Tag: Concept Medical

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 gradual re-narrowing of a stented coronary artery lesion, due to […]

Concept Medical Inc. Raises $60mn for Investigational Device Exemption (IDE) for the World’s First Sirolimus-Coated Balloon

SURAT, India, Oct. 9, 2018 /PRNewswire/ — Concept Medical Inc. Raises $60mn For Investigational Device Exemption (IDE) For The World’s First Sirolimus-Coated Balloon. Concept Medical Inc. (CMI) has approached the FDA for an Investigational Device Exemption (IDE) for their Sirolimus-Coated Balloon (DCB). To support this process, they have raised $60mn (for an undisclosed valuation) from cardiologist and […]