Medical devices are any medical items that are neither a drug nor a biological product. In light of their different mechanisms, actions and regulatory requirements, medical device (MD) trail evaluations are much more complicated than drug trails due to their unique clinical practices....
Wright Medical Hip Lawsuit Update: New Video Informs Patients Why Profemur Z Hip Implant Is Allegedly FailingMay 17, 2013 1:41 pm | by The Associated Press | News | Comments
SAN FRANCISCO--(BUSINESS WIRE)--May 17, 2013--Kent Klaudt, an injury lawyer at the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that Lieff Cabraser released today a video on the injuries suffered by hip replacement patients who received the Profemur Z hip...
PITTSBURGH--(BUSINESS WIRE)--May 17, 2013--Blue Belt Technologies, Inc., an innovative medical technology company commercializing robotic solutions for orthopedic surgery, announces an implant partnership with DJO Surgical, a DJO Global Company. Blue Belt’s NavioPFS orthopedic surgical system...
OrthoView Announces the U.S. Launch of a New, Subscription-based, Digital Planning and Templating Solution for Individual Orthopaedic SurgeonsMay 16, 2013 2:01 pm | by PR Newswire | News | Comments
JACKSONVILLE, Florida, May 16, 2013 /PRNewswire/ -- OrthoView PSL will allow individual surgeons in private practice in the U.S. to access the widely-used OrthoView digital templating software via the Cloud and requires just a PC and Internet connection to get started. OrthoView, the...
Legal-Bay LLC, the Lawsuit Settlement Funding Company, has issued an update on two major hip implant litigations in the mass tort market. And the results are completely different. Legal-Bay believes the Stryker hip litigation on the ABG II and the Rejuvenate which have been already recalled by the company will see a smoother road for plaintiffs looking for a settlement in the not so distant future.
At an event held at Hospital for Special Surgery, GE Healthcare introduced MAVRIC SL, a novel magnetic resonance imaging technique designed to address the growing clinical need to more accurately image soft tissue and bone in patients with MR Conditional-labeled implants, such as joint replacements and other instrumentation.
Knees can perform extraordinary tasks, but when all the activity they encounter takes too great a toll over time, total knee replacement surgery may be advisable. Product developers and manufacturers have to create total knee replacement implants that will perform as long as possible. Realistic simulation with finite element analysis software has now become vital to that process.
On average, implantable devices account for 30 percent of total hospital supply spend, and make up 50 to 80 percent of the total cost for some procedures. Despite these large numbers, processes around managing and tracking these devices are rife with inefficiencies and revenue leakage.
Paula Spurlock was experiencing intense itching following hip replacement surgery. It turned out that she was allergic to the hip implant and the bone cement used to keep the implant in place. Now, a new test can help to prevent this type of problem for future patients who require an orthopedic implant.
A growing number of patients learn of allergies to new hips and knees only after surgery is done. Imagine what Paula Spurlock must have been going through. Shortly after having a hip replaced in 2011, the trouble started. "I had horrible itching, really bad migraines and intense pain throughout my body," she said. "I couldn't take it. Every single thing in me itched."
It’s a familiar scenario – a patient receives a medical implant and days later, the body attacks the artificial valve or device, causing complications to an already compromised system. Expensive, state-of-the-art medical devices and surgeries often are thwarted by the body’s natural response to attack something in the tissue that appears foreign.
In new research published online May 13, 2013 in Advanced Materials, researchers from Brigham and Women's Hospital (BWH) are the first to report that synthetic silicate nanoplatelets (also known as layered clay) can induce stem cells to become bone cells without the need of additional bone-inducing factors.
Xiphos™ ALIF, a VESTAKEEP® PEEK-based spinal implant developed by DiFusion Technologies, has received the U.S. Food and Drug Administration’s (FDA) 510(k) approval for use in Interbody Fusion Devices (IBF) devices. “DiFusion Technologies is very excited about the FDA 510(k) approval of the VESTAKEEP® PEEK-based Xiphos™ ALIF spinal implant,” said Derrick Johns, managing director of DiFusion Technologies.
Ceramic injection molded products are increasingly being used in the manufacture of innovative medical components and devices, thanks to the unique range of material and performance attributes. In this article, the material, its key features, and the growing range of applications for which it is suited are highlighted.
It’s no secret that getting a medical device to market can be a lengthy, frustrating process. Facing the new medical device excise tax and lack of clarity from the FDA around regulatory policies, medtech startups are now starting to rethink launching in the U.S.
AUDUBON, Pa.--(BUSINESS WIRE)--May 9, 2013--Globus Medical, Inc. (NYSE: GMED), a leading spinal implant manufacturer, today announced the launch of FORTIFY ® I, an expandable corpectomy spacer with integrated screws for further stability in addition to supplemental fixation. “The FORTIFY ® I...
When Michael Gore stands, it's a triumph of science and engineering. Eleven years ago, Gore was paralyzed from the waist down in a workplace accident, yet he rises from his wheelchair to his full 6-foot-2-inches and walks across the room with help from a lightweight wearable robot.
A University of North Texas professor has filed a patent on a new laser technology he and his research associate developed for cutting and shaping bone that causes minimal damage to the surrounding tissue and bones, could speed up surgery and recovery times, and even lessen the amount of blood lost during operations.
Wireless healthcare is upon us. Each day, it seems more devices and technology are becoming untethered or new capabilities are being added to wireless devices. No longer are the applications of wireless devices limited to patient monitoring, but rather an array of therapies are now available for treating patients at home or even on the go.
Pluristem Carving Out Distinct Niche in Orthopedic Medicine With New Clinical Trials in Rotator Cuff RepairMay 8, 2013 7:03 am | by The Associated Press | News | Comments
Pluristem (NASDAQ: PSTI) recently announced a new Phase I trial to check safety and evaluate effectiveness of its PLX-PAD cells in chronic tendonitis often leading to rotator cuff disorders, common in tennis players and golfers, where there are roughly 200,000 rotator cuff surgeries done each...
The Combat Ready Clamp made history Friday when it received new critical indications from the FDA making it the first device of its kind approved to treat unmanageable amputations and pelvic wounds not addressable with standard limb tourniquets.
Mitek Sports Medicine, a leading orthopaedics sports medicine company, announced the launch of the HEALIX 3.4-mm Suture Anchor, the company's smallest dual-thread suture anchor for rotator cuff repair, and the launch of a new double-loaded minimally invasive partial thickness rotator cuff repair system, as part of its HEALIX TRANSTEND Implant System.
Maxim Surgical, a new designer and manufacturer of spinal implants, has received 510(k) clearance from the FDA for its new MaxFuse-C cervical interbody fusion system made of Zeniva polyetheretherketone rods from Solvay Specialty Polymers.
Unique energy-based surgical devices afford broad clinical use in the cutting, coagulation, and ablation of tissues using a high velocity jet of thermal plasma, and the PlasmaJet surgical system is one example of this medical device evolution. Plasma is formed when sufficient energy is added to remove outer electrons from a gas to form ions.
Double-amputee Jason Koger used to fly hundreds of miles to visit a clinician when he wanted to adjust the grips on his bionic hands. Now, he's got an app. Koger came to Philadelphia this week to demonstrate the i-limb ultra revolution, a prosthetic developed by the British firm Touch Bionics....