Tag: FDA

US FDA plan shakeup of its 510(k) clearance programme

The US FDA has announced plans to modernise its 510(k) clearance programme for approving medical devices for the US market. Data show that about...

Lutonix 014 DCB gathers first randomised evidence of positive safety and...

Six-month outcomes of the Lutonix BTK IDE trial, a multicentre randomised controlled trial using the Lutonix 014 drug-coated balloon (DCB; BD), has demonstrated that...

Valiant Navion thoracic stent graft receives FDA approval

The US Food and Drug Administration (FDA) has approved Valiant Navion thoracic stent graft system (Medtronic) for the minimally invasive repair of all lesions...

FDA grants IDE approval to Endologix for EVAS2 study of Nellix

Endologix has received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) to commence a confirmatory clinical study (EVAS2) to evaluate the...

US FDA clears Adhezion Biomedical’s SecurePortIV catheter adhesive

The US Food and Drug Administration has cleared Adhezion Biomedical’s  SecurePortIV catheter securement adhesive for marketing. The adhesive is comprised of a cyanoacrylate formulation. It...

Alucent Medical receives FDA approval to begin Natural Vascular Scaffolding clinical...

Alucent Medical has announced that it has received US Food and Drug Administration (FDA) approval to begin Phase 1 human clinical studies of Natural Vascular...

Endologix provides update on the Nellix sealing system US regulatory status

Endologix has met with the US Food and Drug Administration (FDA) regarding its Nellix endovascular aneurysm sealing system (EVAS System). Based upon that meeting and...

Humacyte’s Humacyl receives US FDA expedited review designation

The US Food and Drug Administration (FDA) has granted Humacyte’s Humacyl investigational human acellular vessel (HAV) Regenerative Medicine Advanced Therapy (RMAT) designation. This designation means...

AV Medical’s Chameleon receives expanded indication to include infusion of diagnostic...

AV Medical Technologies has announced that its Chameleon PTA balloon catheter has received FDA clearance for an expanded indication to include infusion of diagnostic...

BTG receives FDA 510(k) clearance for EKOS Control Unit 4.0

BTG has announced US Food and Drug Administration (FDA) 510(k) clearance has been granted to the EKOS Control Unit 4.0. The EKOS system includes an ultrasonic...

Cagent Vascular announces FDA 510(k) clearance of Serranator Alto serration balloon...

Cagent Vascular has announced US Food and Drug Administration 510(k) clearance of its lead product, the Serranator Alto percutaneous transluminal angioplasty serration balloon catheter. The Serranator...

FlowAid receives FDA US market clearance for the FA100 SCCD

Having received CE mark approval in July and Health Canada approval in August of last year, FlowAid Medical Technologies has now received US Food and Drug Administration (FDA)...

Endologix resumes shipments of all sizes of AFX2 systems

Endologix has resumed shipments of all sizes of AFX2 endovascular abdominal aortic aneurysm systems. The large diameter sizes of AFX2 were placed on a temporary...

Avinger announces new FDA clearance for Lumivascular imaging console

Avinger has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Lightbox L250 imaging console. Avinger says that with this...

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...

Merit Medical receives 510(k) clearance for the SwiftNINJA steerable microcatheter

Merit Medical Systems has received 510(k) clearance for the SwiftNINJA steerable microcatheter, covering peripheral and coronary applications. With the exception of Japan, Merit has...

Spectranetics files FDA pre-market approval application for the Stellarex drug-coated balloon

Spectranetics has submitted its pre-market approval application for the Stellarex drug-coated angioplasty balloon to the US Food and Drug Administration (FDA). Stellarex is designed to restore...

US FDA clears Admedus Vascucel

  Admedus Limited has received US Food and Drug Administration (FDA) 510(k) clearance to market VascuCel. “The FDA clearance for VascuCel is important for Admedus as...

US FDA releases draft guidance on real-world evidence and medical device...

The US Food and Drug Administration (FDA) has released a draft guidance document entitled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical...