Tag: medical device

Geko Device

FDA approval granted to calf stimulation device for patients at high...

UK-based Sky Medical Technology has received US Food and Drug Administration (FDA) 510(k) clearance for its "geko" device for stimulation of the calf muscles...

US FDA releases draft guidance on real-world evidence and medical device...

The US Food and Drug Administration (FDA) has released a draft guidance document entitled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical...