Class I Medical Device Recall: Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps - Failure of Priming BolusJune 28, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments
The SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps (SynchroMed Implantable Infusion Pumps) contain and administer prescribed drugs to a specific site inside the patient’s body. Currently, the approved drugs for use with the SynchroMed Infusion Pump are Infumorph, Lioresal, Prialt (Ziconotide), Floxuridine, Methotrexate and Gablofen.
Class I Medical Device Recall: Medtronic Sutureless Connector Intrathecal Catheter Products ? Catheter OcclusionJune 28, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments
The Sutureless Connector Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion, which is the blockage or stoppage of drug flow due to misalignment at the point where the catheter connects to an implantable pump. Medtronic is removing all unused products that were manufactured with the previous design.
In a new study, a “bioadhesive” coating developed at Brown University significantly improved the intestinal absorption into the bloodstream of nanoparticles that someday could carry protein drugs such as insulin. Such a step is necessary for drugs taken by mouth, rather than injected directly into the blood.
Researchers show that, in mice, the pancreas contains cells capable of being converted into insulin-producing β cells, something that can be done at any age. They also demonstrate that all pancreatic β cells can be regenerated several times and that chemically-induced diabetes in mice can thus be “treated” repeatedly.
On this episode of The Pulse, a major step toward an artificial pancreas, detecting disease from just one drop blood, creating mature human cardiac patches from human heart cells, and a smart sock that helps runners improve their technique and prevent injuries.
In June 2013, Medtronic, Inc. (NYSE: MDT) initiated four medical device notifications to customers worldwide about the SynchroMed® Implantable Infusion System. These notifications provide clinicians with information to help identify and manage issues that impact the safe and reliable delivery of therapy using the SynchroMed Implantable Infusion System.
With the 3rd Edition of IEC 60601-1 impacting U.S. design engineers in June, it is critical they are aware of the implications to their medical device designs. For home healthcare devices, there is a collateral standard that will have a specific effect. This article focuses in on powering these products and the items in the standard of significance for that aspect.
Tangent Medical, an innovator in IV therapy products and creator of the NovaCath Integrated IV Catheter System, announced today its commercial product launch and start to clinical evaluations in several healthcare facilities across the U.S. The commercialization of this product is the first significant advancement in the IV catheter market in more than a decade.
Scientists in the US have developed a novel vaccination method that uses tiny gold particles to mimic a virus and carry specific proteins to the body’s specialist immune cells. The technique differs from the traditional approach of using dead or inactive viruses as a vaccine and was demonstrated in the lab using a specific protein that sits on the surface of the respiratory syncytial virus (RSV).
When designing a medical device that is meant to be used directly by patients in their home, the designer has to keep in mind that the environment of a patient’s home is likely going to be dramatically different compared to a medical facility.
Bacterial DNA may integrate into the human genome more readily in tumors than in normal human tissue, scientists have found. The researchers, affiliated with the University of Maryland School of Medicine's Institute for Genome Sciences, analyzed genomic sequencing data available from the Human Genome Project, the 1,000 Genomes Project and The Cancer Genome Atlas.
Medical electronic devices are no longer a trend; they are the reality of today’s healthcare environment. Seemingly, the number of powered medical devices far exceeds their non-powered counterparts. Even devices that had traditionally not been powered, such as the stethoscope, are now either being replaced by more effective electronic devices or being updated with electronics to function more efficiently and, more simply, better.
Doctors are reporting a major step toward an "artificial pancreas," a device that would constantly monitor blood sugar in people with diabetes and automatically supply insulin as needed. A key component of such a system—an insulin pump programmed to shut down if blood-sugar dips too low while people are sleeping—worked as intended in a three-month study of 247 patients.
Animas Corporation announced today further promising results from the second phase of human clinical trials of a first-generation closed-loop insulin delivery system in development. Data investigating the predictive Hypoglycemia-Hyperglycemia Minimizer (HHM) System demonstrated that the system is capable of maintaining safe glucose levels overnight.
The conference program for MEDICA 2013, International Trade Fair with Congress – World Forum for Medicine, is undergoing a full re-launch. The content repositioning for MEDICA 2013 (to be held from November 20 – 23, 2103 in Düsseldorf, Germany) is designed to closely fit the program of the trade fair’s topics relevant to medical equipment users and to expand the international side of the program.
Much like other medical technology, implants are adapting to a post-depression economy brimming with new materials, new ideas, and ambitious plans for the future. The result is a focus on designing safer, more bio-compatible products for local markets.
Mount Sinai researchers will demonstrate new data on diabetes self-management, as well as the role of prostastic acid phosphatase (PAP) in Prostate Cancer (PCa) bone metastases; identify new molecules that can stimulate the thyroid gland; reveal the prevalence of primary aldosteronism (PA) in an urban population; and show how thyroid autoimmunity may be triggered by endoplasmic reticulum (ER) stress.
A new formulation of synthetic, biochemically absorbable polymers is creating opportunities in the medical device and pharmaceutical fields. These “bioabsorbable polymers” are materials designed to dissolve into compounds that the body can safely absorb or eliminate.
When you squeeze something, it gets smaller. Unless you’re at Argonne National Laboratory. At the suburban Chicago laboratory, a group of scientists has seemingly defied the laws of physics and found a way to apply pressure to make a material expand instead of compress/contract.
Researchers from North Carolina State University have developed a method for creating “nano-volcanoes” by shining various colors of light through a nanoscale “crystal ball” made of a synthetic polymer. These nano-volcanoes can store precise amounts of other materials and hold promise for new drug-delivery technologies.
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...
Ingestible medical devices offer a convenient, non-invasive method of delivering therapeutics, enabling diagnostic procedures, or performing imaging tasks. However, ensuring that the sensitive electronics within the device are protected is a challenge. This article will highlight a coating technology that is being used to guarantee such protection is provided.
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.
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.
Suffolk (UK) based Creative Medical Research (CMR) is giving medical device manufacturers the chance to ask questions of 150 EU and US-based Diabetes Nurses through its latest Omnibus Survey. The survey has already attracted a number of the major medical device manufacturers keen to understand the concerns and thoughts of the Healthcare Professionals who focus on Diabetes and use their technologies every day.