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InspireMD Announces Publication of Meta-Analysis Citing Benefits of Next Generation Mesh-Covered Carotid Stent Systems

Neuro Peripheral/Endo by 0 comments

TEL AVIV, Israel, Dec. 18, 2018 (GLOBE NEWSWIRE) — InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today announced the publication of a meta-analysis of four clinical studies involving dual layered and […]

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Innovative Cardiovascular Solutions Raises $8M in Series C Financing

Financial by 0 comments

KALAMAZOO, Mich., Dec. 18, 2018 /PRNewswire/ — Innovative Cardiovascular Solutions, LLC (ICS), a privately-held clinical stage company developing the Emblok™ Embolic Protection System, today announced the completion of a Series C round of financing, raising a total of $8M. Proceeds from this round will support clinical trials in the U.S. and Europe as well as manufacturing […]

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Cardiva Medical Announces FDA Approval of the VASCADE MVP Vascular Closure System for Multi-Site Vessel Closure Following Electrophysiology Procedures

Regulatory Rhythm by 0 comments

SANTA CLARA, Calif.–(BUSINESS WIRE)–Cardiva Medical, Inc., an innovator in the field of vascular closure, today announced that the company has received PMA approval from the U.S. Food and Drug Administration (FDA) for the VASCADE® MVP Venous Vascular Closure System. VASCADE MVP is the first and only vascular closure system designed […]

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Merit Medical Acquires Assets of Vascular Insights, LLC

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SOUTH JORDAN, Utah, Dec. 17, 2018 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, today announced that it has acquired substantially all of the […]

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DalCor Announces Completion of Patient Enrollment in dal-GenE, the First Phase 3 Precision Medicine Cardiovascular Outcomes Trial in Coronary Heart Disease

Coronary/Structural Heart by 0 comments

LONDON and MONTREAL, Dec. 17, 2018 (GLOBE NEWSWIRE) — DalCor today announced the completion of patient enrollment in the dal-GenE study, the first Phase 3 precision medicine cardiovascular  outcomes trial in coronary heart disease. The dal-GenE study is evaluating the efficacy of the CETP inhibitor dalcetrapib to reduce clinical cardiovascular […]

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Hancock Jaffe Receives Approval for First-in-Human VenoValve Study

Peripheral/Endo Regulatory by 0 comments

IRVINE, Calif., Dec. 17, 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 received regulatory approval from INVIMA, the Colombian equivalent of the U.S. Food and Drug Administration, for its first-in-human […]

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Aortica Corp. Announces FDA Approves Medtronic Valiant NAVION™ for Inclusion in Starnes’ Physician-Sponsored IDE

Peripheral/Endo Regulatory by 0 comments

BELLEVUE, Wash.–(BUSINESS WIRE)–Aortica Corporation today announced that FDA has approved a supplement to an ongoing Physician Sponsored IDE study at the University of Washington (UW) sponsored by Principal Investigator & Chief of Vascular Surgery Dr. Benjamin Starnes. The positive decision allows the use of Medtronic’s Valiant NAVION™ stent graft system […]

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WhiteSwell Announces $30 Million Financing for New Therapeutic Approach to Acute Decompensated Heart Failure

Coronary/Structural Heart Financial by 0 comments

GALWAY, Ireland–(BUSINESS WIRE)–WhiteSwell, a company pioneering new ways to treat acute decompensated heart failure, today announced the close of a $30 million series B funding round led by RA Capital Management and an InCube Ventures syndicate, with participation from other investors. Funds from the round will be used to support […]

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Cambridge Cardiologist and Cardiology MIT Fellow to Release the ‘Heartsense monitor’, the First AI-Driven Wearable Heart Monitor That Prevents Heart Disease and Stroke

Rhythm by 0 comments

BOSTON, Dec. 13,  2018 /PRNewswire/ — Cambridge Heartwear, a medical provider of low-cost, next-generation wearable heart monitors that uses artificial intelligence (AI) to diagnose heart rhythm and respiratory problems in real time is announcing the launch of their company and release of their Heartsense monitor in 2019. In the U.S., strokes are among […]

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Endologix Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

Peripheral/Endo by 0 comments

IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq: ELGX) (the “Company”), a developer and marketer of innovative treatments for aortic disorders, announced today the grant of inducement equity awards to three newly hired employees (together, the “Awardees”). The awards were approved by the Company’s Compensation Committee, which is comprised of independent Directors, on December 5, […]

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