Avinger Receives CE Marking Approval for Pantheris SV, a New Image-Guided Atherectomy Device Designed to Treat Smaller Vessels

REDWOOD CITY, CA / ACCESSWIRE / October 18, 2018 / Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced Conformité Européenne (CE) Marking approval of Pantheris SV (Small Vessel), a product line extension of the Lumivascular atherectomy system. CE Marking allows for distribution […]

Vascular Graft Solutions Honored by Goldman Sachs for Entrepreneurship as Eyal Orion, Its Founder and CEO, is Among 100 Most Intriguing Entrepreneurs at 2018 Builders + Innovators Summit

TEL AVIV, Israel, Oct. 18, 2018 /PRNewswire/ — Goldman Sachs is recognizing Dr. Eyal Orion, founder and CEO of Vascular Graft Solutions as one of the 100 Most Intriguing Entrepreneurs of 2018 at its Builders + Innovators Summit in Santa Barbara, California. Goldman Sachs selected Dr. Orion as one of 100 entrepreneurs from multiple industries to […]

MC3 Cardiopulmonary Announces FDA Clearance of Crescent™ for Veno-Venous Extracorporeal Membrane Oxygenation (ECMO)

DEXTER, Mich., Oct. 18, 2018 /PRNewswire/ — MC3 ( today announced the launch of the Crescent™Jugular Dual Lumen Catheter, the first such device cleared by FDA for ECMO (Extracorporeal membrane oxygenation) in the United States. MC3’s Crescent catheter is placed through the jugular vein and is connected to an ECMO system, which removes […]

Bluegrass Vascular Announces Enrollment Completion Of International Post-Market SAVE Registry With Early Positive Results

SAN ANTONIO, Oct. 15, 2018 /PRNewswire/ — Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today it has successfully completed enrollment of its prospective, multicenter, post-CE Mark, international SAVE (Surfacer® System to Facilitate Access in VEnous Occlusions) Registry. In addition, the company […]

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 […]

Hemostemix Announces Three Additional Sites Enrolled in Phase II Clinical Trial

CALGARY, Alberta, Oct. 09, 2018 (GLOBE NEWSWIRE) — Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX VENTURE: HEM) is pleased to announce that it has received all approvals from three new medical centers to be clinical trial sites for the Company’s Phase II clinical trial for critical limb ischemia (“CLI”).  In […]

Hancock Jaffe Enters into Sponsored Research Agreement for CoreoGraft with World-Renowned Texas Heart Institute

IRVINE, Calif., Oct. 09, 2018 (GLOBE NEWSWIRE) — Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI, HJLIW), a company specializing in medical devices that restore cardiac and vascular health, announced today that it has entered into a Sponsored Research Agreement with Texas Heart Institute for the development of HJLI’s CoreoGraft®, an off […]

Eximo Medical Receives FDA Clearance for B-Laser™ Atherectomy System to Treat Peripheral Artery Disease (Including ISR)

REHOVOT, Israel–(BUSINESS WIRE)–Eximo Medical Ltd. announced today it has received 510(k) clearance from the U. S. Food & Drug Administration (FDA) for its B-Laser™ Atherectomy System for Peripheral Artery Disease (PAD). B-Laser™ is a transformative 355nm wavelength laser technology designed to address unmet clinical needs for treating multiple vascular indications. The specific indication cleared by the FDA is: […]

Intact Vascular Announces Presentation of TOBA II Pivotal Data

WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that data from its Tack Optimized Balloon Angioplasty (TOBA) II pivotal clinical trial will be presented at the 15th Annual VIVA Conference in Las Vegas, NV on November 5-8. The TOBA II trial […]