Brain tumor laser 510(k)
This article was originally published in The Gray Sheet
Executive Summary
Monteris Medical's AutoLITT laser surgery device gains 510(k) clearance, announced May 13. The magnetic resonance imaging-guided system is intended to treat inoperable brain tumors via a probe, passed through a small burr hole in the skull, that heats and coagulates the tumor. The FDA clearance gets the product over one hump towards gaining a bonus Medicare payment designed for newer, more expensive technologies, but CMS is questioning whether AutoLITT may be too similar to a product already available on the market and whether it has enough clinical data to qualify (1"The Gray Sheet" May 11, 2009, p. 14)