New Report Establishes Research Guidelines to Evaluate Repeat Medical Imaging - Neiman Institute

WASHINGTON, Feb. 20, 2013 /PRNewswire-USNewswire/ -- It is inaccurate to assert that repeat patient testing is synonymous with excessive and unnecessary health care costs, according to a new report that provides a classification system that can identify useful imaging testing and aid regulators and insurers in developing sensible, effective utilization and payment policies.

The report by the Harvey L. Neiman Health Policy Institute provides guidelines for health policy researchers to evaluate the appropriateness and efficiency of repeat medical imaging tests. One of the report's authors, Neiman Institute CEO and Research Fellow Richard Duszak, M.D., said some health policy influencers and payers have a confusing, ambiguous understanding of what constitutes repeat testing and do not have uniform mechanisms to separate those tests that are valuable and essential from those that have less value.

"This report goes to the heart of what health reform is intended to achieve," said Dr. Duszak. "The goal of health reform is to contain costs without impeding patient access to care. Sometimes, health care delivery and payment policies are shaped by a misconception that repeat testing is, by definition, unnecessary and wasteful. This report clarifies the different types of repeat imaging and provides guidelines that can enable evaluation of which tests bring value to both patients and the health care system."

source: PR Newswire


MRI Interventions Announces Milestone Achievements

MEMPHIS, Tenn., Feb. 15, 2013 (GLOBE NEWSWIRE) -- MRI Interventions, Inc. (OTCBB:MRIC) announced today that the company ended 2012 having achieved the 20th installation of its ClearPoint® Neuro Intervention System. ClearPoint systems are in clinical use with MRI scanners from the three major manufacturers, Siemens, GE Healthcare and Philips Healthcare, as well as the two major interventional MR/OR platforms that are manufactured by IMRIS and Brainlab.

MRI Interventions' innovative ClearPoint system is an integrated platform for performing a wide range of minimally-invasive neurological procedures under direct, real-time MRI guidance. ClearPoint is an integrated system of reusable components, disposable components and intuitive menu-driven software, which provides guidance for the placement and operation of instruments during neurological procedures performed within the MRI environment. Using the ClearPoint system, a surgeon sees and selects a neurological target, aims the ClearPoint SmartFrame® targeting device, and watches in real-time as the surgical instrument is advanced to the target.

As of December 31, 2012, ClearPoint systems have been installed at 20 sites worldwide. This includes 18 hospitals in the United States and two hospitals in Europe. In addition to the growth in its customer base, the company announced another milestone in having sold 200 disposable units of its SmartFrame kits in 2012.

source: MRI Interventions


Medtronic Announces FDA Approval and Launch of Its Advisa MRI Pacemaker System

MINNEAPOLIS – February 13, 2013 – Showcasing its leadership position in pacing technologies, Medtronic, Inc. (NYSE: MDT), today announced the U.S. Food and Drug Administration (FDA) approval and U.S. launch of its Advisa DR MRI™ SureScan® pacing system. The Advisa MRI system is Medtronic’s second-generation MR-Conditional pacemaker and is the first system to combine the most advanced pacing technology with proven MRI access.

MRI is the standard of care in soft tissue imaging, providing information not seen with X-ray, ultrasound or CT scans, and is critical for early detection, diagnosis and treatment. Advisa MRI was specifically tested and approved for use as labeled with MRI scanners in the U.S. Of the 156 patients scanned in the Advisa MRI Clinical Trial, none showed any MRI-related complications. The new system includes an Advisa MRI device and two CapSureFix MRI™ SureScan® leads, which must be used together.

“Your physician can implant a pacemaker with advanced options that will allow for broad access to MRI scanning,” said Dr. J. Rod Gimbel of Cardiology Associates of East Tennessee in Knoxville, Tenn. “MRI is just so very important and traditional pacemakers not FDA approved for MRI scanning often prevent the patient from having an MRI when they need it. With more than 85 percent of pacemaker patients being at least 65 years old and having multiple co morbidities for which MRI may be needed, it’s key that physicians and patients have a pacing system that allows MRI imaging as a diagnostic procedure.”

source: Medtronic


Medical Imaging Drugs Advisory Committee Recommends Approval of Guerbet NDA for Dotarem® (gadoterate meglumine)

VILLEPINTE, France, Feb. 14, 2013 /PRNewswire/ -- Guerbet, the contrast agent specialist for medical imaging, today announced that the Medical Imaging Drugs Advisory Committee to US Food and Drug Administration (FDA) has voted unanimously by votes of 17 to 0 to recommend that FDA approve the New Drug Application (NDA) for Dotarem® (gadoterate meglumine) for adults, and for pediatric use for children two years of age and older. The Committee voted 10 to 6 (with one member abstaining) not to recommend at this time approval of the indication for children under two years of age.

