Minnesota medical device giant Medtronic (NYSE:MDT) confirmed today that it recalled certain of its already-troubled Infuse spinal fusion surgery kits after learning of possible contamination in sponges manufactured by Integra Lifesciences.
SpineGuard announced today that it has obtained regulatory clearance from COFEPRIS (the Mexican healthcare regulatory authority) to sell its Cannulated PediGuard® device in Mexico. SpineGuard has previously received clearance for its Classic PediGuard device, and over 50 Mexican spine surgeons have been trained on the technology.
A study by researchers at Hospital for Special Surgery has provided the first evidence that the shape of a person's knee could be a factor in the decision of whether a patient should undergo anterior cruciate ligament reconstruction after an ACL tear.
ArthroCare Corp. (NASDAQ: ARTC), a leader in developing state-of-the-art, minimally invasive surgical products, today announced that it has completed the acquisition of ENTrigue Surgical, Inc., a privately held Delaware corporation (“ENTrigue”), in an all cash transaction.
Dallen Medical Initiates “First-in-Man” Clinical Study of its Compressyn™ Band Sternal Closure DeviceJuly 2, 2013 8:00 am | by Business Wire | News | Comments
Dallen Medical, an emerging medical device company, announced today that the first three patients have been treated using its proprietary Compressyn™ Band sternal closure device. The first Compressyn device used for stabilization and rigid fixation following open heart procedures was performed by Dr. Joseph Wilson of Eisenhower Medical Center.
ZOLL Medical Corporation has purchased the assets of CoAxia, an early revenue stage medical device company that provides catheter-based perfusion augmentation therapies to improve outcomes for patients with cerebral ischemia resulting from vasospasm, following subarachnoid hemorrhage.
Is it possible, that in 2-3 years Brits, Germans, Scandinavians, and Russians will undergo cancer treatment, orthopaedic, or cardiac surgery procedures in Polish medical facilities more often? Treat teeth and get implants in dental clinics; take a cure in Polish sanatoriums?
Engineers from Queen Mary, University of London have developed the most precise computer simulation of how red blood cells might travel around the body to help doctors treat people with serious circulatory problems. Understanding how damaged red blood cells might interact with each other or their neighboring cells could be useful in realizing blood flow in patients who are diabetic or have had surgery to address circulation complications.
When a breast tumor is detected, many women opt to have a lumpectomy, which is surgery designed to remove the diseased tissue while preserving the breast. But during this procedure, doctors cannot learn right away whether all of the cancerous tissue has been removed, with no microscopic signs that cancer cells were left behind.
To reduce the need for second surgeries, four Johns Hopkins graduate students have designed a device to allow pathologists to quickly inspect excised breast tissue within 20 minutes, while the patient is still in the operating room. If this inspection indicates that the tumor was not fully removed, additional tissue can then be removed during the same operation.
The antibacterial effects of silver are well established. Now, researchers at Yonsei University in Seoul, Republic of Korea, have developed a technique to coat glass with a layer of silver ions that can prevent growth of pathogenic bacteria including Escherichia coli, Salmonella typhimurium and Campylobacter jejuni. The technology could be used to protect medical equipment.
There have been reports of issues and lawsuits from procedures gone wrong when a robotic surgical system was used. Yes, there have been issues and they do need to be addressed, however, abandoning robotic surgical systems is not the answer. In fact, it would be a complete mistake.
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis. A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.
CryoLife, Inc. (NYSE: CRY), a leading tissue processing and medical device Company focused on cardiac and vascular surgery, announced today that it has received conditional approval of its Investigational Device Exemption (IDE) for PerClot from the United States Food and Drug Administration (FDA).
The firm received complaints of "cuff leak" or "cuff deflation" occurring when the inflation valve cap is inappropriately removed (pulled off, instead of snapped-off sideways). This requires the physician to re-inflate or replace the deflated tube to ensure the continued breathing support of the patient. Use of this recalled product can result in serious adverse health consequences, including death.
A team of NUS researchers from the Departments of Bioengineering and Orthopaedic Surgery has developed a highly realistic three-dimensional (3D) tumour model. As it replicates the conditions in the body, it is able to track the effectiveness and progress of drug therapy.
Shares of Medtronic slipped Tuesday, a day after the medical device maker announced findings from independent reviews of studies of its Infuse bone graft. The Minneapolis company said the reviews, conducted through Yale University, concluded that clinical success rates with its Infuse product were equivalent to more traditional bone graft procedures in which bone is taken from the hip.
For a long time, heat insulation was en vogue – and nearly no one was concerned about poor indoor air quality. And yet excess CO2 hampers concentration. Now, researchers have come up with an intelligent door seal system.
OrthoSensor has announced that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VERASENSE Knee System with limb alignment. VERASENSE is the first intraoperative instrument system to combine quantifiable data on limb alignment, implant position and soft tissue balancing for surgeons during total knee replacement surgery.
Surgical Theater’s Surgical Rehearsal Platform (SRP) provided neurosurgeons the opportunity to rehearse a complicated cerebral case before entering the operating room, saving the surgical team critical seconds on a time-sensitive procedure.
Millions of people each year have polyps successfully removed during colonoscopies. But when a suspicious polyp is bigger than a marble or in a hard-to-reach location, patients are referred for surgery to remove a portion of their colon — even if doctors aren't sure whether the polyp is cancerous or not.
Codman Neuro, part of DePuy Synthes Companies of Johnson & Johnson, has obtained CE marking for REVIVE SE, a next-generation self-expanding clot removal device for use in treating acute ischemic stroke, the company announced today at the Live Interventional Neuroradiology & Neurosurgery Course (LINNC) in Paris.
On this episode of The Pulse, rewired nerves from amputated limbs allow for prosthetic control with existing muscles, a bioengineered blood vessel is transplanted, diabetes is diagnosed through breath analysis alone, and a new technology is paving the way for low-cost electronic devices that work in direct contact with living tissue inside the body.
Two new studies by researchers at Hospital for Special Surgery have shed light on joint replacement outcomes in patients with rheumatoid arthritis (RA). One study overturns the common belief that RA patients have worse outcomes after a total knee replacement (TKR) than patients who undergo the operation for osteoarthritis.
Approval Of Boston Scientific's Watchman Device Will Support Rapid Growth In The Global Heart Defect Closure Device MarketJune 12, 2013 8:00 am | by The Associated Press | News | Comments
According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, the anticipated Food and Drug Administration (FDA) approval of Boston Scientific's WATCHMAN device will drive rapid growth in the market for global heart defect closure devices. ...