Sonavex Announces Successful Clinical Study of EchoMark & EchoSure and Initiation of the MAFASA Randomized Controlled Trial
FDA IDE approval of Sonavex’s randomized trial comes months after meeting the endpoint of its first clinical study
Baltimore, MD (January 2nd, 2024) – Sonavex, Inc., a privately held medical device company with ultrasound technologies that deliver quantitative blood flow and other critical vascular data at the point of care, announced that it completed its initial clinical study evaluating the ability to use EchoMark & EchoSure to improve the assessment of arteriovenous (AV) fistula maturation for dialysis patients. Following the positive findings from this study, Sonavex was granted approval from the U.S. Food and Drug Administration under an Investigational Device Exemption (IDE) for its randomized controlled trial, MAFASA (Maturation of Arteriovenous Fistula with Automated Sonography Assessments).
