Synaptive Medical is pleased to announce that its latest Modus Navigation System (Modus Nav) has achieved CE marking under the European Medical Device Regulation (EU) 2017/745 (MDR). The CE mark was granted following successful completion of the applicable conformity assessment conducted by Synaptive’s Notified Body in accordance with MDR requirements.
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Modus Nav is a planning and intraoperative guidance system designed to enable both open and percutaneous-assisted surgery. Integrated tractography infers the location of the white matter and may be used to inform safer treatment.
“This Class IIb certification represents the highest classification of any Synaptive system to date in the European Union and underscores the company’s commitment to meeting the rigorous requirements of the MDR while continuing to expand its European footprint,” said Michael McDonald, VP Quality & Regulatory Affairs. Modus Nav was previously FDA 510 (k) cleared and has received approvals in other international jurisdictions.
“Achieving MDR CE certification for Modus Nav is a significant commercial milestone for Synaptive,” said Cameron Piron, President and CSO. “It strengthens our ability to support European surgeons with advanced navigation technology and reinforces our long-term commitment to investing in clinical partnerships and market growth across the region.” Synaptive’s quality management system first received MDR (EU) 2017/745 certification on June 17, 2021.