Dotarem® is the only macrocyclic and ionic gadolinium-based contrast agent (GBCA) for the intravenous use with magnetic resonance imaging (MRI) in the brain (intracranial), spine and associated tissues in adults and pediatric patients to detect and visualize areas with disruption of the blood-brain barrier (BBB) and/or abnormal vascularity. The Guerbet NDA recommended dose is 0.1 mmol Gd/kg.

"Guerbet is very pleased with the Advisory Committee's recommendation to approve Dotarem® based on our comprehensive presentation of clinical and post-marketing data," said Yves L'Epine, CEO of Guerbet Group. "If approved by FDA, we believe Dotarem can provide another CNS imaging option for US clinicians. We are disappointed that the recommendation does not include the indication for children under two years of age, but we take the Committee's comments very seriously and will work to address all FDA questions and concerns."

source: PR Newswire


FDA clearance for Planmed Verity® Extremity Scanner

HELSINKI, Feb. 8, 2013 /PRNewswire/ -- Planmed Verity® is designed to find subtle extremity fractures during the first visit to the clinic – the types of fractures that have most commonly been missed when only using 2D radiographs. Planmed Verity Extremity Scanner is a unique solution to the problem; it provides fast 3D imaging at the point of care. It is intended for pre- and postoperative imaging, and it has better resolution and patient adaptability and uses a significantly lower dose of radiation than full-body CTs. Unlike any other 3D imaging device, Planmed Verity also allows for weight-bearing imaging of the extremities.

As a dedicated extremity scanner, Planmed Verity adapts to the patient with anatomy-specific imaging programs, movements, and carbon-fiber positioning trays. Easily adjustable, soft surfaced gantry and motorized positioning help in finding a comfortable position for various examination procedures. The adjustable user interfaces and efficient all-in-one workflow are also designed to maximize the operator's soothing presence for the patient.

"Planmed Verity is the first and only CT system in the world that can image seated, supine and standing patients. We are excited that this innovative, low dose orthopedic imaging system is now available also in the U.S. We are confident that it will be well received," says Vesa Mattila , Vice President of Planmed Oy.

Planmed's products are well known for their exquisite design and user ergonomics. The U.S. subsidiary Planmed USA, Inc. located in Roselle, IL, is responsible for sales, marketing, and tech support for Planmed products in North America.

source: PR Newsire


GE Healthcare Introduces New Cardiac MRI Analysis Software

WAUKESHA, WI –FEBRUARY 4, 2013 – GE Healthcare today announced two new software packages for advanced analysis of cardiovascular magnetic resonance (MR) images: CardiacVX and MR VesselIQ Xpress. Both CardiacVX and MR VesselIQ Xpress were featured in the GE Healthcare booth at the annual meeting of the Society for Cardiac Magnetic Resonance (SCMR) on February 1-2, 2013, in San Francisco, California.

Cardiac MR can provide a wealth of information about the patient’s cardiac condition such as functional parameters, flow, and infarction. However, extracting this information and presenting it in an integrated fashion to the referring physician can be a time-consuming task for the technologist or clinician performing the study. GE Healthcare’s new CardiacVX software delivers fast, intuitive, semi-automatic analysis of key cardiac parameters, allowing the user to create a comprehensive cardiac patient report within a streamlined clinical workflow.

