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.
The Food and Drug Administration said last Friday it approved a next-generation silicone breast implant from Johnson & Johnson unit Mentor. The company's MemoryShape breast implant uses a cross-linking gel design that the FDA says is firmer than previous implants.
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. ...
RTI Biologics Inc., a leading provider of orthopedic and other biologic implants, announced today its intent to acquire privately held Pioneer® Surgical Technology (Pioneer), headquartered in Marquette, Mich. Pioneer is a leading medical technology company that manufactures and distributes metal and synthetic products in the orthopedics, biologics, spine, trauma and cardiothoracic markets.
The affected products may have excessively high flow rates. As a result, medications could be delivered too quickly from the balloon to the surgical site and cause patient toxicity due to the rapid influx of medication. This can lead to serious illness...
Medical Specialties Distributors, LLC ("MSD"), the nation's leading alternate-site infusion therapy solutions provider, announced today that it has acquired Medical Technology Resources, LLC ("MTR"). Headquartered in Columbus, Ohio, MTR specializes in providing infusion pumps and related products, as well as biomedical and billing services to alternate-site health care providers.
It's a life or death matter: Who gets the next scarce donated organ? In an unprecedented challenge to the nation's transplant system, a federal judge has allowed one dying child — and a day later another — to essentially jump the line in rulings that could have ramifications for thousands of people awaiting new organs.
The use of lasers in the development of medical devices through to their actual usage in the devices themselves has been a steadily growing trend. The capabilities and functionality they offer to both design engineers as well as healthcare professionals is varied and beneficial. This article looks at the advantages lasers offer in the development of medical devices.
Teleflex Incorporated (NYSE: TFX), a leading global provider of medical devices for critical care and surgery, today announced the acquisition of Eon Surgical, Ltd., a late stage development company that has advanced a minimally invasive microlaparoscopy surgical platform technology designed to enhance surgeons’ ability to perform scarless surgery while producing better patient outcomes.
The surgeon who more than two decades ago pioneered deep brain stimulation surgery in the United States to treat people with Parkinson's disease and other movement disorders has now developed a new way to perform the surgery — which allows for more accurate placement of the brain electrodes and likely is safer for patients.
Bernstein Liebhard LLP Announces That a Class Action Has Been Filed Against Intuitive Surgical, Inc.June 5, 2013 1:36 pm | by PR Newswire | News | Comments
Bernstein Liebhard LLP today announced that a class action has been commenced in the United States District Court for the Northern District of California on behalf of all those who purchased shares of Intuitive Surgical, Inc. between October 19, 2011 and April 18, 2013, inclusive.
Obesity surgery worked much better at reducing and even reversing diabetes than medication and lifestyle changes in one of the most rigorous studies of its kind. But the researchers and others warn that possible serious complications need to be considered.
SI-BONE, Inc. Announces Publication of Postmarket Surveillance Safety Data on First 5,319 Patients Treated with iFuse Implant SystemJune 5, 2013 7:00 am | by The Associated Press | News | Comments
SI-BONE, Inc. (San Jose, California), a medical device company that is pioneering the use of a minimally invasive surgical (MIS) device to fuse the sacroiliac (SI) joint, announced today the publication of the iFuse Implant System's@ postmarket surveillance safety data for the first 5,319 patients treated.