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Biomet units lose $2.7M royalty dispute with spine surgeon

August 27, 2013 9:29 am | by Mass Device | News | Comments

Two Biomet subsidiaries are on the hook for some $2.7 million in royalty payments to a prominent spine surgeon it stopped paying in 2008, after a New Jersey appeals court upheld a lower court's ruling in Dr. Neil Kahanovitz's favor. Kahanovitz, the former president of the North American Spine Society, sued Biomet units Electro-Biology Inc. and EBI LLC...

Hand Transplantation: A Swiss Research Success

August 26, 2013 10:28 am | by University of Bern | News | Comments

Every year, 15 to 20 people in Switzerland lose a hand in an accident. Provided suitable preconditions are met, a hand transplant is the best treatment method, particularly for patients who have lost both hands. The main problem with this treatment is that patients have to be immunosuppressed...

Fed Rejects Medtronic's Preemption Claim In Off-Label Use of Device

August 23, 2013 4:47 pm | by Business Wire | News | Comments

Kent L. Klaudt, lawyer at the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that U.S. District Court Judge G. Murray Snow of the District of Arizona denied in large part Medtronic’s motion to dismiss a personal injury lawsuit brought by Dr. Cristina Ramirez against the company on grounds that the claims are preempted by Federal law.


Individuals and society save on knee replacement surgery, study shows

August 23, 2013 2:45 pm | by Mass Device | News | Comments

The societal and economic savings of knee replacement surgery outweigh its costs nearly 2-fold, according to an American Academy of Orthopaedic Surgeons study. The, study published this week in the peer-reviewed Journal of Bone & Joint Surgery, addresses recent scrutiny of the cost and durability of knee replacement surgery...

Zimmer Receives FDA Clearance For Patient Specific Instruments (PSI) Shoulder

August 23, 2013 10:44 am | by PR Newswire | News | Comments

Zimmer Holdings, Inc., a world leader in musculoskeletal care, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Zimmer® Patient Specific Instruments (PSI) Shoulder system to complement its Trabecular Metal™ Reverse Shoulder system for reverse shoulder arthroplasty (RSA) procedures.

Shareholders pound Orthofix with lawsuits over restated financials

August 21, 2013 3:25 pm | by Mass Device | News | Comments

Shareholders of Orthofix piled a raft of lawsuits on the medical device company, accusing it of failing to warn investors that would have to restate its financial results going back to 2011. The July 29 announcement sent OFIX shares down more than 16% to $22.63 apiece.

Synergy Biomedical Announces Issuance of Key Patent for Improved Bioactive Bone Grafts

August 19, 2013 11:46 am | by Business Wire | News | Comments

Synergy Biomedical, LLC, a developer of novel biomaterial products, announced today that it was issued its first key patent (U.S. Patent 8,506,981) covering the use of optimized bioactive glass spheres for bone repair. “The recently issued patent demonstrates Synergy’s commitment to developing next generation bone graft products,” stated Mark Borden, Ph.D., president and CEO of Synergy.

Home Sensors Enable Seniors to Live Independently

August 19, 2013 10:29 am | by Ann Kellan, Science Nation Producer | News | Comments

People are living longer and they desire to live as independently as possible in their senior years. But, independent lifestyles come with risks, so researchers are developing "smart home" technologies like these to enhance and monitor ... 


CoAlign Innovations, Inc. Announces FDA Clearance of AccuLIF® Expandable Interbody Device Product Line for Lateral Surgical Approaches

August 19, 2013 8:30 am | by Business Wire | News | Comments

CoAlign Innovations, Inc. announced today that its AccuLIF® XL lateral expandable interbody fusion devices have received marketing clearance from the United States Food and Drug Administration. This new product line addresses fusion procedures employing the lateral approach.

Natus Neurology Incorporated Receives 510(k) & Health Canada Clearance And Launches New Electrodiagnostic System In U.S. & Canada

August 14, 2013 2:59 pm | by PR Newswire | News | Comments

Natus Neurology Incorporated, announced today that it has received 510(k) clearance from the FDA and Health Canada clearance for its new electrodiagnostic system, the UltraPro S100 EMG System. The UltraPro S100 is an EMG/Nerve Conduction device for monitoring and testing electrophysiologic and electrodiagnostic information from the human nervous and muscular system.

Soft Tissue Regeneration Issued USA Patent for Breakthrough L-C Ligament® Technology

August 14, 2013 9:13 am | by PR Newswire | News | Comments

Soft Tissue Regeneration, Inc., an early-stage orthopedic device company, announced today that it was issued U.S. Patent 8,486,143, which relates to the L-C Ligament®, a device for soft tissue regeneration of the anterior cruciate ligament (ACL) of the knee.

Anapol Schwartz Now Investigating DePuy Limb Preservation System Recall

August 13, 2013 11:24 am | by The Associated Press | News | Comments

The Anapol Schwartz national law firm is now investigating the Class I recall of the Limb Preservation System (LPS) Lower Extremity Dovetail Intercalary Component issued by DePuy Orthopaedics on July 11, 2013. Patients who have suffered a LPS failure are encouraged to contact the firm...

Carbon Ion Radiotherapy Safe and Effective for Treating Inoperable Spinal Tumors

August 12, 2013 10:22 am | by Wiley | News | Comments

A new analysis has found that a type of radiation therapy called carbon ion radiotherapy can control cancer growth and prolong survival in patients with spinal tumors. Published early online in CANCER, a peer-reviewed journal of the American Cancer Society, the study indicates that the treatment is a promising alternative for patients whose spinal tumors cannot be surgically removed.


