TAMPA, Fla., May 1, 2023 /PRNewswire/ — The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc’s novel MagicTouch Sirolimus Coated Balloon (SCB) for the treatment of Small Vessels (SV) in coronary arteries. US FDA, on the 25th of April 2023, granted […]
Tag: MagicTouch
Concept Medical Inc. Granted ‘Breakthrough Device Designation’ From FDA for Its MagicTouch Sirolimus Coated Balloon
TAMPA, Florida, May 2, 2019 /PRNewswire/ — Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for MagicTouch, its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of coronary in-stent restenosis (ISR). In-stent restenosis (ISR) is the […]