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....
A team of researchers led by a Boston University Biomedical Engineer has developed a new joint lubricant that could bring longer lasting relief to millions of osteoarthritis sufferers. The new synthetic polymer supplements synovial fluid, the natural lubricant in joints, and works better than comparable treatments currently available.
A prototype lab is tasked with inventing solutions to design challenges presented to them by surgeons with medical device ideas. Utilizing a fused-deposition modeling machine and design software, engineers are able to create physical prototypes of medical devices that are able to be put through functional testing.
The tail of a seahorse can be compressed to about half its size before permanent damage occurs, engineers at the University of California, San Diego, have found. The tail’s exceptional flexibility is due to its structure, made up of bony, armored plates, which slide past each other.
The tail of a seahorse can be compressed to about half its size before permanent damage occurs, engineers at the University of California, San Diego, have found. The tail’s flexibility is due to its structure, made up of bony, armored plates, which slide past each other. Researchers are hoping to use a similar structure to create a flexible robotic arm equipped with muscles made out of polymer, which could be used in medical devices.
Study Demonstrates Significant Pain Reduction with DFINE Star Tumor Ablation System in Spinal MetastasesMay 1, 2013 4:40 pm | by DFINE, Inc. | News | Comments
DFINE, Inc., the developer of minimally invasive radiofrequency (RF) targeted therapies for the treatment of vertebral pathologies, released study results highlighting the clinical benefits of advanced Targeted-Radiofrequency Ablation™ (t-RFA) therapy for the management of patients experiencing painful spinal lesions.
This article offers the personal perspective of an industrial designer in his quest to utilize advanced prototyping technology to enable the fabrication of custom orthopedic prosthetics that not only offered the standard function required of such a device, but also one that reflected the personality and style of its owner.
The newly reformatted MD&M East four day conference running alongside the tradeshow, covers everything you need to know from concept development to supplier management, giving you the essential updates to successfully management every step in the product development efficiently and cost effectively.
Wenzel Spine, a medical device company focused on providing minimally invasive, stand-alone alternatives to traditional spinal fusion, today announced the launch of the VariLift-C Stand-Alone Zero-Profile Expandable Cervical Interbody Fusion Device.
Thomas Edison's spirit for discovery is alive and well at Orthocare Innovations, which the Edison Awards has recognized with its top award in the Science and Medicine–Assistive Device category. Orthocare won the top award for its Magellan microprocessor foot ankle system prosthetic device against tough competition, finishing ahead of products in the category from companies including Medtronic.
Going Under the Knife—Millions of Americans will have surgery this year. Whether it’s the result of an emergency, an exploratory procedure, or even elective, some surgical procedures are more common depending on your age. An infographic by the team at Top Surgeries Graphic - CompHealth.
athenahealth, Inc., a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, in partnership with MIT's H@cking Medicine, invites the health care, technology and scientific communities to participate in a Hack-a-Thon on May 4 and 5 at athenahealth's headquarters in Watertown, Mass.
Spine Wave Announces U.S. FDA's 510K Clearance of the StaXx(R) IB System, an Intervertebral Body Fusion DeviceApril 29, 2013 8:00 am | by The Associated Press | News | Comments
Spine Wave, Inc. a privately held medical device company committed to the development and delivery of high-quality innovative medical devices for the treatment of spinal disorders, today announced that it has received 510(k) clearance from the United States Food and Drug Administration to...
Amputees are enjoying an improved quality of life with wireless enabled prostheses. The prosthetic sends data to the care-giver to make better informed adjustments, and the patient can even make adjustments from their mobile phone.
Given the number of device applications that involve the transfer of a gas or liquid, it is no wonder pump technology is such a significant part of many healthcare-related products. “Innovation Drives Pump Technology to Meet Today’s Medical Designs” focuses on how today’s medical device demands are being answered by advanced pump technology.