RedDress Receives FDA 510(k) Clearance for RD1 System
PARDES-HANNA, Israel, July 10, 2018 /PRNewswire/ -- RedDress Ltd announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its RD1 system.
- PARDES-HANNA, Israel, July 10, 2018 /PRNewswire/ -- RedDress Ltd announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its RD1 system.
- The RD1 System is intended to be used at point-of-care for the safe and rapid preparation of whole blood clot from a small sample of a patient's own peripheral blood.
- The 510(k) clearance allows RedDress to introduce its innovative device technology to the U.S. market, where it will be marketed as the RD1 System for the indications for use cited above.
- "The recent FDA clearance is a significant milestone for RedDress," said Alon Kushnir, Founder and CEO.