Tag: FDA approval

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...
ascyrus-AMDS-stent

Ascyrus dissection stent receives breakthrough approval from FDA

Ascyrus Medical announced today that it has received breakthrough device designation from the US Food and Drug Administration (FDA) for its Ascyrus Medical Dissection...
Lutonix

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...
chocolate

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...