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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...

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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.

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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.

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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.

Stem Cells in Urine Easy To Isolate and Have Potential for Numerous Therapies

July 31, 2013 10:12 am | by Wake Forest Baptist Medical Center | News | Comments

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.

Innovative Collar to End MND Patients’ Neck Distress

July 30, 2013 12:47 pm | by Medilink | News | Comments

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.

Coating May Help Joint Replacements Bond Better with Bone

July 29, 2013 12:32 pm | by Sheikh Akbar, Ohio State University | News | Comments

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 Surgical, a DJO Global Company, Announces the First TaperFill Hip Stem Implanted

July 29, 2013 7:35 am | by Business Wire | News | Comments

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 ‘Stimulates’ Total Knee and ACL Rehabilitation Market

July 26, 2013 1:17 pm | by DJO Global | News | Comments

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 settles lawsuit against surgeon, knee implant inventor

July 26, 2013 1:07 pm | by Mass Device | News | Comments

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.

Stryker pulls spinal devices off the shelves following failure reports

July 23, 2013 2:19 pm | by Mass Device | News | Comments

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.

Misonix Demonstrates BoneScalpelT at International Meeting on Advanced Spine Techniques

July 23, 2013 12:45 pm | by The Associated Press | News | Comments

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.

Temperature-Resistant Microchip to be Used for UDI Compliance for Implantables

July 23, 2013 8:30 am | by Business Wire | News | Comments

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.

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