The US Spinal Implant Market Will Grow Modestly To Reach $6.6 Billion by 2021

August 12, 2013 8:01 am | by The Associated Press | News | Comments

According to Millennium Research Group, the global authority on medical technology market intelligence, spinal nonfusion volumes will grow rapidly over the forecast period due to an accumulation of positive clinical evidence and the emergence of new segments within this market.

FDA approves LDR's cervical disc replacement device

August 9, 2013 1:29 pm | by Mass Device | News | Comments

Austin, Tex.-based LDR landed its 1st FDA approval for its Mobi-C device, a cervical disc replacement for patients with degenerative disc disease. The privately held company, which was founded in France but is headquartered in Texas, is marketing the product as better alternative to a last-resort procedure called anterior cervical discectomy fusion, which fuses the vertebra to ease painful symptoms of a herniated disk.

Johnson & Johnson can exclude recall evidence in DePuy ASR bellwether lawsuit

August 9, 2013 1:13 pm | by Mass Device | News | Comments

Evidence of the recall of the DePuy ASR metal-on-metal hip implant can be excluded from a bellwether trial over the device, a federal judge ruled last month. Johnson & Johnson's DePuy Orthopaedics division pulled the DePuy ASR device from the market in 2010, prompting thousands of personal injury lawsuits across the country.

Zimmer owes Stryker $210M for willful infringement

August 8, 2013 1:31 pm | by Mass Device | News | Comments

Zimmer is on the hook for more than $210 million in damages owed to rival Stryker, after a federal judge in Michigan tripled a jury's $70 million decision. Kalamazoo, Mich.-based Stryker sued orthopedics rival Zimmer in December 2010, alleging infringement of 3 patents covering wound debridement technology with Zimmer's Pulsavac Plus device.

Conflicting decisions and new tactics in Medtronic Infuse lawsuits

August 8, 2013 1:06 pm | by Mass Device | News | Comments

The battle over Medtronic's Infuse bone-growth protein continues to be a roller-coaster, with judges in 2 states issuing seemingly conflicting rulings about the validity of patient injury lawsuits against the Minnesota medical device giant and its troubled Infuse bone-growth protein.

LDR Receives FDA Approval for the Mobi-C Cervical Disc for One-Level Use

August 8, 2013 11:36 am | by LDR | News | Comments

LDR, a privately held medical device company offering exclusive spinal implant technologies for both non-fusion and fusion applications, today announced that it has received a letter of approval from the U.S. FDA allowing the commercial sale and distribution of the Mobi-C® Cervical Disc, for one-level indications in the United States.

Stryker Interventional Spine Launches Two New Products to Expanding Portfolio

August 7, 2013 12:15 pm | by PRNewswire | News | Comments

Stryker Interventional Spine announced the clearance of 510(k)s for two additional products to its portfolio. Venom RF Cannula and Venom Electrode are designed to provide an effective and minimally invasive treatment for facet joint pain. The launch of the 11g iVAS Balloon System addresses the surgical trend of shifting toward less invasive treatment options.

Hologic's femur fracture test wins FDA clearance

August 6, 2013 9:29 am | by Mass Device | News | Comments

Hologic touted a new FDA clearance for its Single Energy Femur Exam, a test for finding rare, unusual femur fractures that pose a high risk to patients. The diagnostic exam is intended for patients that do not respond to bisphosphonates, drugs prescribed to prevent osteoporosis.

Not only Bone Density, but also Quality of Bone Predicts Fracture Risk

August 5, 2013 12:28 pm | by University of Eastern Finland | News | Comments

In a study carried out at the University of Eastern Finland, bone histomorphometry and infrared spectroscopy revealed abnormal bone properties in children with vertebral fractures and in children after solid organ transplantation. Bone compositional changes in children with vertebral fractures and after different types of organ transplantation have not been reported previously.

ConforMIS Achieves Significant Funding Milestone with $167.7 Million in Series E Financing

August 2, 2013 3:42 pm | by Business Wire | News | Comments

ConforMIS, Inc., a privately held medical device company pioneering patient-specific orthopedic implants, announced today it has expanded its Series E financing to $167.7 million with participation from top-tier Sovereign Wealth Funds, Government Investment Funds and Private Equity Funds in the U.S., Europe, Asia and the Middle East.

FDA Clears Hologic's Single Energy Femur Exam to Visualize Features Associated with Developing Atypical Femur Fractures on a DXA Platform

August 1, 2013 4:07 pm | by PR Newswire | News | Comments

Hologic announced it received U.S. Food and Drug Administration (FDA) clearance for the Company's Single Energy (SE) Femur Exam on a dual energy x-ray absorptiometry (DXA) platform for the assessment of features associated with atypical femur fractures (AFF).

ConforMIS raises $168M Series E round

July 31, 2013 3:22 pm | by Mass Device | News | Comments

ConforMIS closed a Series E round worth $167.7 million, raised from a consortium of 88 unnamed investors, according to regulatory filings. The Bedford, Mass.-based medical device company makes personalized knee implants based on scans detailing patients' physiology, creating customized instruments and implants that are shipped in a sterile package surgeons can open on the operating table.

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