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...
Ra Medical Systems provides update on enrolment in pivotal atherectomy clinical...
Ra Medical Systems a medical device company focused on developing the excimer laser system to treat vascular diseases, has announced that enrollment has reached...
NIH grant sets Mercator research underway for local anti-inflammatory DVT therapy
Mercator MedSystems has recently announced that the DEXTERITY trials research has begun under a technology transfer grant for approximately $300,000 funded by the National...
Interventional News’ top 10 most popular stories of October 2021
October’s top 10 features an interview with Maureen Kohi (Chapel Hill, USA), the chair and professor of Radiology (University of North Carolina), and the...
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...
First case completed in STAND study, the pivotal clinical trial of...
Micro Medical Solutions has announced the first implantation of the MicroStent vascular stent in the US Food and Drug Administration (FDA) randomised, multicentre pivotal...
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...
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...
