At this share price, I am back into ADMD, but I have a few questions, still trying to catch up. Does anyone know about the 510(k) application status? I saw the press release a few weeks ago but I could not make much out from the news. Is the company planning to resubmit the application this time as Class III medical device, or is there a work around to the current class II application. The PR clearly states "FDA has determined that the product is classified by statute as a Class III medical device, unless the device is reclassified", so I am not sure how the company is receive this.
I looked into the FDA and CE websites to verify how brachytherapy devices are classified. I am not sure what the regulation number for Yitrium-90 is, maybe there is not one for it at this time, but based on my findings, brachytherapy devices are classified as Class II medical device according to the FDA website. I checked with CE, based on their database from June 2010, all brachytherapy devices are classified under rule 7 "Surgically invasive device intended for short term use, 60 mins
Yahoo did not post my entire message, so to continue...
I checked with CE, based on their database from June 2010, all brachytherapy devices are classified under rule 7 as Class IIb medical device.
I still feel that their current application as Class II medical device should be able to provide them with FDA clearance in the next 1-2 months. By the way, IsoRay's Cesium 131 brachytherapy device just got FDA approval, does anyone know what the classification was?
Good questions. I looked up IsoRay's recent approval, and it didn't indicate the level of device, just that it was approved. ADMD hasn't given any indication as to whether they are going to ask the FDA to reconsider their finding it is a class III and assess it as a II, or whether they are going to pursue approval as a class III. I think what may push them to class III is that the first technology they submitted was for radiogel, and not seeds. I don't think there is anything like radiogel on the market ( a substance that self contains itself based on temperature). I think that is why they said they would be submitting applications for other technologies (a.k.a. seeds). I think those could go through based on previously approved technologies. But on the other hand, I wouldn't be surprised given the #$%$ and moaning investors professed to them in the last go around, if ADMD just decided not to let the investors know what they were doing until it was approved, such that we might wake up one day to learn the technology was approved.
I also dug through the 510(k) database and alot of products are approved well after 3 months indicating there is a negotiation period where the fda works with the company.