Tag: MagicTouch

Concept Medical received IDE approval to investigate safety and efficacy of its MagicTouch Sirolimus Coated Balloon Catheter for the treatment of small coronary artery disease

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 […]

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 […]