Update on the Tomotherapy device. I checked out their site. It seems like a more efficient way to do planning/treatment and probably more idiot proof, especially in local, regional treatment centers where there is no centralized medical team. Other than efficiency and idiotproofness, I don't see a lot of difference between Tomotherapy and the IMRT that Siemens or Varian offers. Many of the treatment planning photos amd dose curve histograms were very similar.

But in a world where the boomers are just starting to show up with cancer now (like myself) and they are running people through radiation treatment centers like cattle (and it's only going to get worse as the younger boomers enter the profile) this device makes sense.

One other item, from a regulatory perspective, if the device was offering new "indications for use" other than what already exists then they would have to file a PMA (Pre-Market Approval) which would take years to get the device on the market.

The device is listed under Section 510(k) [PMN - Pre-Market Notification] of the Food, Drug, and Cosmetic Act (K042739)which means it is "substantially equivalent" to existing devices. This is typically a three month or less process - It took them 29 days to recieve FDA clearance to market. Their regulatory guy must be good.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16446


Gary Allsebrook
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Dx 11/22/02, SCC, 6 x 3 cm Polypoid tumor, rt tonsil, Stage III/IVA, T3N0M0 G1/2
Tx 1/28/03 - 3/19/03, Cisplatin ct x2, IMRT, bilateral, with boost, x35(69.96Gy)
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"You are a mist that appears for a little while and then vanishes" (James 4:14 NIV)