Tag: Concept Medical

Concept Medical is Granted CE Certification for Their Sirolimus Coated MagicTouch Group of Products

Concept Medical B.V. with its headquarters in Tampa, Florida has announced that on 16th October 2019, they have received the CE certification for their MagicTouch group of products. HOEVELAKEN, Netherlands, Oct. 18, 2019 /PRNewswire/ — The CE certified products/brands are as listed below: MagicTouch – PTA (Sirolimus Coated PTA Balloon Catheter) for peripheral arterial disease MagicTouch – ED (Sirolimus […]

Concept Medical Inc. Granted ‘Breakthrough Device Designation’ From the FDA for Its MagicTouch AVF Sirolimus Coated Balloon

TAMPA, Fla.–(BUSINESS WIRE)–Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for MagicTouch AVF, its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of stenotic lesions of Arteriovenous Fistulae or Arteriovenous graft in hemodialysis treatment of renal failure. ​​​​​​The FDA received Concept […]

Concept Medical Inc. Granted 2nd ‘Breakthrough Device Designation’ From the FDA for Its MagicTouch PTA Sirolimus Coated Balloon, for the Treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK) Indication

Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for MagicTouch PTA (Percutaneous Transluminal Angioplasty), its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK). The first ‘Breakthrough Device Designation’ received by 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 […]