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Titan Spine’s Interbody Device Participates in the Fusion Process

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, LLC announced today that it began limited market release of its ENDOSKELETON® TT system, a new transforaminal lumbar interbody fusion (TLIF) device. The ENDOSKELETON® TT received 510(k) clearance from the U.S. Food and Drug Administration April 15, 2009. This represents the second clearance and product for […]

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Study Results Raise Questions About Vertebroplasty For Patients With Osteoporotic Spinal Compression Fractures

A new study led by Mayo Clinic researchers has found that relief of pain from vertebral compression fractures, as well as improvement in pain-related dysfunction, were similar in patients treated with vertebroplasty and those treated with simulated vertebroplasty without cement injections. The article, “A Randomized Controlled Trial of Vertebroplasty for […]

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Final Medicare Payment Changes Still Benign For Device Cost

Final changes to Medicare hospital-reimbursement levels for the upcoming U.S. fiscal year appear slightly improved compared with a generally benign earlier proposal, suggesting the system won’t create headaches for medical-device companies in the near term. Many pricey devices such as implantable defibrillators and heart stents are sold to hospitals, which […]

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The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for FY 2010

The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), and the Medical Device User Fee Amendments of 2007 (title II of the Food and Drug Administration […]

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Osteotech Reports Second Quarter 2009 Financial Results

EATONTOWN, N.J., July 29 /PRNewswire-FirstCall/ — Osteotech, Inc.(Nasdaq: OSTE), a leader in the emerging field of biologic products forregenerative healing, today reported financial results for the secondquarter and six months ended June 30, 2009. “During the second quarter, we successfully completed several stepsthat have further cleared the pathway toward the […]

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Smith & Nephew Q2 and Half Year Results

Q2 Commentary • Reported trading profit $212 million, up 17% underlying• EPSA increased 10% to 15.4 cents• Orthopaedics continues to be impacted by deferred procedures• Endoscopy achieved strong repair product sales off-set by the weak capital related market• Advanced Wound Management delivered another good sales and profit performance• Trading margin […]

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DJO Incorporated Announces Financial Results for Second Quarter 2009

SAN DIEGO–(BUSINESS WIRE)–DJO Incorporated (“DJO” or the “Company”) a global provider of medical devices that provide solutions for musculoskeletal health, vascular health and pain management, today announced financial results for its operating subsidiary, DJO Finance LLC (“DJOFL”), for the second quarter of 2009, ended June 27, 2009. ReAble Therapeutics, Inc. […]