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DeGen Medical Receives Clearance of CONNECT-L Transverse Connector with F1 MPS(TM) System

FLORENCE, S.C., Aug. 5, 2016 (GLOBE NEWSWIRE) — DeGen Medical has received clearance from the FDA for its CONNECT-L™ Transverse Connector to be used withF1 MPS™ Modular Pedicle Screw System. The F1 MPS™ system is intended to provide immobilization and stabilization of posterior non-cervical spine. The CONNECT-L Transverse Connector is small, low profile, and easy […]

FDA Updates Draft Recommendations on New 510(k) for Device Modifications

By U.S. Food and Drug Administration | August 5, 2016   The U.S. Food and Drug Administration today issued draft updated recommendations to help manufacturers determine when they are required to notify the FDA about modifications made to certain medical devices already on the market, including a separate guidance applicable to software devices. “These draft recommendations are intended to […]

InVivo Therapeutics Q2 meets the street, shares stay steady

August 5, 2016 – By FINK DENSFORD   InVivo Therapeutics (NSDQ:NVIV) shares stayed steady after the company released 2nd quarter earnings that met the street on losses per share. The Cambridge, Mass.-based company reported losses of $5.2 million, or 16¢ per share, for the 3 months ended June 30, 2016. That amounts to a 50% reduction in losses […]

TransEnterix sells first surgical robot in Italy

August 2, 2016 – By John Murawski Morrisville robotics company TransEnterix has sold its first surgical robot, announcing the deal Monday, nearly four months after U.S. regulators rejected the company’s surgical technology in this country. TransEnterix sold its ALF-X robot to Humanitas Hospital in Italy, which had been testing the system for about a year […]

Patients who received Medtronic’s Infuse product to get $8.45 million in settlements

AUGUST 2, 2016 – By Jim Spencer Star Tribune Two patients who were injured by Medtronic’s controversial Infuse bone graft product will receive a combined $8.45 million in settlements with the University of California Los Angeles, where a doctor with financial ties to the company used the product on them. Patients Ralph Weiss and Jerome […]

Johnson & Johnson wins 5-year, $60m supply DoD contract

AUGUST 5, 2016 BY FINK DENSFORD   Johnson & Johnson (NYSE:JNJ)’s Health Care Systems won a $60 million 5-year contract deal with the U.S. Department of Defense to supply dental and medical equipment. The money comes from a fixed-price, indefinite-delivery/indefinite-quantity contract with no option periods. The contract was a competitive acquisition, and J&J was 1 […]

Researchers discover two biomarkers that contribute to spinal osteoarthritis

5th August 2016 A research team at the Krembil Research Institute (Toronto, Canada) has discovered a pair of tissue biomarkers that directly contribute to the joint degeneration associated with spinal osteoarthritis. The study, published in the Journal of Clinical Investigation Insight, is the first to show that elevated levels of both of these biomarkers cause […]

Johnson & Johnson Medical Devices Companies Value-Based Solutions Help Health Systems Address Proposed Mandatory CMS Plan for Episode Payment Models

WEST CHESTER, PA – August 3, 2016 – The Johnson & Johnson Medical Devices Companies are helping health systems across the US achieve better outcomes, efficiencies and higher patient satisfaction through its proven DePuy Synthes Geriatric Fracture Program. DePuy Synthes pioneered the Geriatric Fracture Program for the past decade, and now, it has the potential […]

pSivida Corp and Hospital for Special Surgery Innovation Center Announce Opening of IND for Sustained-Release Implant for Severe Knee Osteoarthritis

WATERTOWN, Mass. and NEW YORK, Aug. 01, 2016 (GLOBE NEWSWIRE) — pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products for eye diseases, and Hospital for Special Surgery (HSS), America’s leading specialty hospital devoted to orthopedics and rheumatology, announce the opening of an investigational new drug application (IND) to […]

Orthofix to Present at the Canaccord Genuity 36th Annual Growth Conference

August 4, 2016 LEWISVILLE, Texas–(BUSINESS WIRE)– Orthofix International N.V. (OFIX), a diversified, global medical device company, today announced that President and Chief Executive Officer Brad Mason will present at the Canaccord Genuity 36th Annual Growth Conference on Wednesday, August 10, 2016 at 9:00 a.m. ET in Boston, MA. A live audio webcast will be available […]

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