Grapefruit USA Inc (GPFT)

[manoa]

What about the advisory committee on the 17-18th? I'd seen this info before but I think they added on to it.

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm187662.htm

On November 18, 2009, the committee will discuss and make
recommendations regarding the agency’s regulatory strategy for computer assisted detection (CADe) devices for radiological devices. CADe devices are devices intended to identify, mark, highlight or in any other manner direct attention to potential abnormalities revealed in radiological data of the human body or imaging device data during interpretation of patient images or patient imaging data by a physician or other health care professional. The committee will discuss two draft guidance documents entitled ‘‘Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data— Premarket Notification [510(k)] Submissions’’ and ‘‘Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data—Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions.’’ These guidance documents can be found on the FDA Web site at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments. Type in the title of the guidance document included in this notice. The guidance documents will also be available as background materials.