Tag: FDA approval

VasQ external support

Laminate Medical announces FDA clearance for VasQ AVF creation device

Laminate Medical Technologies has announced their flagship device, the VasQ External Vascular Support, has been cleared by the US Food and Drug Administration (FDA)...

Penumbra expands computer-aided thrombectomy offering with Lightning Bolt 7 launch

Penumbra has announced the US Food and Drug Administration (FDA) clearance and launch of Lightning Bolt 7, which the company claims is the most...

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...
natural

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...
ILLUMENATE

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...
wound

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-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...