FDA Rule Mandating Unique Device Identification for Reusable Medical Devices Creates New Market Opportunity for VeriTeQ in Breast Implant Sizers and Other Reprocessed DevicesSeptember 30, 2013 8:30 am | by Business Wire | News | Comments
Digital Angel Corporation, a provider of implantable medical device identification and radiation dose measurement technologies, following its recent share exchange with VeriTeQ Acquisition Corporation, discussed today a new market opportunity for identifying breast implant sizers, which was created, in part, by the FDA Final Rule for Unique Device Identification, announced on September 20, 2013.
Intersect ENT Announces Positive Results from Pilot Study of Novel In-Office Implant for Chronic Sinusitis PatientsSeptember 30, 2013 8:05 am | by Business Wire | News | Comments
Intersect ENT, Inc., an innovator in treatment solutions for ear, nose and throat clinicians and their patients, today reported findings from a prospective U.S. multi-center pilot study to evaluate the feasibility, safety and efficacy of the company’s newest steroid delivery implant for patients suffering from the debilitating symptoms of chronic sinusitis.
All interested parties are welcome to join in the development of a proposed new ASTM International standard that will provide guidance on how to conduct axial, bending and torsional fatigue testing of stents. The proposed new standard, ASTM WK23330, Guide for in Vitro Axial, Bending and Torsional Durability Testing of Vascular Stents...
MIT’s new Institute for Medical Engineering and Science (IMES) is tackling some of the world’s biggest health challenges through an interdisciplinary approach that will seek new ways to diagnose and treat infectious, neurological and cardiovascular diseases.
Medical devices are increasingly dependent on software, evolving from the use of a simple two-transistor circuit for early artificial cardiac pacemakers to sophisticated modern systems supporting infusion pumps, electrocardiogram analysis, and image-guided surgery.
The Advanced Medical Technology Association (AdvaMed) today released a new study on pricing trends for implantable medical devices that shows average prices have declined significantly for major categories of implantable medical devices from 2007 through 2011.
Ceramics are not known for their flexibility: they tend to crack under stress. But researchers from MIT and Singapore have just found a way around that problem — for very tiny objects, at least. The team has developed a way of making minuscule ceramic objects that are not only flexible, but also have a “memory” for shape...
On this episode of The Pulse, brought to you by MDT TV, we're treating wounds with a self-healing polymer, implanting a cure for sleep apnea, printing objects in 3D for the blind, and monitoring vital signs with a shirt. This episode feature: Scientists have created the world's first self-healing polymer that can repair itself without any intervention, offering potential applications in wound care.
A lawsuit headed to trial in New Mexico accuses a doctor, hospital and an international biomedical firm of teaming up to implant unneeded pacemakers and other devices in patients to boost profits. Tommy and Barbara Sowards are suing for damages after they say the doctor implanted an unneeded...
Minnesota medical device maker EnteroMedics appeared unfazed by the FDA's response to the company's premarket approval application, anticipating no slowdown in the regulatory process for its landmark Maestro weight-loss implant.
The Food and Drug Administration said Monday that it has approved broader use of an innovative artificial heart valve that can be implanted without major surgery, allowing surgeons to insert the implant through multiple pathways. The agency approved revised labeling for Edwards Lifesciences' Sapien heart valve...
FDA Approves Medtronic's Complete 'SE' Vascular Stent for Use in Superficial Femoral and Proximal Popliteal (Leg) ArteriesSeptember 24, 2013 11:42 am | by The Associated Press | News | Comments
Expanding its role in the treatment of peripheral artery disease in the United States, Medtronic, Inc. (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has approved the Complete SE (self-expanding) vascular stent for use in the lower extremities -- specifically, the superficial femoral artery (SFA) and proximal popliteal artery (PPA), which carry blood through the upper legs.
A team from the University of Texas at Arlington has used mathematical modeling to develop a computer simulation they hope will one day improve the treatment of dangerous reactions to medical implants such as stents, catheters and artificial joints.
Pacemakers, insulin pumps, defibrillators and other implantable medical devices often have wireless capabilities that allow emergency workers to monitor patients. But these devices have a potential downside: They can be hacked. Researchers at Rice University have come up with a secure way to dramatically cut the risk that an implanted medical device could be altered remotely without authorization.
Seven out of 9 hospitals and healthcare providers surveyed "strongly" agreed that medical device makers need to step up their cybersecurity and privacy practices, according to a study conducted by the Deloitte Center for Health Solutions.
In the field of medical technology, wireless devices are seeing some of the most broad-reaching growth. This is due mostly in part to the wide range of applications that wireless medicine encompasses. Mobi Health News reports that the top ten areas wireless medicine has directly benefited include: Alzheimer’s, asthma, breast cancer, COPD, depression, diabetes, heart failure, hypertension, obesity, and sleep disorders.
Hospitals in 2011 paid an average of 34% less for drug-eluting stents than they did in 2007, according to a new report. They also paid 27% less for bare metal stents and 26% less for both pacemakers and cardiac resynchronization therapy defibrillators.
A brighter, better, longer-lasting dental implant may soon be on its way to your dentist's office. Dental implants are posts, usually made of titanium, that are surgically placed into the jawbone and topped with artificial teeth. More than dentures or bridges, implants mimic the look and feel of natural teeth.
The medical device and diagnostics market is set to grow at 4.5 percent per year (CAGR) between 2012 and 2018, totalling $455 billion in 2018, according to the newly-released EvaluateMedTech World Preview 2013, Outlook to 2018: The Future of Medtech report from market intelligence firm Evaluate Ltd.
Vascular Dynamics, Inc. Initiates "First in Human" Clinical Study of Its MobiusHDTM Device for the Treatment of Drug Resistant HypertensionSeptember 23, 2013 8:31 am | by The Associated Press | News | Comments
Vascular Dynamics, Inc. (VDI) announced today the first patient has been treated with the MobiusHD device; a catheter-delivered implant designed for the treatment of drug resistant hypertension. Dr. Chandan Devireddy of Emory University School of Medicine treated the first patient in the FDA-approved CALM-FIM_US Study.
Integra LifeSciences Holdings Corporation today announced the first implantation of its Integra Titan Reverse Shoulder System, in the United States. The system, which is used in the treatment of shoulder replacement surgery, was implanted by William Geissler, M.D., Professor of Orthopaedic Surgery at the University of Mississippi Medical Center.
Vital Access today announced the first U.S. commercial implantation of their VWING Vascular Needle Guide, in a patient presenting with cannulation challenges and with difficulties in achieving ideal dialysis access due to the depth and tortuosity of their AV fistula.
Researchers at the University of Leicester and Glenfield Hospital have successfully used a novel “paper-clip” sized vascular coupling device to tackle resistant high blood pressure. The operation was carried out on Monday 16 September at Glenfield Hospital by Professor André Ng, Professor of Cardiac Electrophysiology at the University of Leicester and Consultant Cardiologist at Glenfield Hospital.
The Food and Drug Administration published new rules Friday that require most medical devices sold in the U.S. to carry a unique code, identifying its make, manufacture date and lot number. The codes will be stored in a publicly accessible database to help regulators, doctors and companies monitor safety issues with devices.
The WaveCrest LAA Occluder is an implantable device that seals off the LAA opening so clots cannot escape into the blood stream and cause a stroke. It is a one-time treatment option for patients who would otherwise be on a lifetime regimen of anticoagulation therapy.