Augmenix (Waltham, MA) received FDA clearance for its hydrogel injectable TraceIT Tissue Marker. This marker is useful because it’s visible under CT, MRI, cone beam CT, and ultrasound. The first of its kind, the marker remains stable (but harmless) and visible for at least three months after which time it is resorbed and excreted by the body.
The new marker will help clinicians more confidently fuse MRI and CT images, and make cone beam CT more useful during radiotherapy.
From the announcement:
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.
“When used to mark tumors, other commercial markers create a permanent image artifact in areas of particular interest. Since TraceIT hydrogel absorbs, long term visibility of the site is not compromised,” said Patrick Kupelian, MD, Professor of Radiation Oncology at UCLA.
TraceIT Tissue Marker is the first absorbable tissue marker designed to be CT, MR and ultrasound visible.
Press release: Augmenix Receives FDA Clearance to Market its TraceIT™ Tissue Marker