MOLECULAR BIOSYSTEMS' ALBUNEX APPROVABLE FOR USE IN DETERMINING FALLOPIAN TUBE PATENCY PROVIDED TRAINING AND LABELING CHANGES MADE, FDA PANEL VOTES 7-0
This article was originally published in The Gray Sheet
Executive Summary
Molecular Biosystems, Inc.'s Albunex is approvable for determining fallopian tube patency provided additional training requirements are specified and minor labeling changes are made, FDA's Radiological Devices Panel concluded at a Feb. 24 meeting in Rockville, Maryland.