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...

Medtronic HeartWare HVAD approved for destination therapy

The US Food and Drug Administration (FDA) has approved Medtronic’s HeartWare HVAD system as a destination therapy for patients with advanced heart failure who...
TherOx' SSO2

US FDA accepts PMA application for TherOx’ SSO2

The US Food and Drug Administration (FDA) has accepted TherOx’ Premarket Approval (PMA) application for its Supersaturated Oxygen (SSO2) Therapy system. The second-generation system...

US FDA approves coronary indication for ReFlow’s Wingman

ReFlow Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Wingman14C crossing catheter for use in conjunction...

US FDA designates Medtronic HVAD system controller field action as class...

The US Food and Drug Administration (FDA) has classified Medtronic’s recently initiated voluntary field action related to its HVAD system controllers and direct current...

Cobra PzF stent approved for commercial use in the USA

The FDA has approved a nano-coated coronary stent system—CeloNova Biosciences’ Cobra PzF—for use in percutaneous coronary intervention (PCI), specifically to improve coronary luminal diameter....

US FDA grants Fast Track designation to Angionetics’ Generx coronary heart...

The US Food and Drug Administration (FDA) has granted Angionetics “Fast Track” designation for the phase three clinical investigation of Generx cardiovascular angiogenic...

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...

US FDA issues Class I recall for 8040 Leonhard Lang multifunction...

The Leonhard Lang defibrillation electrode DF29N is being recalled due to a connector compatibility issue with the Welch Allyn AED model 10. The FDA...

Bolus version of Aggrastat is now approved in the USA

Medicure has received approval from the US Food and Drug Administration (FDA) for its new “bolus vial” product format for Aggrastat (tirofiban HCl). The...