Tag: FDA approval
Alucent Biomedical announces FDA approval to proceed with natural vascular scaffolding...
Alucent Biomedical has received US Food and Drug Administration (FDA) approval to proceed with a phase 1 clinical trial to evaluate the safety and...
Philips receives FDA approval for low-dose drug-coated balloons
Philips has received US Food and Drug Administration (FDA) approval for two Stellarex 0.035” low-dose (200mm and 150mm) drug-coated balloons for the treatment of...
BD receives FDA approval for expansion to drug-coated balloon product line
The US Food and Drug Administration (FDA) has approved expanded sizes of the Lutonix 018 drug-coated balloon (DCB) to treat long superficial femoral artery...
Atherectomy included in pivotal study of QT Vascular’s Chocolate Touch DCB
The FDA has granted approval to include the use of atherectomy for lesion preparation in its ongoing US pivotal study of the Chocolate Touch...
BD’s Lutonix 018 DCB approved by FDA to treat SFA disease
The FDA has granted approval for BD’s 0.018-inch guidewire-compatible Lutonix 018 drug-coated balloon (DCB) for the treatment of long superficial femoral artery lesions in...
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...
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...