Augmenix Receives FDA Clearance to Market its TraceIT™ Tissue Marker

Augmenix, Inc., an innovative medical technology company focused on utilizing hydrogel technology in the fields of tissue marking and radiation oncology, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its TraceIT Tissue Marker, an absorbable tissue marker visible under CT, MR, cone beam and ultrasound imaging modalities. TraceIT Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. TraceIT hydrogel is intended to mark tissue for at least 3 months after injection.

Radiation oncologists often combine, or fuse, MR and CT images to improve dose planning accuracy. However, most markers do not have equally good visibility on both CT and MR, limiting their usefulness for image fusion. “The excellent dual CT and MR visibility of TraceIT hydrogel will simplify image fusion, allowing for improved soft tissue alignment, resulting in improved radiotherapy plan accuracy and may help with cone beam CT verification during image guided treatment” said Josh Yamada, MD, Radiation Oncologist at Memorial Sloan-Kettering Cancer Center.

TraceIT Tissue Marker is a synthetic hydrogel consisting primarily of water and iodinated cross-linked polyethylene glycol (PEG). Injectable through a fine needle, small hydrogel injections are clearly visible in the lung, breast, prostate and other tissues. The hydrogel remains stable and visible in tissue for three months, long enough for radiotherapy, and then is absorbed and cleared from the body.

source: Augmenix