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FDA Device Approvals

Medical devices are classified into three main categories based on the risks associated with them and the level of regulatory control. Class I devices need no premarket submission to the FDA prior to sale in the U.S. Class II devices need a 510 (k) for clearance while some are 510 (k)-exempt. Though it is mandatory for the FDA to clear or deny a traditional 510 k premarket notification within 90 days of submission of the application, it may take even six to twelve months, if additional information is required. Class III devices need a PMA (pre-market approval ) submission while some only require a 510 (k). Though the review time for a PMA is 180 days, in reality it may take a longer time.
Submission Date
Company Name
Ticker
Device
Category
Outcome
Details
07/25/2014
Guided Therapeutics, Inc.
GTHP.OB
LuViva Advanced Cervical Scan.
04/07/2014
Myriad Genetics Inc.
BRACAnalysis as a companion test
04/01/2014
STEREOTAXIS INC
Vdrive Robotic Navigation System with V-Loop Variable Loop Catheter Manipulator
02/18/2013
EXACT Sciences Corp.
Second module for stool DNA colorectal cancer screening test
12/07/2012
EXACT Sciences Corp.
First module for stool DNA colorectal cancer screening test
11/27/2012
GIVEN IMAGING LTD
PillCam COLON 2 for visualization of lower gastrointestinal tract
11/13/2012
Guided Therapeutics, Inc.
GTHP.OB
LuViva Advanced Cervical Scan to detect cervical disease
09/05/2012
Nomir Medical Technologies