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Thursday, March 10, 2011

The new Eovist Liver Lesion Library.

Liver Lesion Library

EOVIST® (gadoxetate disodium) Injection

Liver Lesion Library

Redefining Liver Imaging

The EOVIST Liver Lesion Library provides over 700 images along with detailed case studies documenting the use of EOVIST in hepatocyte phase imaging.
EOVIST Liver Lesion Library

INDICATIONS and IMPORTANT SAFETY INFORMATION

EOVIST® (gadoxetate disodium) Injection

INDICATIONS AND USAGE

EOVIST® (gadoxetate disodium) Injection is a gadolinium-based contrast agent indicated for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease.

Gadavist to be released by Bayer....very soon

On Thursday, February 10, 2011, a U.S. federal trademark registration was filed for GADAVIST. This trademark is owned by Bayer Schering Pharma AG, Berlin 13353. The USPTO has given the GADAVIST trademark serial number of85239263


. The current federal status of this trademark filing is NEW APPLICATION - RECORD INITIALIZED NOT ASSIGNED TO EXAMINER.An advisory committee of the U.S. Food and Drug Administration (FDA) today voted unanimously to recommend approval for Bayer HealthCare Pharmaceuticals' Gadovist 1.0 (gadobutrol), a gadolinium-based contrast agent for contrast-enhanced MRI of the central nervous system.

The panel also voted 15-1 to allow Gadovist to be labeled without a contraindication for nephrogenic systemic fibrosis (NSF) in the population at risk for the debilitating disease. However, they advised that Gadovist should carry the same black box warning label required of other gadolinium-based contrast agents (GBCAs) sold in the U.S.
On the recommendation for approval, James Tatum, MD, a nuclear medicine physician with the Veterans Administration, echoed the consensus of his panel colleagues. "I feel that safety data and the efficacy data is at least as good as the approved agents and possibly better," he commented after the vote.
Clinical data indicate that Gadovist can be classified as one of the lower-risk gadolinium-based contrast agents in terms of NSF risk, according to panel member Donna Roberts, MD, a neuroradiologist at the Medical University of South Carolina in Charleston and at St. Jude Children's Research Hospital in Memphis, TN.









Thursday, March 03, 2011

See the IPAD 2 video here, FDA Approval for radiologists

The US Food and Drug Administration has approved the first diagnostic radiology app for use in viewing medical images to make diagnoses using Apple's iPad and iPhone, a title that won the Apple Design Award for "Best iPhone Healthcare & Fitness Application" in 2008. 

The announcement, made earlier today, gives a green light for Mobile MIM, an iOS app component of secure medical imaging product sold by the Cleveland-based MIM Software.

The FDA said the app "is not intended to replace full workstations and is indicated for use only when there is no access to a workstation," but William Maisel, MD, MPH, the chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health, noted that "this important mobile technology provides physicians with the ability to immediately view images and make diagnoses without having to be back at the workstation or wait for film."

The Mobile MIM app allows radiological images to be securely delivered to mobile doctors using an iPad or iPhone, enabling them to view images and make medical diagnoses "based on computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine technology, such as positron emission tomography (PET)." 

The app "allows the physician to measure distance on the image and image intensity values and display measurement lines, annotations and regions of interest," the report stated. 

A lengthy evaluation 

"In its evaluation, the FDA reviewed performance test results on various portable devices," the agency said. "These tests measured luminance, image quality (resolution), and noise in accordance with international standards and guidelines. The FDA also reviewed results from demonstration studies with qualified radiologists under different lighting conditions. All participants agreed that the device was sufficient for diagnostic image interpretation under the recommended lighting conditions."

MIM Software's chief technology officer Mark Cain stats on the company's website that "establishing a diagnostic protocol for medical imaging is no simple matter for a device like the iPhone or iPad. It is critical to understand the characteristics of the device and to establish methods and tools that are safe and effective, while working within those constraints. There has been a gap in the market for a remote imaging device like this, and now it can be filled."

The app is available in 14 languages and in 34 countries in addition to the US. It is expected to become available in the App Store next week, according to the company's site. 

Will Medicare Pay for the new Revo MRI SureScan Pacing System?

The Centers for Medicare and Medicaid Services on Thursday issued a memorandum saying Medicare still won't pay for MRIs in patients who have pacemakers -- including those with devices deemed MRI-safe.

In the memorandum, CMS officials said the health insurance program will start paying for scans in pacemaker patients who participate in certain clinical trials. But government reviewers didn't have time to pass judgment on the new Medtronic product, which is called Revo and was approved by U.S. Food and Drug Administration earlier this month.
For years, Medicare has had a policy denying payment for MRI exams in pacemaker patients due to safety concerns about how the technologies interact. The memo issued this week came in response to a doctor's request for Medicare to reconsider the policy.

"FDA approved the first pacemaker for use during certain MRI exams on Feb. 8," the CMS officials wrote. "This approval ... was too late for CMS to adequately review the evidence to address coverage for MRI for patients that may obtain this device."
On Friday, Medtronic submitted a formal request for Medicare to reconsider the policy once again, said Bob Thompson, the company's senior director
for reimbursement, economics and health policy. CMS must rule on the request within nine months, although Thompson hopes an answer will come sooner.

