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Mazor Robotics Receives Order for Three Mazor X Systems from a Leading Mid-Atlantic Health Care Organization

December 22, 2016 CAESAREA, Israel–(BUSINESS WIRE)–Mazor Robotics Ltd. (TASE:MZOR; NASDAQGM:MZOR), a pioneer and a leader in the field of surgical guidance systems, today announced a three-system order for the Mazor X from a first-time customer, a leading mid-Atlantic health care organization which will install the systems at three of its medical centers. “The level of […]

Intrinsic Therapeutics announces the Filing of PMA Application for its Barricaid® Anular Closure Device for Lumbar Discectomy Patients.

BOSTON, Dec. 21, 2016 /PRNewswire/ — Intrinsic Therapeutics, Inc. announced today that the filing of its Pre-Market Approval (PMA) application with the Food & Drug Administration (FDA) for the Barricaid® Anular Closure device is complete.  Barricaid has been shown to improve the outcomes of patients undergoing discectomy for herniated lumbar discs to relieve sciatica pain. “Approximately 1 million […]

Carevature’s Limited Market Launch in US Brings Promise of Less Trauma and Quicker Recovery to Spinal Decompression Surgery Patients

TEL AVIV, Israel, Dec. 20, 2016 /PRNewswire/ — Carevature announced today that its Dreal™ line of products has begun helping surgeons in the US achieve better outcomes in spinal decompression surgeries. Over 400 patients worldwide have been treated in clinical use, with outstanding safety and recovery results. Six centers in Massachusetts, New Hampshire, Connecticut and Texas, are currently taking part in Dreal™’s limited market […]

Safe Orthopaedics Appoints Its Scientific Advisory Board Consisting of Key Opinion Leaders in the Field of Back Surgery

December 21, 2016 ERAGNY-SUR-OISE, France–(BUSINESS WIRE)–Regulatory News: SAFE ORTHOPAEDICS (Paris:SAFOR) (FR0012452746 – SAFOR), a company offering innovative ranges of sterile implants combined with their single-use instruments, announces the appointment of its Scientific Advisory Board (SAB), made up of four renowned European back surgeons. The SAB will provide high-level advisory support and its main tasks will […]

Inaugural NASS Ultrasound and Fluoroscopic Guided Lumbar Procedures Workshop a success in Singapore

16th December 2016 – by Allen Chen, MD, MPH   Continuing its global educational efforts, NASS successfully produced the inaugural Ultrasound and Fluoroscopic Guided Lumbar Procedures Workshop at the Singapore General Hospital on October 29-30 2016. This was the first freestanding NASS workshop, which was held as an independent course prior to the World Congress on Low […]

FDA May Outlast Trump’s Change Agenda

Jim Dickinson, Posted in Regulatory and Compliance by MDDI Staff on December 16, 2016 Emerging like the campaign that preceded it as the most unconventional in history, the incoming Trump Administration has many conservatives clambering aboard his train, expecting big changes—including relief for industries regulated by FDA. For that to come about, much will depend on […]

How the New FDA Guidance on Biocompatibility Affects Medical Device Manufacturers

Audrey Turley and Thor Rollins – Posted in Testing Services by MDDI Staff on December 20, 2016 In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, which addressed “adulterated” products. Adulterated includes the addition of fillers of reduced “quality or strength;” coloring to conceal “damage or inferiority;” formulation with additives “injurious […]

Should Medicare Allow Outpatient Knee Replacement? Doctors Are Deeply Split

By CHRISTINA JEWETT – DEC. 20, 2016 Five years ago, Dr. Ira Kirschenbaum, an orthopedic surgeon in the Bronx who replaces more than 200 knees each year, would have considered it crazy to send a patient home the same day as a knee replacement operation. And yet there he was this year, as the patient, home […]

Stryker to build $130-million corporate campus in Portage, add 105 jobs

By Tom Haroldson | Special to MLive PORTAGE, MI – Stryker Corp. plans to build a $130-million corporate campus on nearly 300 acres in Portage, creating an estimated 105 new jobs over three years. The proposal for Stryker’s medical instruments division involves 485,000 square feet of facilities that will include a customer experience center, functioning […]

Acumed Reaches Agreement Regarding Patent Infringement of Acutrak® Screw

PORTLAND, OREGON (PRWEB) DECEMBER 21, 2016 Acumed is pleased to announce that it has reached a resolution of a patent infringement dispute involving Acumed’s US Patent No. 6,030,162 and the Skeletal Dynamics REDUCT Headless Compression Screws (Acumed LLC v. Skeletal Dynamics LLC, Case No. 3:15-CV-01581, filed in US District Court for the District of Oregon). […]

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