Some interesting facts from my DD last JuneI did a tremendous amount of DD last June, and this is from my post on the board. It just brought back some excited feelings :) especially now that we know the FDA submission is officailly in! Good read IMO
Overview
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance.
Class I Devices
FDA has exempted almost all class I devices..... "If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and FDA clearance is not required before marketing the device in the U.S." This is part of the letter written by the FDA in 2014 to VentriPoint: Dated: January 22. 2014 Received: January 22, 2014 Dear Mr. Bodtke: We have reviewed your Section 5 10(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). From the MD&A On January 23, 2014, the Company submitted a revised 510(k) application and on March 10, 2014, the Company received clearance from the FDA to market the VMS device for use in adults with PAH in the United States. The VMS was the first ultrasound system to be cleared as substantially equivalent to MRI for right ventricle analysis. (two months between submission and approval, pre-stock split sp @ 1.20 ) The Company has heard from its regulatory advisors that the VMS-PLUS does not need to undergo clinical testing prior to final submission for regulatory approvals and commercial production. Accordingly, the Company is submitting to have the VMS-PLUS included in its product offering for the USA, Canada and Europe. The development and manufacturing facility in Toronto passed an ISO audit in June 2016 (see NR June 24, 2016) and more recently on May 26, 2017, and is ready to manufacture this new model in Canada for worldwide use. Conclusion: VentriPoint has filed for FDA approval, and with this clear evidence it will NOT take as long as some people may think. This is a Class 1 device which is exempted from premarket approval (PMA) application. The World's First whole-heart analysis system is about to be FDA approved....Don't you want to be there when it happens (soon). Hang on to your shares friends. Me, I'm getting ready to load up one last time :) JordanDee