SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : Guided Therapeutics - GTHP
GTHP 0.2700.0%Oct 31 9:30 AM EDT
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
From: caly11/3/2010 3:02:31 PM
   of 118
 
Some recent posts I found on a women's forum (previously linked to Zelda Lily forum) regarding LightTouch. If the first post is accurate, then we should expect something back from the FDA in the next couple of weeks.

October 30, 2010 at 6:35 am

This is a near lock to make it to the market. The approval that the company is seeking is termed ” Pre-Market Approval”. A PMA application generally takes 45 days from the time it is submitted to be, first of all approved as a complete application that the FDA can use to make a decision. Once the application is deemed as ‘accepted’ then the FDA has a self imposed 180 day window to make a decision to approve the device for sale and use (or not). At the time they approve the initial application they then may also grant was is called “expedited review” of the all clinicals submitted. This “expedited review” simply means that there is constant communication between the company and the FDA thru the whole process (hopefully) which will translate in to a faster PMA approval. Hope this helps explain the process better.

November 3, 2010 at 12:22 pm

My friend’s Doctor participated in the Clinic Study and was blown away by the accurate results of the device.She said this will change Cervical Cancer detection.I hope this gets to the public soon.
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  

HomeMailHotSubjectMarksPeopleMarksKeepersSettings
Terms Of UseContact UsCopyright/IP PolicyPrivacy PolicyAbout UsFAQAdvertise on SI
© 2025 Knight Sac Media.  Data provided by Twelve Data, Alpha Vantage, and CityFALCON News