Voluven, an intravenous synthetic starch solution, has received FDA approval for use in surgery as a blood volume expander. Blood volume expanders are used to quickly restore some of the blood volume lost during surgery so that remaining red blood cells can continue to deliver oxygen to the body’s tissues. Voluven is manufactured by Fresenius Kabi, a German company.
Merit Medical Systems, Inc. has received FDA approval for its new Sea Dragon torque device. The device is used specifically with hydrophilic guide wires. It was recently released in Europe. The company plans to release the Sea Dragon product in the U.S. in January 2008.
Lumedx has released CardioManager Performance Management System, software that turns complex clinical, operational and financial data into usable information. Among other things, the software will help manage all of the work across the cardiovascular team, as well as facilitating team collaboration and delivering more than 200 standard reports. The new CardioManager product integrates witht he companies CardioStar suite of cardiovascular information and imaging tools.
The debate among digital radiology (DR), computed radiology (CR) and film doesn’t seem to be letting up. How long will film hang on and is it worth the cost to upgrade to the new equipment that is now available? That seems to be the question that everyone is trying to answer in deciding what the next piece of radiographic equipment to purchase.
DOTmed.com is featuring a Sector Report on just these issues, as well as an analysis of the pros and cons of both types of equipment, and a cost summary of the various options.
Zimmer Holdings has received an approval from the Food and Drug Adminstration (FDA) for its mobile bearing knee, NexGen LPS-Flex Mobile Knee. The product is targeted for minimally invasive surgeries and is designed to extend active deep flexion for patients up to 155 degrees. The product is already being marketed in Europe, Australia and Japan.
Biomet Inc.’s orthopedics group has launched two new hip stems for minimally invasive total hip implants. The new products feature shorter stems, which are designed for proximal femoral bone fixation, while preserving more intramedullary bone than traditional length components. The products are called the Taperloc Microplasty Stem and the Balance Microplasty Stem.
Approximately 1,500 patients per year in the U.S. have surgical instruments accidentally left inside of them after surgery. The vast majority of these (approximately 2/3) are sponges. Now, the Loyola University Medical Center is the first center in the midwest to begin using barcodes to tackle this problem.
According to this story from the LA Downtown News Online, regulatory professionals are a hot commodity with the potential to become some of the top leaders at the major drug and medical device companies. USC School of Pharmacy is working to train this new group of medical pros through its regulatory science department. Money graph:
“With drug and medical device companies developing products at record levels, there is an urgent need for regulatory professionals who can carefully navigate the science, research and ethical issues confronting these companies.”
Cardica Inc. has announced that it will webcast a live off-pump coronary artery bypass graft (CABG) procedure. Doctors will perform the beating heart procedure using Cardica’s C-Port(R) xA and C-Port(R) Flex A Distal Anastomosis Systems, which are designed to allow surgeons to automate the attachment of blood vessel grafts, replacing the process of hand-sewing with sutures.
The procedure and live webcast will take place on January 17, 2008 at 3pm EST. The recorded event will be available to watch following the procedure on ORlive.com.
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