IRRAS Provides Update on FDA 510(k) Application of IRRAflow™
- Requests for certain technical clarifications and labeling definition -- Financial targets remain unchanged - San Diego, CA, USA, Munich, Germany and Stockholm, Sweden March 12, 2018 – IRRAS AB (NASDAQ Stockholm: IRRAS), a commercial-stage medical technology company focused on designing, developing, and commercializing innovative solutions for various brain pathologies, announced that it received a response from the U.S. Food and Drug Administration (FDA) regarding the company’s 510(k) application for the approval of IRRAflow™, a CE-marked, fully integrated, closed-circuit medical