Instrumentation Laboratory (IL) has received US Food and Drug Administration (FDA) 510(k) clearance for GEM Premier 5000, an in-vitro diagnostic (IVD) analyser combined with Intelligent Quality Management 2 (iQM2).
Luminex has secured approval from the US Food and Drug Administration (FDA) for its NxTAG respiratory pathogen panel that is capable of detecting simultaneously 20 clinically relevant viral and bacterial respiratory pathogens.
Cerevast Therapeutics, a US-based medical technology firm, has begun enrolling patients for the Phase III clinical trial to evaluate the use of Clotbust ER ultrasonic headframe, which is meant for the treatment of acute ischemic stroke.
US-based Teleflex’s subsidiary Hotspur Technologies has received US regulatory clearance to market its ARROW GPSCath balloon dilatation catheters in higher rated burst pressure (RBP) and 80cm in length.
US-based Stereotaxis has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Vdrive Robotic Navigation System with V-Sono Intracardiac Echocardiography (ICE) catheter manipulator.