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 DateCompany NameTickerDeviceCategoryOutcomeDetails
04/07/2014Myriad Genetics Inc. MYGN BRACAnalysis as a companion testPMA (First module)
04/01/2014STEREOTAXIS INC STXS Vdrive Robotic Navigation System with V-Loop Variable Loop Catheter Manipulator510(k)
02/18/2013EXACT Sciences Corp. EXAS Second module for stool DNA colorectal cancer screening test PMA
12/07/2012EXACT Sciences Corp. EXAS First module for stool DNA colorectal cancer screening test PMA
11/27/2012GIVEN IMAGING LTD GIVN PillCam COLON 2 for visualization of lower gastrointestinal tract Regulatory Clearance
11/13/2012Guided Therapeutics, Inc. GTHP.OB LuViva Advanced Cervical Scan to detect cervical disease PMA (Amended)
09/05/2012Nomir Medical Technologies