Replies to post #32782 on Grapefruit USA Inc (GPFT)

[bohring]

Please look carefully at the 501k approval of Breast Thermography devices. Their SE determination was only as an adjunct to existing technology. For the perma-longs out there this is a example where the 501k basically made the devices clinically worthless and no insurance company pays for the procedure. The FDA Will not allow any marketing of these devices as a primary detection modality.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm191858.htm

A "negotiated" 501k application that limits the clinical utility of the device and ultimately its values is at issue here. To bypass human clinical trials everything may sacrificed for the sake of an SE determination and pps movement. Not a knock on the device. Just a reality given the liquidity of the company.

Bohring, MD

[chevyman]

KingGuru, after reading your very interesting link "thx" I agree with the statement..and it is also listed..that some NSE letters appear as AI letters, ie;basically a request for a new 510k submission with additional data. I believe that is the path which will be taken and I don't see a need for human data, although we don't know the intended use details. The new team will have all the answers no doubt!