Author: Heather Maver – December 7th, 2016 The FDA recently launched a portal for individuals to report allegations of regulatory misconduct of a medical device manufacturer or individuals marketing a medical device. An allegation in this manner is any claim that a medical device manufacturer may be operating in a manner that violates the law […]
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SAN JOSE, Calif., Dec. 15, 2016 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that Health Care Service Corporation (HCSC), an independent licensee of the Blue Cross and […]
December 14, 2016 As an update to the Company’s statement published on November 8, 2016 concerning product supply matters, Zimmer Biomet continues to make excellent progress enhancing certain aspects of its supply chain infrastructure as it harmonizes and optimizes its sourcing, manufacturing and quality management systems. The Company has been successfully addressing the previously disclosed […]
CAMBRIDGE, Mass., Dec. 14, 2016 (GLOBE NEWSWIRE) — Vericel Corporation (NASDAQ:VCEL), a leading developer of expanded autologous cell therapies for the treatment of patients with serious diseases and conditions, today announced that the U.S. Food and Drug Administration (FDA) has approved MACI® (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic single […]
WARSAW, Ind., Dec. 13, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the launch of PrimaGen Advanced Allograft, an autograft substitute containing the same bone healing elements as autograft, but without the risks associated with donor site morbidity or harvest site complications. Allograft is human tissue transplanted from […]
By Christina Jewett and Marisa Taylor – December 12, 2016 In picking Tom Price to be secretary of Health and Human Services, Donald Trump has chosen an orthopedic surgeon who in his congressional career, has loyally promoted the interests of the medical profession — its freedom and importantly, its financial interests. A conservative representing Georgia’s 6th District, Price […]
ATLANTA, GA (PRWEB) DECEMBER 12, 2016 Ortho Sport and Spine Physicians is a leading orthopedic and sports medicine practice located in northwest Atlanta and serving patients throughout the greater Atlanta metropolitan area and the southeastern United States. The MRI imaging facility of Ortho Sport and Spine Physicians is pleased to announce their recent accreditation by […]
December 13, 2016 HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based tissue engineering technology company focused on regrowth of the spinal disc nucleus using human dermal fibroblasts, announced today it has received Institutional Review Board approval to begin clinical trials with its dermal fibroblast cell product, CybroCell, in the treatment of degenerative disc disease. SpinalCyte is now approved […]
December 14, 2016 ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical (RTI) (Nasdaq: RTIX), a global surgical implant company, today announced that Robert P. Jordheim, executive vice president and chief financial officer of RTI, has been named interim CEO. He succeeds Brian K. Hutchison, who informed the RTI board of directors last August of his decision to retire from […]
December 14, 2016 DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, today announced it has a new agreement with Galderma for DUROLANE, a single-injection, hyaluronic acid (HA) product used for joint lubrication in the treatment of pain associated with knee osteoarthritis. Financial terms of the transaction were not disclosed. Bioventus plans to file a […]
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