这FDA是不是很快就要发放药证了?大概什么时候?
Stereotaxis Receives FDA Clearance of Vdrive(TM) with V-Sono(TM) System
Strengthens Niobe(R) Adoption and Opens Growing ICE Catheter Market to
Company
ST. LOUIS, July 29, 2013 (GLOBE NEWSWIRE) -- Stereotaxis, Inc. (Nasdaq:STXS)
announced today that it has been granted 510(k) clearance by the Food and
Drug Administration (FDA) to market its Vdrive™ Robotic Navigation
System with V-Sono™ Intracardiac Echocardiography (ICE) catheter
manipulator in the U.S. This represents the first FDA clearance for the
Vdrive family of products, which has been utilized in Europe since 2011.