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FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

SILVER SPRING, Md., Nov. 13, 2018 /PRNewswire/ — The U.S. Food and Drug Administration has warned StemGenex Biologic Laboratories LLC (StemGenex) of San Diego, Calif; its owner/manager Rita F. Alexander and laboratory and medical director Jenny R. Galloway, M.D. about marketing a purported stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could lead […]

DJO Global Announces Financial Results for Third Quarter 2018

November 13, 2018 SAN DIEGO–(BUSINESS WIRE)–DJO Global, Inc. (“DJO” or the “Company”), a leading global provider of medical technologies designed to get and keep people moving, today announced financial results for its public reporting subsidiary, DJO Finance LLC (“DJOFL”), for the third quarter ended September 29, 2018. On January 1, 2018, DJO adopted Accounting Standards […]

Reduce Revisions Initiative Launched to Promote Best Practices for Total Joint Replacement Surgery

YARDLEY, Penn., Nov. 12, 2018 /PRNewswire/ — Today marked the launch of the Reduce Revisions Initiative (www.reducerevisions.org), a program focused on supporting orthopedic professionals with the goal of measurably improving outcomes of total joint arthroplasty (TJA). Total Joint Arthroplasty can dramatically improve lives by restoring mobility, reducing pain, and promoting a return to normal activities. Most of […]

Integra LifeSciences Appoints Eric Schwartz, Corporate Vice President, General Counsel and Secretary

PLAINSBORO, N.J., Nov. 12, 2018 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced the appointment of Eric Schwartz as corporate vice president, general counsel and secretary. “I am pleased to welcome Eric as our new general counsel and latest member of the executive leadership team,” said Peter Arduini, president and chief executive officer, Integra LifeSciences. […]

EOS imaging to Present Its EOSapps Suite at the French Society of Orthopedic and Traumatological Surgery Congress (SOFCOT)

November 12, 2018 PARIS–(BUSINESS WIRE)–Regulatory News: EOS imaging  (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – PME), a pioneer in 2D/3D orthopedic medical imaging, will present its EOSapps solution with particular focus on hipEOS 3.0 online surgical planning software at the French Society of Orthopedic and Traumatological Surgery (SOFCOT) Congress, being held November 12-15, […]

CartiHeal Performs First Agili-C™ Implant Case on the East Coast

NEW YORK and KFAR SABA, Israel, Nov. 12, 2018 /PRNewswire/ — CartiHeal, developer of Agili-C, a proprietary implant for the treatment of joint surface lesions, announced today the successful enrollment of the first patient in the Agili-C Investigational Device Exemption (IDE) pivotal study on the East Coast. The surgery was performed by site Principal Investigator Eric J. Strauss, MD, an orthopedic […]

Company Profiles in Artificial Disc Market| Key Players: Zimmer Biomet, Stryker, Globus Medical, Orthofix, Medtronic, DePuy Synthes Companies, NuVasive

11-09-2018 / Press release from: Global Market Insights Inc. Cervical artificial disc segment accounted for the largest revenue share of USD 790.1 million in 2017 and is estimated to show significant growth over the forecast period. Cervical disc replacement is a motion preserving surgery and offers benefits over motion creating surgical fusion procedures. According to a clinical […]

TransEnterix, Inc. Reports Operating and Financial Results for the Third Quarter 2018

November 08, 2018 RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced its operating and financial results for the third quarter 2018. Recent Highlights Total revenue of $5.4 million, including the sale of four […]

InVivo Therapeutics Reports 2018 Third Quarter Financial Results and Provides Business Update

November 08, 2018 CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today provided a business update and reported financial results for the quarter ended September 30, 2018. Richard Toselli, M.D., President and Chief Executive Officer of InVivo, commented, “In the third quarter, we continued to focus efforts on and advance toward our top priority of initiating patient […]

Vericel Reports Record Third Quarter Revenues of $22.5 Million and Raises Full Year 2018 Revenue Guidance

CAMBRIDGE, Mass., Nov. 06, 2018 (GLOBE NEWSWIRE) — Vericel Corporation (NASDAQ:VCEL), a leader in advanced cell therapies for the sports medicine and severe burn care markets, today reported financial results and business highlights for the third quarter ended September 30, 2018 and raised its full year 2018 revenue guidance. Third Quarter 2018 Financial Highlights Total […]

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