The U.S. Food and Drug Administration (FDA) hit Allendale, NJ-based Stryker’s Spine division with a Class I recall for the company’s OASYS Midline Occiput Plate. According to reports, Stryker learned that a post-operative fracture can occur in the pin that connects ...
While machining may not be specified as much as it once was in the medical device industry (outside of the orthopedic realm, that is), it is still very much a necessary component fabrication process for this industry. In fact, machining is being utilized across an array of device sectors, from surgical tools, fixation devices, and dental implants to components for medical pumps, instrumentation, and implantables.
While the use of disposables in healthcare is certainly nothing new, their implementation as instrumentation in orthopedic procedures is. Offering an array of benefits for OEMs and hospitals alike, such as cost savings, improved efficiencies, and enhanced safety, without sacrificing the durability and strength of more traditional instruments, it’s no wonder this trend is occurring.
A surgeon at The Ohio State University Wexner Medical Center is the first in the United States to consult with a distant colleague using live, point-of-view video from the operating room via Google Glass, a head-mounted computer and camera device.
During this procedure at the medical center’s University East facility, Dr. Christopher Kaeding wore the device as he performed ACL surgery on Paula Kobalka, 47, from Westerville, Ohio, who hurt her knee playing softball. As he performed her operation at a facility on the east side of Columbus, Google Glass showed his vantage point via the internet to audiences miles away.
Biomet will go to bat over its M2A-magnum metal-on-metal hip implants after failing to convince an Indiana federal judge that a personal injury lawsuit was preempted by FDA rules. The plaintiff, Leslie Caccia, sued Biomet for a supposedly defective metal-on-metal hip implant in what is now part of a larger multi-district litigation.
BioTime, Inc. today announced that it has received approval from The Spanish Agency of Medicines and Medical Devices (AEMPS) to begin human clinical trials of Renevia™, a unique biomaterial used as a delivery matrix for autologous adipose derived cells to treat the loss of subcutaneous adipose tissue (lipoatrophies) arising from trauma, surgical resection, and congenital defects and disease.
Innovative control technology offers medical professionals and technicians the potential to do much more with diagnostic imaging equipment. “A New Dimension in Diagnostics,” this issue's cover story, looks at intuitive controls for radiological applications.
A first-ever technique using ice slush and minimally invasive robotic surgery to remove a particularly large type of kidney stone has been reported by urologists at Henry Ford Hospital. Dubbed RANL, for robotic anatrophic nephrolithotomy, the technique was devised to remove staghorn calculi...
A new system for visualizing the brain during surgery is helping neurosurgeons more accurately diagnose and treat patients and is even allowing them to perform some procedures that until now have been extremely difficult or even impossible.
A 10-year-old Pennsylvania girl recovering from two double lung transplants is expected to be released from the hospital this week, a spokeswoman for the girl's family said Monday. Tracy Simon said a final decision hasn't been made on exactly when Sarah Murnaghan will leave Children's Hospital of Philadelphia.
Every year, 15 to 20 people in Switzerland lose a hand in an accident. Provided suitable preconditions are met, a hand transplant is the best treatment method, particularly for patients who have lost both hands. The main problem with this treatment is that patients have to be immunosuppressed...
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.
On this episode of The Pulse, brought to you by MDT TV, we are regenerating limbs, building better brain implants, engineering 3D tissue, and measuring consciousness.
Until now, surgeons have had to memorize the precise location of important blood vessels in organs and where tumors could likely be found and need to be removed. A new app for tablet computers developed by Fraunhofer MEVIS in Bremen could support surgeons in the future and help them reduce the rate of complications during operations.
C.R. Bard settled the 2nd bellwether trial over its Avaulta pelvic mesh just before it was supposed to go to trial, a week after losing a $2 million judgment in the 1st trial. Murray Hill, N.J.-based Bard and plaintiff Wanda Queen agreed to settle the case on undisclosed terms...
Many women who have received a transvaginal mesh or sling implant have experienced serious health complications after surgery. The Food and Drug Administration has issued safety warnings concerning the health risks associated with these devices, which have been implanted in thousands of women for the treatment of conditions that result in weakened pelvic floor muscles...
With the launch of the new Olympus WM-P2 series of workstations, Olympus KeyMed has created an ergonomic and efficient platform design, including a flexible arm to support the viewing monitor, in partnership with Southco. It was the company’s new patented positioning technology AV arm series that was to provide the key to the creation of a cutting edge monitor mounting solution.
Scientists at EPFL have developed a new method for making antimicrobial surfaces that can eliminate bacteria under a minute. The technology, now tested in a hospital, shows enormous potential for preventing hospital-acquired infections. One of the biggest problems for hospitals...
neoSurgical Opens U.S. Headquarters and Launches New Medical Device for Minimally Invasive and Laparoscopic Surgery at Minimally Invasive Surgery WeekAugust 20, 2013 9:27 am | by The Associated Press | News | Comments
neoSurgical, an international medical device company focused on advancing safer and simpler solutions for Laparoscopic and Minimally Invasive Surgery (MIS), announces today that it has opened its U.S. headquarters in Chicago and will debut its flagship product neoClose at Minimally Invasive Surgery Week on August 28 in booth #6.
Brain Cancer Lesion Treated with Precisely-Aimed Laser Catheter using ClearPoint Neuro Intervention System in IMRIS iMRIAugust 20, 2013 8:01 am | by The Associated Press | News | Comments
IMRIS Inc. and MRI Interventions, Inc. today announced that a surgical team at Brigham and Women's Hospital (BWH) in Boston, MA, has performed the first laser ablation procedure to combine the use of MRI Interventions' ClearPoint@ Neuro Intervention System as the navigation platform with intraoperative MRI (iMRI) in an IMRIS VISIUS@ Surgical Theatre.
The French manufacturer of the mesh used in Coloplast's embattled Aris transobturator tape system was dismissed from one of the thousands of personal injury lawsuits filed over pelvic mesh systems. Plaintiff Kathy Crowell named Analytical Biosurgical Solutions in the lawsuit she filed after her alleged injury from an Aris implantation.
JenaValve Technology, Inc., a privately-held, venture-backed developer, manufacturer and marketer of transcatheter aortic valve implantation (TAVI) systems for the treatment of aortic valve disease, announced today that it has successfully completed the first two implantations of its second-generation transapical JenaValve TAVI system in Canada.
Abbott said it closed the buyout of OptiMedica Corp. it announced in July, paying $250 million up front with another $150 million on the table if development, regulatory and sales milestones are met. The buyout expands the Chicago-area healthcare giant's Abbott Medical Optics ophthalmology unit by adding femtosecond laser-assisted cataract surgery to its portfolio.
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 ...