Tag: FDA

CDRH adjusts working practices with medical device companies to deal with COVID-19

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has wr...

Revivent transcatheter system receives Breakthrough Device Designation from the FDA

The Revivent transcatheter ventricular enhancement system (Bioventrix) has been granted Breakthr...
patient deaths are under reported said Rita Redberg

Device deaths are under reported, says research letter

A study published as a research letter in JAMA Internal Network has found a “substantial misclas...

Avance steerable introducer given FDA 510(k) clearance

The AVANCE steerable introducer product family (BioCardia) has received US Food and Drug Adminis...
MitraClip in moderate surgical risk patients

MitraClip can be used to treat secondary mitral regurgitation in the USA

The US FDA has approved a new indication for percutaneous edge-to-edge repair (MitraClip, Abbott...

Scott Gottlieb resigns as head of US FDA

The commissioner of the US Food and Drug Administration (FDA), Scott Gottlieb, has unexpectedly ...
shutdown

US government shutdown disrupting FDA work

The US government shutdown means the country’s Food and Drug Administration (FDA) cannot accept ...

Shockwave initiates US pivotal study for coronary intravascular lithotripsy

  Shockwave Medical has initiated its US Food and Drug Administration (FDA) Investigatio...

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...

Medtronic HeartWare HVAD approved for destination therapy

The US Food and Drug Administration (FDA) has approved Medtronic’s HeartWare HVAD system as a de...
TherOx' SSO2

US FDA accepts PMA application for TherOx’ SSO2

The US Food and Drug Administration (FDA) has accepted TherOx’ Premarket Approval (PMA) application ...

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 marke...

US FDA designates Medtronic HVAD system controller field action as class I recall

The US Food and Drug Administration (FDA) has classified Medtronic’s recently initiated voluntar...

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...

US FDA grants Fast Track designation to Angionetics’ Generx coronary heart disease gene therapy

The US Food and Drug Administration (FDA) has granted Angionetics “Fast Track” designation for the p...

US FDA bans powdered gloves

The US Food and Drug Administration (FDA) has issued a final rule to ban powdered surgical glove...

NICE collaborates with US FDA on Payer Communication Taskforce

The UK’s National Institute for Health and Care Excellence (NICE) has announced its participatio...

US FDA issues Class I recall for 8040 Leonhard Lang multifunction defibrillation electrodes

The Leonhard Lang defibrillation electrode DF29N is being recalled due to a connector compatibil...

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 via...