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.
DJO Global has announced the launch of the Empi Phoenix, an electrical stimulator designed to help simplify treatment of muscle atrophy before and after surgery for total knee replacement or ACL repair.
Zimmer settled a lawsuit with a prominent orthopedic surgeon who claimed a right to royalties for his work on some of the medical device company's knee implants, agreeing to dismiss the case with prejudice. Dr. Norman Scott sought to be included in a trio patents along with another physician, Dr. Giles Scuderi.
Australia sounded the alarm on Stryker's Oasys Midline Occipital Plate, sending a warning to patients and surgeons that the spine stabilization device might break after surgery. Stryker's spinal stabilization plate is part of the Oasys spinal surgery system.
As an industry sponsor, Misonix exhibited and demonstrated its innovative BoneScalpel Ultrasonic Bone Cutting System, which is rapidly gaining acceptance with spine surgeons worldwide. Consistent with the scientific theme of the meeting, an abstract titled "Blood Loss Reduced During Surgical Correction of Adolescent Idiopathic Scoliosis (AIS) with an Ultrasonic Bone Scalpel" was presented by Dr. Peter O. Newton in the form of an e-poster.
Digital Angel Corporation, following its recent share exchange with VeriTeQ Acquisition Corporation, announced that VeriTeQ filed a provisional patent with the U.S. Patent and Trademark Office in September 2012 for a microchip that is able to withstand high temperatures in order to make it compatible with the sterilization processes involved in the manufacturing of implantable medical devices.
If you squeeze a normal object in all directions, it shrinks in all directions. But a few strange materials will actually grow in one dimension when compressed. A team of chemists has now discovered a structure that takes this property to a new level, expanding more dramatically under pressure than any other known material. The finding could lead to new kinds of pressure sensors and artificial muscles.
Stryker said an unexpected, $170 million hit related to its recalled Rejuvenate hip implant pushed its 2nd-quarter profits down nearly 35% and lowered its earnings outlook for the rest of the year. The Kalamazoo, Mich.-based medical device company posted profits of $213 million, or 56¢ per share, on sales of $2.21 billion during the 3 months ended June 30, for sales growth of 5.0% but a bottom-line slide of 34.5%.
Integra LifeSciences Holdings Corporation today announced the commercial launch of the Integra(R) Total Foot System 2, which addresses both reconstruction and acute fractures of the forefoot, midfoot and hindfoot. The Total Foot System 2 enhances the current system by offering a wider variety of plates to better meet surgeons' needs.
Scientists in Granada, Spain have patented a new biomaterial that facilitates generating bone tissue from umbilical cord stem cells. The material consists of an activated carbon cloth support for cells that differentiate, giving rise to a product that can promote bone growth.
Wright Medical Group, Inc. Highlights New Innovations at the American Orthopaedic Foot and Ankle Society (AOFAS) Annual Meeting 2013July 17, 2013 4:00 pm | by Business Wire | News | Comments
Wright Medical Group, Inc. today announced the U.S. commercial launch of the ORTHOLOC ® 3Di Ankle Fusion System at the American Orthopaedic Foot and Ankle Society (AOFAS) Annual Meeting 2013 taking place at the Westin Diplomat in Hollywood, Florida from July 17-20, 2013.
Synthetic implant company Cartiva closed a $4.3 million financing round led by venture capital firm New Enterprise Associates. As part of the round, 1 of the VC firm's partners, Dr. Justin Klein, will join Cartiva's board of directors. The Alpharetta, Ga.-based device maker plans to use the funds to support trials for its synthetic cartilage implant for treatment of arthritis in the big toe.
Cell therapies may stop or reverse the pain and disability of degenerative disc disease and the loss of material between vertebrae, according to Duke University scientists. The health conditions affect thousands of Americans.
AlignMed, the innovative developer of wellness wear that has been scientifically proven to reduce pain and improve posture, has received FDA Registration for its line of breakthrough specialty garments. AlignMed products are in an elite category of garments approved by the FDA Registration process as a Class 1 Medical Device.