Tag: FDA
Money-maker or meritable: Is renal denervation out of retirement?
In a paper published in the July 2024 issue of the Journal of Hypertension, Andrew Sharp (University...
SCAI statement seeks to guide physician operators and facilities on renal denervation use
The Society for Cardiovascular Angiography & Interventions’ (SCAI’s) position statement on ...
US FDA seeks to “modernise” clinical trials with new draft guidance
The US Food and Drug Administration (FDA) has released draft guidance with updated recommendatio...
FDA issues two final guidances for including patient perspectives in medical device studies
The US Food and Drug Administration (FDA) has issued two final guidances providing recommendations f...
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...
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 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 ...
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...
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...
