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BioWorld - Saturday, January 31, 2026
Home » FDA gives thumbs up to Aroa’s Enivo tissue regeneration pump and catheter
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FDA gives thumbs up to Aroa’s Enivo tissue regeneration pump and catheter

April 17, 2023
By Tamra Sami
The U.S. FDA has cleared Aroa Biosurgery Ltd.’s 510(k) for its Enivo pump and catheter, which are key components of the company’s new Enivo tissue apposition platform. The device applies negative pressure to a surgical site, helping to reduce fluid accumulation following surgery. It has been cleared for use in removing surgical and bodily fluids from a closed wound for hematoma and seroma prophylaxis following plastic surgery or other general surgeries where large flaps are formed.
Medical technology Regulatory U.S.

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