Tag: FDA clearance

ControlRad

FDA clears the only radiation reduction technology that integrates into mobile...

ControlRad has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its ControlRad Trace. The company has initiated its...

BrightWater Medical’s ConvertX biliary stent system receives FDA clearance

BrightWater Medical has announced that the US Food and Drug Administration (FDA) has cleared the company’s ConvertX biliary stent system for the treatment of...
imaging

FDA grants 510(k) clearance to software suite for molecular imaging and...

The US Food and Drug Administration (FDA) has granted 510(k) clearance to the company DOSIsoft to market its Planet Onco Dose software, for its...
Rivaroxaban

Rivaroxaban receives peripheral arterial disease indication in Europe and USA

Rivaroxaban (brand name Xarelto, Bayer) has received approval from the US Food and Drug Administration (FDA) and the European Commission to reduce risks in...
ProVu

Acessa Health wins FDA nod for 3rd generation ProVu

Acessa Health has announced that the company has received US Food and Drug Administration (FDA) 510(k) clearance for its third generation Acessa ProVu radiofrequency ablation...