Let's take a close look here...
IMGG'ers we must congratulate our friends over at BSDM on their 510k approval today. However, let's take a close look at the timing duration in the FDA's 510k process.
Here is a copy & paste of their press releases (start from bottom and read your way up)...
******BSD Medical Receives FDA 510(k) Clearance to Market the MicroThermX Microwave Ablation System August 18, 2010******
BSD Medical Sells Hyperthermia System to Oregon Health & Science University August 2, 2010
BSD Medical Submits Grant Applications under the Qualifying Therapeutic Discovery Project Program July 26, 2010
******BSD Medical Provides Information Requested by FDA for the MicroThermX Ablation System 510(k) Submission July 21, 2010******
BSD Medical Announces Presentation at ASCO of Duke University Clinical Study Using Hyperthermia with Chemotherapy to Treat Bladder Cancer July 15, 2010
******BSD Medical Reports Progress in the FDA Review of MicroThermX Ablation System 510(k) Submission July 12, 2010******
BSD Medical Exhibits MicroThermX® Microwave Ablation System at World Conference on Interventional Oncology June 23, 2010
BSD Medical Reports Hyperthermia Use with Particle Therapy Highlighted at German Society of Radiation Oncology Meeting June 17, 2010
BSD Medical Reports Presentation of Cochrane Review on the use of Hyperthermia in Cervical Cancer Treatment at ESHO 2010 Meeting June 8, 2010
BSD Medical Reports Impressive Results from Clinical Study on Pancreatic Cancer Presented at ESHO 2010 Meeting June 2, 2010
BSD Medical Reports Press Release Issued by The Lancet Oncology on Significant Sarcoma Study using BSD-2000 Hyperthermia System May 4, 2010
******BSD Medical Announces Registered Direct Offering of Common Stock and Warrants in Aggregate Amount of $2.5 Million May 3, 2010******
BSD Medical Reports Study Results Published in Lancet Oncology Demonstrate Improved Survival for Sarcoma Cancer Patients Treated with Hyperthermia April 29, 2010
Clinical Study using the BSD-2000 Hyperthermia System Combined with Chemotherapy to Treat Pediatric Tumors Shows Promise April 22, 2010
TV News Coverage Reports on Duke University Hyperthermia Research Using BSD Medical’s Equipment March 25, 2010
******BSD Medical Files FDA 510(k) Submission to Market Phase II MicroThermX Ablation System March 23, 2010******
Therefore, it took from March 23, 2010 to August 18, 2010 for them to get their 510k clearance! That comes out to about 5 months (aka 150 days - 30 x 5)! And if you notice, the FDA came out with questions and delayed the process somewhat as well. Doesn't that kind of sound familiar to you guys?
Bashers are going to say oh well IMGG has taken 3 years or whatever. You have to remember this is a new review team and a new submission that is interactively in communication with Dean Janes!
We are in excellent shape for approval guys! Let's cross our fingers for it to come any second now!
Good luck to all fellow IMGG'ers!
AI
