Tag: US FDA
US FDA issues alert over potential need for early device replacement...
The US Food and Drug Administration (FDA) has alerted patients, caregivers and healthcare providers about the potential need for early device replacement of Boston...
US FDA approves Cordis’ Mynx Control venous vascular closure device
Cordis recently announced that the US Food and Drug Administration (FDA) has granted premarket approval for its Mynx Control venous vascular closure device (VCD)...
Biosense Webster submits premarket approval application to US FDA for Varipulse...
Biosense Webster has submitted a premarket approval application (PMA) to the US Food & Drug Administration (FDA) for its Varipulse platform. The submission was...
Swiss parliament votes to accept US FDA-approved medical devices
The Swiss Federal Assembly has voted in favour of accepting medical devices with US Food and Drug Administration (FDA) marketing authorisation in Switzerland.
A motion...
FDA issues two final guidances for including patient perspectives in medical...
The US Food and Drug Administration (FDA) has issued two final guidances providing recommendations for including patient perspectives in medical device clinical studies.
As...
Boston Scientific gets FDA 510(k) clearance for Lux-Dx ICM
Boston Scientific has received US Food and Drug Administration (FDA) 510(k) clearance for the Lux-Dx insertable cardiac monitor (ICM) system, a new, long-term diagnostic...
FDA issues IDE for Impella ECP and EUA for Impella RP
Abiomed has received investigational device exemption (IDE) from the US Food and Drug Administration (FDA) for an early feasibility study with a first-in-human trial...
FDA advises close screening of COVID-19 patients receiving hydroxychloroquine
The US Food and Drug Administration (FDA) has issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine, including serious and...
FDA issues new policy on remote monitoring devices for use during...
The US Food and Drug Administration (FDA) has issued an immediately-in-effect guidance that allows manufacturers of certain FDA-cleared non-invasive, vital-sign-measuring devices to expand their...
AtriCure receives clearance for expanded labelling claims for AtriClip devices
AtriCure has received US Food and Drug Administration (FDA) 510(k) clearance of additional labelling claims for AtriClip LAA management devices, including changing the indication...
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...
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...
Robert Califf resigns as US FDA commissioner
Robert Califf has stepped down as US Food and Drug Administration (FDA) commissioner upon the inauguration of Donald Trump as US President on 20...
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 clears St Jude Medical’s EnSite Precision cardiac mapping system
St Jude Medical has announced the US Food and Drug Administration (FDA) clearance of its EnSite Precision cardiac mapping system and Advisor FL circular...