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FDA reconsiders training requirements for painkillers

The Food and Drug Administration is reconsidering whether doctors who prescribe painkillers like OxyContin should be required to take safety training courses, according to federal documents released Friday. A panel of FDA advisers meets next week to review risk-management plans put in place nearly four years ago to reduce misuse and abuse of long-acting painkillers, […]

Who’s (partly) to blame for Theranos’ fallout? Silicon Valley tech reporters

By Emily Wasserman   A lot of fingers have been pointed during Theranos’ fall from grace, with most of them directed at the company and its beleaguered front woman Elizabeth Holmes. But now, a new report is placing some of the blame on new shoulders: the Silicon Valley press. Tech reporters idolized Holmes without asking […]

Modern Medical Coatings Bring Versatility, Multiple Functions

by Jamie Hartford on May 3, 2016   The best medical device designs can be stymied by the reaction of the human body. Implantable devices are greeted as foreign bodies, and they resist insertion, fail to remain in place, or trigger blood clots. Coatings on the surface of a device can help overcome these challenges. […]

Medtronic Hires New Chief Financial Officer

By JOANN S. LUBLIN and RACHEL LOUISE ENSIGN   Medtronic PLC has hired Karen L. Parkhill as its new chief financial officer, recruiting her from the same role at Comerica Inc. Medtronic said Wednesday that Ms. Parkhill would fill the CFO post, after The Wall Street Journal reported Tuesday that Ms. Parkhill had been hired away. She […]

Late-Breaking Study Provides Evidence to Support Beneficial Seven-Year Clinical Outcomes and Patient Satisfaction for 2-Level Prestige LP(TM) Cervical Disc Patients

DUBLIN and CHICAGO – May 3, 2016 – Medtronic plc (NYSE: MDT) today announced results of seven-year follow-up data demonstrating favorable clinical outcomes and patient satisfaction for the 2-level Prestige LP(TM) Cervical Disc compared to 2-level anterior cervical discectomy and fusion (ACDF). The Prestige LP Disc – currently indicated for single-level cervical disc disease causing […]

First Ray Receives FDA 510(k) Clearance for Stealth Staple™

LOGAN, Utah, May 3, 2016 /PRNewswire/ — First Ray, a start-up medical device company focused on advanced surgical devices for improving outcomes for orthopaedic extremity procedures, announces that it has received FDA 510(k) clearance for its innovative Stealth Staple™ System. The Stealth Staple™ System, an intraosseous small bone fixation system, represents a significant advancement for the […]

MiMedx Comments on Flawed Osiris Data Review

MARIETTA, Ga., May 3, 2016 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, responded today to highlight the substantive deficiencies and serious flaws in a […]

Spinal Simplicity Lands Investor In Nueterra Capital, Advances Opportunity For FDA-Cleared Minuteman Fusion Device

May 03, 2016, 09:00 ET from Spinal Simplicity   LEAWOOD, Kan., May 3, 2016 /PRNewswire/ — Spinal Simplicity, a medical device company based in Overland Park, Kan., that develops innovative solutions to treat complex surgical problems, recently announced the closing of a financing round with an investment from private equity and advisory firm Nueterra Capital. After […]

Globus Medical Reports First Quarter 2016 Results

AUDUBON, Pa., May 03, 2016 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal implant manufacturer, today announced its financial results for the first quarter ended March 31, 2016. Worldwide sales increased 5.8% as reported to $139.3 million, or 6.2% on a constant currency basis First quarter net income increased 13.6% to $28.0 million Fully […]

MEDTECH Announces First ROSA Spine Surgery in the United States

MONTPELLIER, France, May 03, 2016 (GLOBE NEWSWIRE) — MEDTECH (Euronext, FR0010892950 – ROSA), a company specialized in designing, developing and marketing innovative surgical assistance robots, today announced the first surgical operation with the ROSA™ Spine in the U.S. was performed at Miami Valley Hospital, a nationally recognized medical facility in Dayton, Ohio. Miami Valley Hospital […]

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