"We've asked that they consider granting payment for MRIs for people with pacemakers that have been developed specifically for use in the MRI environment and labeled as such by the FDA," Thompson said.
MRI is a test that uses a powerful magnetic field and computer to produce detailed pictures inside the body to diagnose ailments. The cost of a test depends on the body part being scanned; in 2009, Medicare paid about $500 for an MRI of the lower back.
Some commercial insurers on Friday said they likely would pay for MRI tests on patients with the new heart device.
"We would not deny payment for an MRI done on a patient with an MRI-safe pacemaker," said Dr. Patrick Courneya, a medical director for Bloomington-based HealthPartners.
Greg Bury, a spokesman for Minnetonka-based Medica, said: "We think the MRI-safe pacemakers are a good thing."
Medtronic estimates that some 200,000 pacemaker patients in the U.S. must go without MRI scans each year because of potential problems between the devices and the scanners. Analysts believe the MRI-safe device -- the first such product approved for use in the U.S. -- will help Medtronic gain customers in the $4 billion pacemaker market.
Pacemakers with advanced features often sell for close to $6,500, analysts say. Adding MRI-safe technology to the devices could add between 5 percent and 10 percent to the price tag.

MRI AND THE IPAD 2

The iPad 2's HDMI Adapter Will Work With iPhone 4 And iPod ToucH

ipad hdmi adapter
Image: Apple
AAPL Mar 3 2011, 11:57 AM EST
358.49Change

[ABOVE: Apple's new iPad cover video]
The HDMI adapter for the iPad 2 will work with several other iDevices, giving you the option to pump full 1080p video to your TV.
MacDailyNews found the adapter's description in Apple's online store, which says it is compatible with the iPad 2, iPad, iPhone 4, and iPod Touch 4th Generation.
That's great news for anyone who doesn't plan on getting an iPad 2. The adapter isn't availble for order yet, but you can buy it from Apple here when the iPad 2 launches on March 11
According to ITWire, the new iPad “will come in 3 versions — one with Wi-Fi only, the next with Wi-Fi, GPS and a 3G/UMTS chip, and the third new version is expected to be one that offers Wi-Fi, GPS, 3G/UMTS and CDMA, thus delivering Verizon compatibility in the iPad without external CDMA/Wi-Fi modems being required.”
In addition to features for viewing and snapping photos, watching movies, playing videogames and reading eBooks, the new iPad, according to Apple, includes the following features:
  • YouTube HD
  • GPS road map
  • half an inch thin, weighing at one and half pounds
  • a 9.7-inch wide IPS display, which provides for increased high definition viewing angles
  • a full capacitive multi-touch system
  • 1 GHz Apple A4 processor chip
  • a flash storage device ranging from either 16 GB to 64 GB
  • a built-in WiFi 802.11n for high-speed wireless Internet
  • a built-in Bluetooth 2.1 that includes EDR for faster data transfer
  • an accelerometer and compass
  • a high-quality speaker and microphone with 30-pin connector
  • a batter life of up to 10 hours
Some featured applications will include:
  • all of the apps already available on the iPhone and iTouch
  • the App Store, allowing users to purchase and download additional apps and services
  • an eBook app called iBooks, which will essentially double the iPad as an eBook reader like the Kindle or Nook
  • iWork, which will give users the convenience to do their work from the tables such as creating spread sheets, word documents, slide presentations as well as e-mail to import/export files
With an application such as the iWork, individuals in the academic, business, corporate, legal, and/or other parts of the professional world will able to use the new iPad to do assignments for their jobs.
This all sounds great — but one might ask, "What of those in the medical world?" Fortunately, there's an app for that too.
Katherine Hobson of the Wall Street Journal reports that the “FDA recently cleared a radiology app for the iPhone and iPad that will let physicians view medical images including MRI, CT and PET scans.”
Although this is meant to serve only as a backup to lack of access to a full medical workstation, it could prove beneficial to various doctors and dentists across the country, streamlining their work much more effectively — to both their benefit and that of their patients.
Overall, if the new iPad lives up to its stated full potential, then it may just come to replace the Swiss army knife as the multi-task gadget that can do almost anything. But don't throw away that knife just yet, as Apple has still to develop a screwdriver and switchblade app.
At least in the realm of mobile digital computer technology, the iPad would seem to blow its competition away.
After explaining a list of four possible scenarios that other companies could pursue, the Mac Observer, an independent online publication, concluded: “Apple’s iPad competitors are s****ed.”
For now Apple has the market cornered with the iPad.
At the moment there is no other company with the recognition, skill, and time-tested quality of Apple that could possibly come close to developing a smart tablet just as good or better. The cost and risks of undertaking such a feat are just too high, and in this day and age of recession, most companies are less likely to spend their money for research and development —– after all, it's never a wise business decision to fix something if it is not broken.

Great MRI book

MRI In Practice


This is a great book if you are studying for the registry!


Front Cover

http://books.google.com/books?id=PZoaJek9u-oC&printsec=frontcover#v=onepage&q&f=false

coolmristuff

MRI Nueroarm Video