Tag: US FDA
FDA removes red flag for paclitaxel-coated devices after review finds data...
In a letter to healthcare providers dated 11 July 2023, the US Food and Drug Administration (FDA) communicates that the risk of mortality associated...
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...
ImpediMed gains FDA Breakthrough Device designation for digital renal failure platform
ImpediMed, an Australia-based medical technology company using bioimpedance spectroscopy (BIS) to generate powerful data to improve patient health, has announced that the Sozo digital...
Fist Assist device for focal arm massage and increased vein circulation...
Fist Assist Devices has received US Food and Drug Administration (FDA) 510(k) clearance for use of the Fist Assist FA-1 device in the USA...