The FDA put its highest-risk label, Class I, on a recall of Medtronic's (NYSE:MDT) Paradigm insulin infusion pumps, which the medtech giant had warned about earlier this year. Medtronic Canada said last month that it received 2 reports on its Paradigm and Polyfin infusion devices, concerning the over- and under-delivery of insulin therapy.
Critically ill patients present a number of challenges to effective monitoring. Various disease states complicate blood chemistry, compromise perfusion, and cause fluctuating blood pressure levels, heart rates, body temperatures, available oxygen, and pH. Furthermore, the pharmaceuticals used to treat these conditions can skew body chemistry and vital signs, adding to the complexity.
University of Melbourne researchers have developed an efficient system to coat tiny objects, such as bacterial cells, with thin films that assemble themselves which could have important implications for drug delivery as well as biomedical and environmental applications.
As medical systems move from hospitals to homes and onto human bodies, designers need to realize their users are not professionals anymore. These new at-home users do not understand conditions that could impact measurements and the validity of measurements.
A collaboration of biologists, engineers, and material scientists at Brown University has found that jagged edges of graphene can easily pierce cell membranes, allowing graphene to enter the cell and disrupt normal function. Understanding the mechanical forces of nanotoxicity should help engineers design safer materials at the nanoscale.
Patients and Physicians Express Desire to Switch to Transdermal Drug Delivery, Finds Frost & SullivanJuly 11, 2013 7:51 am | by PR Newswire | News | Comments
The $82 billion U.S. drug delivery market is showing no signs of saturation, with major patent expiries, generic competition, tightening Food and Drug Administration (FDA) regulations, and emerging drug delivery systems continuing to provide momentum.
Putting medical devices on the network provides a large number of benefits, such as supporting telemedicine and the easy transfer of test results to electronic medical records (EMR) systems. However, putting these devices on a network also introduces a number of risks.
Using a novel form of immune-genetic therapy, researchers from Yale School of Medicine and the Jagiellonian University College of Medicine in Poland have successfully inhibited a strong immune allergic inflammatory response in the skin of mice. The results suggest the technique could be used to combat a variety of diseases.
Researchers have developed a concept to potentially improve delivery of drugs for cancer treatment using nanoparticles that concentrate and expand in the presence of higher acidity found in tumor cells. The concept involves using nanoparticles made of "weak polybases," compounds that expand when transported into environments mimicking tumor cells, which have a higher acidity than surrounding tissues.
In a study reported in the July 1, 2013 Angewandte Chemie, a group of University of Illinois bioengineers have found a way to strongly adhere hydrogels to hydrophobic silicone substrates, an innovation that provides a valuable new tool for microscale biotechnology.
Milestone Scientific Inc., a leading medical research and development company that designs and patents innovative injection technology, announced today that it has entered into a strategic partnership with Tri-anim Health Services, Inc., the nation’s largest provider of specialty sales and distribution solutions for healthcare, with core competencies in respiratory medicine, anesthesia, NICU, ICU and the OR.
Dr. Jie Zheng and Dr. Robert Weiss are among the most recent to contribute to the growing research of hydrogels, the gelatinous substance that, because of its toughness and plasticity, has several biomedical applications, including cartilage repair, implants for minimally invasive surgery and drug delivery.
CorMedix has announced that it has received CE Mark approval for Neutrolin, a catheter lock solution, for patients with central venous catheters on hemodialysis secondary to advanced chronic kidney disease. The Neutrolin solution includes an anti-coagulant and broad-spectrum antimicrobial combination that is active against common microbes.
Designers should look for a company that not only provides the right silicon, but also development tools, software, and support that are tailored for two main phases of a typical smartphone/tablet-based medical design. The first phase consists of the smartphone interface, and the second phase is the design of the medical device itself.
A research team headed by Dr. Mitsuhiro Ebara, a MANA Scientist of the Biomaterials Unit of the International Center for Materials Nanoarchitectonics, National Institute for Materials Science, developed a new nanofiber mesh which is capable of simultaneously realizing thermotherapy and chemotherapy of tumors.
Dialysis technology makers slid hard today after the Center for Medicare & Medicaid Services proposed a reimbursement decrease of more than 9% for 2014. As of about 2:45 p.m. DaVita Inc. (NYSE:DVA) was down 5.8% to $114.16 and Fresenius (NYSE:FMS) was down 9.8% to $32.03.
To unlock the potential of more frequent therapy, medical devices must move out of the doctor’s office and travel with patients to their homes and offices. But, this great opportunity is not without its challenges. The same patient who stands to reap great benefit from a home medical device may instead endanger themselves by applying the device incorrectly.
Enabling the delivery of a drug directly to the treatment area significantly enhances effectiveness. Today, innovative new devices incorporating drug-loaded fibers into implantable textile structures have the potential to deliver this type of benefit to an array of therapeutic treatments.
As Parker sees it, the three biggest obstacles to [design] success for patient care products, such as oxygen concentrators and ventilators, are portability, battery life, and reliability. To make home care products more portable, Parker has reduced the size of some valves up to 75%.
As more therapies are able to indicate implantable devices for treatment, incorporating drug delivery into them can be a significant additional benefit. Even when drug delivery is the primary function, implantable devices can be preferable. This article reviews some representative applications that device designers can leverage in developing new products for the implantable drug delivery market.
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.