Tag: FDA approval
Swiss parliament votes to accept US FDA-approved medical devices
The Swiss Federal Assembly has voted in favour of accepting medical devices with US Food and Drug Administration (FDA) marketing authorisation in Switzerland.
A motion...
FDA approves MicroVention’s lower-profile WEB 17 intrasaccular aneurysm treatment device
The US Food and Drug Administration (FDA) has granted premarket approval (PMA) for the Woven EndoBridge (WEB) 17 system from MicroVention, a US-based subsidiary...
Surmodics’ Pounce thrombus retrieval system gains FDA 510(k) clearance
Surmodics has announced receipt of US Food and Drug Administration (FDA) 510(k) clearance for its Pounce thrombus retrieval system.
The company describes the Pounce system...
Tack Endovascular System receives FDA approval for below-the-knee post-angioplasty dissection repair
Intact Vascular has received US Food and Drug Administration (FDA) approval for the Tack Endovascular System (4F), a novel, minimal metal implant for precision...
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...
MolecuLight receives FDA 510(k) approval for i:X handheld fluorescence imaging device
MolecuLight, a specialist in handheld fluorescence imaging for real-time visualisation of fluorescence in wounds, has received FDA 510(k) clearance for its i:X handheld fluorescence...
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...
Turn Therapeutics wins FDA approval for antimicrobial wound dressing
Turn Therapeutics, a Los Angeles-based pharmaceutical and medical device company, has announced that it has received FDA clearance for its Protego antimicrobial wound dressing,...
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...
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...
