Biomet will go to bat over its M2A-magnum metal-on-metal hip implants after failing to convince an Indiana federal judge that a personal injury lawsuit was preempted by FDA rules. The plaintiff, Leslie Caccia, sued Biomet for a supposedly defective metal-on-metal hip implant in what is now part of a larger multi-district litigation.
SpineGuard Receives FDA 510(k) Clearance for Miniaturized and Directional Versions of Its Pediguard® PlatformAugust 28, 2013 11:40 am | by Business Wire | News | Comments
SpineGuard announced today that it has received FDA 510(k) clearance of three new products that complete its PediGuard platform of single-use drilling instruments which secure the pedicle screw pilot hole: Two miniaturized versions of its classic and curved range, and a directional version of its cannulated series.
The FDA cleared a next-generation sternum compression band made by California bone repair company Dallen Medical. The company's Compressyn Band, used for breastbone closure, features a new polymer coating that older lines of the Compressyn products lack.
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. Food and Drug Administration (FDA) allowing the commercial sale and distribution of the Mobi-C Cervical Disc (Mobi-C) for two-level indications...
The BMI works by interpreting brain waves that allow patients to control, with their thoughts, robotic legs and below-elbow amputees to control neuroprosthetic limbs. Contreras-Vidal has partnered with Dr. Robert Grossman at TMHRI on the research project.
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...
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...
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.
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 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 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, 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.
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 ApproachesAugust 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. & CanadaAugust 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, 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.
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...
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.
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.
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.
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 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.
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, 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 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.