Tag: US FDA

SAVE-US trial

FDA grants de novo clearance to Bluegrass Vascular for Surfacer system

Bluegrass Vascular Technologies (Bluegrass Vascular) announced today that the US Food and Drug Administration (FDA) has granted a de novo classification order for its...

Rist Neurovascular radial artery catheter receives FDA 510(k) clearance

Rist Neurovascular recently announced that it has received US Food and Drug Administration (FDA) 510(k) clearance to market the Rist Cath Radial Access Long...
merit

Merit Medical’s EmboCube embolisation gelatin and Torpedo gelatin foam indicated for...

Merit Medical Systems has announced that both its EmboCube (syringe-loaded embolisation gelatin foam) and Torpedo (uniform, preshaped gelatin foam loaded into a cartridge with...
tack

Intact Vascular expands Tack Endovascular System portfolio offering

Intact Vascular has announced US Food and Drug Administration (FDA) pre-market approval (PMA) for the expansion of its Tack Endovascular System (6F) portfolio. The...

Ra Medical Systems receives FDA IDE approval to begin pivotal atherectomy...

Ra Medical Systems has announced approval from the US Food and Drug Administration (FDA) that the company has provided sufficient data to support initiating...
MedAlliance SELUTION SLR

MedAlliance receives third FDA breakthrough device designation for its sirolimus DEB...

MedAlliance, the first drug-eluting balloon (DEB) company in the world to receive US Food and Drug Administration (FDA) breakthrough device designation status for a...

FDA grants breakthrough device designation to Reflow Medical’s Temporary Spur stent...

Reflow Medical announces that the Temporary Spur stent system, a novel retrievable stent technology intended for the treatment of below-the-knee (BTK) peripheral arterial disease,...
reaction to meta analysis

Reaction to the Katsanos et al meta-analysis

Internal BIBA MedTech data show that perceptions on paclitaxel devices have shifted considerably in the twelve months that have elapsed since Konstantinos Katsanos (Patras,...

Merit Medical receives FDA breakthrough device designation for WRAPSODY endovascular stent...

Merit Medical Systems recently announced that it has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA) for the Merit...

Medtronic DCB receives US FDA approval to treat arteriovenous fistula lesions

Medtronic today announced US Food and Drug Administration (FDA) approval of the IN.PACT AV drug-coated balloon (DCB), a paclitaxel-coated balloon indicated for the treatment...

Update on regulatory landscape points to benefits of global collaboration

At the 2019 Vascular Interventional Advances (VIVA) conference in Las Vegas, USA (4–7 November), Misti Malone (US Food and Drug Administration Office for...

Okami Medical announces FDA 510(k) clearance and patent for the LOBO...

Okami Medical today announced 510(k) clearance by the US Food and Drug Administration (FDA) and initial launch of the LOBO vascular occlusion system. The company...

Medtronic announces Shonin approval and launch of the Valiant Navion thoracic...

Medtronic today announced Shonin approval from the Ministry of Health, Labour and Welfare (MHLW) and the launch of the Valiant Navion thoracic stent graft...

Scott Gottlieb resigns as head of US FDA

The commissioner of the US Food and Drug Administration (FDA), Scott Gottlieb, has unexpectedly resigned after serving just shy of two years in the...
shutdown

US government shutdown disrupting FDA work

The US government shutdown means the country’s Food and Drug Administration (FDA) cannot accept new user fees, which means the agency cannot accept new...

First patients treated in United States with OrbusNeich Teleport Microcatheter

The first patients in the United States have been treated using the OrbusNeich Teleport Microcatheter (Teleport; Cardiovascular Systems), which recently received US Food and...

TOBA II shows repairing dissections after angioplasty “clearly augments” outcomes for...

Thomas Zeller (Bad Krozingen, Germany) delves into data and design of the TOBA II (Tack Optimized Balloon Angioplasty II) trial with principal investigator William...

BD acquires TVA Medical, makers of everlinQ endoAVF System

BD (Becton, Dickinson and Company) announced it has completed the acquisition of TVA Medical, a company that develops minimally invasive vascular access solutions...

Medtronic receives US FDA clearance for 200mm and 250mm IN.PACT Admiral...

Medtronic has announced that it has received US FDA approval for 200mm and 250mm lengths of the IN.PACT Admiral drug-coated balloon (DCB) to treat...

Europe braces for harder times in medical device innovation while US...

Countries in the European Union have long been the first to receive new innovations in medical technology, as the EU’s Medical Device Directive (MDD)...

US FDA clears CorPath GRX system for use in peripheral vascular...

Corindus has announced receiving 510(k) clearance from the US Food and Drug Administration (FDA) for use of the CorPath GRX system in peripheral vascular...

LimFlow completes enrolment in US feasibility study

LimFlow has announced completion of enrolment of the original 10-patient cohort in the US feasibility study of the LimFlow percutaneous deep vein arterialisation system....

US FDA approves Gore Viabahn expandable stent graft for iliac artery...

The Gore Viabahn VBX balloon expandable endoprosthesis has received US Food & Drug Administration (FDA) approval for treatment of de novo or restenotic lesions found...

Robert Califf to resign as US FDA commissioner

Robert Califf is to step down as US Food and Drug Administration (FDA) commissioner upon the inauguration of Donald Trump as US President on...

US FDA bans powdered gloves

The US Food and Drug Administration (FDA) has issued a final rule to ban powdered surgical gloves, patient examination gloves and the absorbable powder...

NICE collaborates with US FDA on Payer Communication Taskforce

The UK’s National Institute for Health and Care Excellence (NICE) has announced its participation in the US Food and Drug Administration (FDA)’s Payer Communication...