Posted in Regulatory and Compliance by MDDI staff on November 21, 2016 The FDA has released a final guidance on Medical Device Reporting for Manufacturers. This follows the corresponding draft guidance of July 2013 and replaces the guidance of March 1977, which is no longer available on FDA’s website. That guidance was ambiguous with regard to […]
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By Nathan Hurst, November 22, 2016 Injury is a sad fact of military service, especially in wartime. According to a study performed by scientists at the Uniformed Services University of the Health Sciences, by far the most frequent is soft tissue injuries to skin, fat and muscle. Of these, muscle damage is particularly difficult to […]
NOVEMBER 22, 2016 BY BRAD PERRIELLO Medtronic (NYSE:MDT) shares dropped in pre-market trading today after the world’s largest medical device company missed Wall Street’s expectations with its fiscal 2nd-quarter sales and lowered its outlook for the rest of the year. Fridley, Minn.-based Medtronic posted profits of $1.12 billion, or 80¢ per share, on sales of […]
All prosthetic implants are subject to some degree of wear and corrosion in the body. Wear is a mechanical process resulting from changes in load distribution and micro-motion, while corrosion is an electrochemical process of metal degradation. Certain types of corrosion, such as fretting, occur when chemical and mechanical factors, including crevice and abrasive wear, […]
By Sheila Kaplan – Published November 22, 2016 WASHINGTON — Has President-elect Donald Trump put a bull’s-eye on the Food and Drug Administration? It’s been less than a year since Robert Califf was sworn in as the Food and Drug Administration’s chief, but already the agency is facing post-election upheaval. Public health advocates are bracing for […]
MELBOURNE, FL–(Marketwired – Nov 22, 2016) – First Choice Healthcare Solutions, Inc.(OTCQB: FCHS) (“FCHS,” “First Choice” or the “Company”), one of the nation’s only non-physician-owned, publicly traded healthcare services companies focused on the delivery of total musculoskeletal solutions with an emphasis on Orthopaedics, including spine care and treatment, today issued formal financial guidance of $40-$45 […]
By GlobeNewswire, November 21, 2016 SPINEWAY, a company specialising in implants and surgical instruments for the treatment of vertebral (spinal) problems, is proud to announce that the Chinese company TINAVI Medical Technologies has joined its capital, following a €1.4 million increase in capital. Following approval by the General Meeting on 4 November, Spineway increased its […]
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