"Bovie Medical (AMEX: BVX) currently has two pending medical device applications at the FDA, and the Company is working toward two additional 510(k) filings for its BOSS orthopedic tissue resection device and Polarian vessel sealing technology. While the two pending medical device applications outlined below do not have firm decision dates, my estimate for a possible FDA decision is currently some time during 3Q-4Q09 based on the review cycle for the Company’s previous medical device filings"...
3Q-4Q! I hope not, too long for me....NEPH will fly another week. I will get some, and sell before news is out..MELA has lousy sensitivity, and specificity, will not replace biopsy as a standard, but could generate some hype.....
Let's examine the facts (1) There's no "Six Month" duration for Class 2 devices listed (2) there IS a 90 day 510K duration period listed and (3) the FDA is since May 15th working on a 4-day work week to accommodate an office move schedule.
Thus, any perceived delay is due simply to an FDA move in progress and not something dire.
As mentioned earlier, the ARGON devices already approved are in all respects similar to what BVX has submitted in their J-Plasma (ICON GS).
Indeed, the ICON GS may work in the same console with ARGON as well as HELIUM. If true, that would make the ICON GS unique as both a superficial AND a deeper penetrating energy device.
Mysterious "Estimates" from commentators of thin pedigree that do not conform to existing FDA published 510K clearance durations and appear out of internet ether to mention microscopic Bovie Medical near an important FDA 510K clearance should be treated with deep skepticism.
BTW there are indications management expects clearance very soon since certain internal schedules have been altered.