediracer’s previous CEO Yoko Keränen will continue in the company as Business Development Director. Head Instrument’s previous CEO and co-founder Jani Katisko will continue as Specialist.

Contact Dr. Georg Meissner:

georg.meissner@mediracer.com // tel. +358 40 517 0182

Head Instruments Ltd. is Oulu, Finland, based startup developing surgical technologies. Head Instruments enables the research, clinical testing and productization of advanced surgical technologies. www.headinstruments.com

Mediracer Ltd. developes Point of Care products in the field of clinical neurophysiology for patient examinations adapted to the needs of primary health care. 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 is part of Head Invest Group. www.mediracer.com



Georg Meissner started as a CEO in Mediracer Ltd. and Head Instruments Ltd. at the end of April. Before this he has worked at Specim, Spectral Imaging Oy, as Managing Director and has lead the company successfully to a substantial growth. Prior to this he worked at Nokia in various product and program management roles, including Director of Roadmapping and Concepting.

Georg Meissner holds a Ph.D. in Chemistry from Philipps-Universität Marburg, Germany, and he is both German and Finnish national.

“Mediracer and Head Instruments are two independent companies, but this double position as CEO enables better co-operation between companies from the same business sector”, says Dr. Meissner.

Mediracer’s previous CEO Yoko Keränen will continue in the company as Business Development Director. Head Instrument’s previous CEO and co-founder Jani Katisko will continue as Specialist.

Contact Dr. Georg Meissner:

georg.meissner@mediracer.com // tel. +358 40 517 0182

Head Instruments Ltd. is Oulu, Finland, based startup developing surgical technologies. Head Instruments enables the research, clinical testing and productization of advanced surgical technologies. www.headinstruments.com

Mediracer Ltd. developes Point of Care products in the field of clinical neurophysiology for patient examinations adapted to the needs of primary health care. 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 is part of Head Invest Group. www.mediracer.com






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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.


Email

info@mediracer.com



Phone Number

+358 45 899 2626



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