11.28.14
SpineGuard has earned certification from the Brazilian governmental regulatory authority ANVISA (Agência Nacional de Vigilância Sanitária) following a three-day inspection in Paris. Such certification by ANVISA has recently become the mandatory precursor to register new medical devices for marketing in Brazil.
“This ANVISA certification consolidates our regulatory position in Brazil, an important market for SpineGuard,” said Pierre Jérôme, co-founder and CEO of SpineGuard. “It will allow us to initiate the registration process for the Curved, Cannulated and XS versions of PediGuard in this large market.”
Co-founded in 2009 by Jérôme and Stéphane Bette, former executives at Medtronic Sofamor-Danek and SpineVision, SpineGuard’s primary objective is to establish its PediGuard device as the global standard of care for safer screw placement in spine surgery. The handheld device designed to alert surgeons to potential pedicular or vertebral breaches is cleared for use in the United States and European Union.
Based in Paris, SpineGuard also has offices in San Francisco, Calif.
“This ANVISA certification consolidates our regulatory position in Brazil, an important market for SpineGuard,” said Pierre Jérôme, co-founder and CEO of SpineGuard. “It will allow us to initiate the registration process for the Curved, Cannulated and XS versions of PediGuard in this large market.”
Co-founded in 2009 by Jérôme and Stéphane Bette, former executives at Medtronic Sofamor-Danek and SpineVision, SpineGuard’s primary objective is to establish its PediGuard device as the global standard of care for safer screw placement in spine surgery. The handheld device designed to alert surgeons to potential pedicular or vertebral breaches is cleared for use in the United States and European Union.
Based in Paris, SpineGuard also has offices in San Francisco, Calif.