And the reply
supposedly from the CEO's Facebook page
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vibetech1 Member Profile vibetech1 Share Monday, January 10, 2011 6:46:50 PM
Re: None Post # of 34924
The following is from Deans F.B. page,
Makes you wonder what some of these people's motives are by posting this. The main reason most companies do not post FDA or other government correspondence is how the information can be misunderstood. I've been accused of many things, but it seems obvious some people would like to topple Imaging3 for whatever reason.
First misunderstanding, any NSE device or any device not yet approved is considered a class III. This doesn't mean a PMA application is necessary, just another re-submittal. Items 1, 2 & 3 discuss the clinical images and the study, which t...here is a huge disconnect within the FDA and will be remedied with the next filing as we provided more images than requested for comparison. Some of those images were from the predicate devices website as we wanted to be more inclusive during the study, ie spinal images and 3D/CT images which weren't available from the devices we used and/or couldn't create from those devices.
They discuss a slice image in item 3, which was provided in the format they requested, which when they viewed it had white clipping issues, mostly a problem with their image viewer. We will be submitting our own Dicom image viewer program with the next filing to remedy this.
Item 4, discusses hazard and software analysis, which was provided in the exact same format from a previous 510k approved device application I have used. The newly hired consultants have a format that will remedy this in the next filing.
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Item 5, discusses vibration issues, which was provided and the FDA had more concern with the .2 second acquisition speed which we no longer use as mention in my last response to them.
Item 6, discusses overheating, which a detailed description was provided detailing the devices methods used to monitor and dissipate heat from the x-ray source and system. The newly hired consultants will help explain this in better detail.
Item 7, has been discussed at length which is a very well known issues facing CT scanners as getting access to the patient is difficult. The consultants are working on a more detailed description.
Item 8, discusses how we acquire information faster than the published specifications of the off the shelf detector. This is being remedied by info from the manufacturer of the detector.
Item 9, new issue about the user's manual which the consultants are working on, a technical writing issue not uncommon with preliminary released device manuals.
Item 10, I mistakenly placed a check mark on both prescription and over the counter use. Took a whole second to fix that.
Item 11, is a statement which was taken verbatim from a predicate device the FDA knows they shouldn't have allowed and instead of saying so rejected the language. One of the reasons we have hired FDA legal counsel to hash out this issue.
Item 12, electronic copy. They keep asking for an electronic copy but have problems retrieving information off their own site which is why we always send multiple copies and upload them as well.
Overall nothing over the top, the consultants are busy working each issue, most of which is format related. My main concern, which is why I hired consultants, is that we stop the back and forth, especially with new issues. Having the counsel and consultants to assist us with this process should help avoid the back and forth and move us towards a yes. Believe what you will from the bashers, but ask yourself what is their motivation first.
Vibe
Cpbball3 Member Profile Cpbball3 Share Monday, January 10, 2011 8:38:17 PM
Re: N_B post# 34878 Post # of 34924
facebook.com
The contents of the NSE letter must be released via market wire in the AM and what is written on Dean's FB wall should be included in that PR - or at least he should write up a more formal explanation of what happened.
Just because someone doesnt read this message board does not mean they do not deserve the LEGAL RIGHT to be notified of this informaiton from a publicly traded company that they OWN!
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