Aroa Biosurgery gets FDA approval on first of Enivo range

The device helps reduce fluid accumulation after surgery. (Image: Aroa Biosurgery)

Wed, 12 Apr 2023

Australian stock exchange-listed Aroa Biosurgery has been given pre-market approval from the US Food and Drug Administration for the first of its Enivo range of products, that promote tissue growth reducing the chance of fluid buildup under the skin. The company said it received FDA 510K approval for its Enivo pump and catheter, which makes it easier to kick off clinical studies and get on the road to pursuing commercial activities.The device applies negative pressure to a surgical site, helping reduce fluid accumulating after surgery, rep...

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