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)
You may also be interested in...
Prospects For 2010 New-Tech Inpatient Add-On Payments Appear Bleak
Each of this year's applicants for new-technology add-on Medicare payments are a long shot, CMS suggests in its proposed 2010 inpatient payment 1rule
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.
Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease
Vivalink will provide ECG wearable technology to monitor patients in RSRT’s Vibrant study, which is aimed at assessing autonomic dysfunction in children with Rett syndrome.