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.
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.
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, 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 PlatformAugust 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 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.
Could harvesting stem cells for therapy one day be as simple as asking patients for a urine sample? Researchers at Wake Forest Baptist Medical Center's Institute for Regenerative Medicine and colleagues have identified stem cells in urine that can be directed to become multiple cell types.
The collar came from a complete rethinking of existing collars as it sits low on the patient’s neck and offers support along the contours of the neck muscles, making it much easier for patients to carry out everyday tasks such as eating and communicating.
Broken bones and joint replacements may someday heal faster, thanks to an unusual coating for medical implants under development at The Ohio State University. Researchers have found that bone cells grow and reproduce faster on a textured surface than they do on a smooth one—and they grow best when they can cling to a microscopic shag carpet made of tiny metal oxide wires.
DJO Global, Inc., a leading provider of medical device solutions for musculoskeletal health, vascular health and pain management, announced that the first TaperFill™ Total Hip Replacement (THR) was implanted. TaperFill was developed to accommodate a minimally invasive procedure.