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Sonavex Markers Cleared for Medical Imaging Devices
Devices Submissions and Approvals
The FDA granted 510(k) clearance for Sonavex’s soft tissue markers designed to be used in conjunction with ultrasound imaging.
The products, EchoMark and EchoMark LP (low profile), are echogenic, resorbable polymeric implants used to mark tissue sites in surgical patients.
The EchoMark’s ultrasound reflective properties and 3D shape allows surgeons to accurately mark surgical sites for clear ultrasound visualization during important follow-up evaluations.