Brief: Onward Medical Says Receives FDA De Novo Classification And US Market Authorization For ARC-EX System
19/12/2024 17:04
Dec 19 (Reuters) - Onward Medical NV ONWD.BR :
* ONWARD MEDICAL RECEIVES FDA DE NOVO CLASSIFICATION AND US
MARKET
AUTHORIZATION FOR WORLD’S FIRST NON-INVASIVE SPINAL CORD
STIMULATION SYSTEM FOR PEOPLE WITH CHRONIC SPINAL CORD INJURY
* ONWARD MEDICAL NV - FDA AUTHORIZES ARC-EX SYSTEM FOR
CLINIC USE,
HOME USE EXPECTED MID-2025
* ONWARD MEDICAL NV - SEEK CE MARK CERTIFICATION FOR ARC-EX
SYSTEM
IN EUROPE IN EARLY 2025, AUTHORIZATION EXPECTED 2H 2025
Source text: ID:nGNE402MY9
Further company coverage: ONWD.BR
((Reuters.Briefs@thomsonreuters.com;))
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