Tag : designation

Neurology

FDA Grants Breakthrough Device Designation for neuroQUERTY software for Parkinson’s Disease Management Platform

Newsemia
The FDA has granted breakthrough device designation to nQ Medical’s neuroQUERTY software, which is designed to monitor brain health and Parkinson’s disease progression. Breakthrough device status is given to medical devices that have...
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Samenvatting: Concept Medical Inc. krijgt ‘Breakthrough Device Designation’ van de FDA voor zijn MagicTouch AVF Sirolimus gecoate ballon

Newsemia
TAMPA, Fla.–(BUSINESS WIRE)–Concept Medical Inc. (CMI) heeft van de Amerikaanse Food and Drug Administration (FDA) de “Breakthrough Device Designation” gekregen van de Amerikaanse Food and...
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Concept Medical Inc. Recibió la “Breakthrough Device Designation” de la FDA para el Balón Recubierto con Sirolimus de AVF MagicTouch

Newsemia
TAMPA, Florida–(BUSINESS WIRE)–Concept Medical Inc. (CMI) recibió la “Breakthrough Device Designation” (Designación de dispositivo innovador) de la Administración de Medicamentos y Alimentos (Food and Drug...
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Concept Medical obtient la « désignation de dispositif révolutionnaire » octroyée par la FDA pour le MagicTouch AVF, son ballonnet à élution de sirolimus

Newsemia
TAMPA, Floride–(BUSINESS WIRE)–Concept Medical Inc. (CMI) s’est vu accorder par l’Agence américaine des médicaments (U.S. Food and Drug Administration, FDA) la « désignation de dispositif...
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Concept Medical Inc. recebeu a “Breakthrough Device Designation” (Designação de dispositivo inovador) da FDA pelo balão revestido com Sirolimus, MagicTouch AVF

Newsemia
TAMPA, Flórida.–(BUSINESS WIRE)–Concept Medical Inc. (CMI) recebeu a “Breakthrough Device Designation” da Administração de alimentos e medicamentos dos EUA (FDA) pelo MagicTouch AVF, seu cateter...

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