Approval
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Hospitals
Legislation Streamlines FDA Approval Process for Medical Device Industry
BY MAURY THOMPSON, THE POST-STAR, GLENS FALLS, N.Y. / DECEMBER 28, 2016 (TNS) — The federal Food and Drug Administration…
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Financial
Integra LifeSciences Announces Approval of Two-for-One Stock Split
PLAINSBORO, N.J., Dec. 22, 2016 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (NASDAQ:IART) today announced that its stockholders approved a…
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Hospitals
CartiHeal Announces FDA IDE Approval of Its Agili-C Implant for the Treatment of Joint Surface Lesions
KFAR SABA, Israel, Dec. 20, 2016 /PRNewswire/ — CartiHeal (2009) Ltd., developer of a cell-free, off-the-shelf implant for use in…
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Hospitals
Anika Wins CE Mark Approval For ORTHOVISC®-T To Relieve Pain and Restore Function of Tendons Damaged by Chronic Injury
December 19, 2016 BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc., (NASDAQ: ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based…
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Biologics
MTF Wound Care’s AmnioBand® and AlloPatch® Pliable Receive the American Podiatric Medical Association Seal of Approval
EDISON, N.J., Dec. 14, 2016 /PRNewswire/ – After evaluating each MTF Wound Care allograft in several areas – including safety, quality and…
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Biologics
SpinalCyte, LLC Receives Institutional Review Board Approval for Phase I Clinical Trial
December 13, 2016 HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based tissue engineering technology company focused on regrowth of the spinal disc nucleus…
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Hospitals
St. Jude Medical Receives CE Mark Approval for Full Body MR Conditional Labeling for the Proclaim Elite Spinal Cord Stimulation System
December 08, 2016 ST. PAUL, Minn.–(BUSINESS WIRE)–St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced CE mark…
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Biologics
curasan receives approval for orthopedic product in the strategically important US market
Kleinostheim, 7 December 2016 – curasan AG, a leading specialist for medical products in the field of orthobiologics, has received…
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Xtant Medical Receives Approval of Compliance Plan from NYSE MKT
BELGRADE, Mont., Nov. 01, 2016 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development, manufacturing…
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Biologics
Orthocell Receives Approval for Human Nerve Regeneration Study Using CelGro®
October 17, 2016 PERTH, Australia–(BUSINESS WIRE)–Regenerative medicine company Orthocell has been granted ethics approval for a human study examining the…
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Hospitals
St. Jude Medical Announces FDA Approval of BurstDR Stimulation, a New Superior Spinal Cord Stimulation Option for Patients Suffering from Chronic Pain
October 04, 2016 ST. PAUL, Minn.–(BUSINESS WIRE)–St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced U.S. approval…
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Hospitals
Regentis Receives IDE Approval for Pivotal GelrinC Clinical Trial
Princeton, NJ and Or Akiva, Israel, September 26 — Regentis Biomaterials, a developer of hydrogels for tissue regeneration, announced it…
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Hospitals
VEXIM Announces the Registration of Its Products SpineJack® and Masterflow™ For the Treatment of Vertebral Fractures in Australia
September 06, 2016 TOULOUSE, France–(BUSINESS WIRE)–Regulatory News VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM / PEA‐PME), a medical device company specializing in…
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Hospitals
Flexuspine Receives FDA Conditional Approval to Begin a Feasibility Study of Its FSU (Functional Spinal Unit) Total Spine Arthroplasty System in the United States
PITTSBURGH, April 22 /PRNewswire/ — Flexuspine, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted conditional…
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Hospitals
BONESUPPORT™ Receives FDA Approval to Initiate IDE Clinical Study with CERAMENT™G
Lund, Sweden, 9 August – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone substitute products to treat bone…
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