Recently FDA 510(k) cleared, CardiacVX runs on GE Healthcare’s Advantage Workstation (AW), and provides a range of reproducible tools for rapid reviewing and reporting. For example, CardiacVX performs fast left ventricle segmentation and volumetric functional analysis in just two clicks. Additional tools include myocardial infarct evaluation, flow analysis (with Qp/Qs ratio), time-course analysis, iron-overload assessment, patent foramen ovale (PFO) assessment, and one-click customizable reporting macros, all within an intuitive, guided user interface.

source: GE Healthcare


Study Indicates that Abdominal CT Scans Not Always Necessary in Children with Blunt Trauma

A recent study conducted by the UC Davis school of Medicine has identified seven factors to lessen radiation exposure in young victims of abdominal trauma. The study encompassed more than 12,000 children throughout the country in the Pediatric Emergency Care Applied Research Network (PECARN) and will be published in the upcoming issue of the Annals of Emergency Medicine.

The study involved children arriving within the networks emergency departments following blunt trauma to their torsos such as may have been sustained in bicycle accdents, falls, or assaults. A number of clinical factors were studied, and seven were identified as correlating with risk for involving a clinically important injury. Among the seven factors were evidence of trauma on the abdomen or chest (such as seat-belt marks), neurological changes, abdominal pain or tenderness, abnormal breath sounds and vomiting.

It was found that children who presented with none of these factors present had only a 0.1 percent chance of having an abdominal injury that required acute intervention. In the majority of these cases a CT scan would not likely have presented any significant clinical information.

source: UC Davis School of Medicine


Surgical innovation centre conducts study on breast MRI

HAMILTON, Ont. – The Centre for Surgical Invention and Innovation is launching a research project to understand the US radiologist’s perspective on the use of MRI for breast cancer screening, diagnosis, and treatment.

The primary method of screening for breast cancer in the US is mammography and the primary method of treating a cancerous breast lesion is to perform surgical excision with the potential for drug and radiation therapy when an invasive cancer is found.

MRI is used as a secondary screening tool for women with a high-risk for developing breast cancer. It is not commonly used as an imaging modality for women not in the high-risk category.

The Centre for Surgical Invention and Innovation is developing technology to enable the performance of breast biopsy and potentially ablative therapies in the MRI environment. They would like to understand the following:

• General perceptions and attitudes toward breast MRI • Current trends and procedural volumes in MR breast screening and Biopsy • Perspectives on the current clinical and screening pathway for high-risk patients • Attitudes toward MR breast screening and procedures • Current preferred methods for biopsy in the MR environment • Perspectives on reimbursement for these procedures • The role of the clinician in the capital purchase process • Perspectives on the adoption rate (and influencers to the adoption rate) of new technologies in the MR environment • Reactions to a written concept describing a new system to perform breast biopsy and treatment in the MRI environment

source: Canadian Healthcare Technology


Benefits of CT outweigh cancer risks in young adults

OAK BROOK, Ill. – The underlying medical conditions facing young adults who undergo computed tomography (CT) exams represent a significantly greater health risk than that of radiation-induced cancer from CT, according to a new study published online in the journal Radiology.

CT utilization has grown approximately 10 percent annually over the last 15 years in the U.S., raising fears of an increase in radiation-induced cancers. However, discussions of radiation-induced cancer risk often fail to take into account the condition of the patients being imaged, according to Susanna Lee, M.D., Ph.D., chief of women's imaging at Massachusetts General Hospital and assistant professor of radiology at Harvard Medical School in Boston.

"The impetus for our study was the concern that the lay press often focuses on potential harm caused to patients by CT imaging," Dr. Lee said. "Lacking in this discussion is a sense of how sick these patients already are."

To better understand the risks and benefits of CT in young adults, the research team lead by Dr. Lee and researcher Robert L. Zondervan, M.S., analyzed imaging records of patients 18 to 35 years old who underwent chest or abdominopelvic CT exams between 2003 and 2007 at one of three university-affiliated hospitals in Boston. Children and young adults are more susceptible to ionizing radiation and more likely to live for the approximately 10 to 20 years considered necessary to develop a radiation-induced malignancy.

The researchers had access to records from 22,000 patients, including 16,851 chest and 24,112 abdominopelvic CT scans. During the average 5.5-year follow-up period, 7.1 percent of young adults who underwent chest CT and 3.9 percent of those who had abdominopelvic CT died: figures that were much greater than the 0.1 percent long-term risk of death from radiation-induced cancer predicted by statistical models in both groups.

source: Eurekalert


Sophono Alpha 2 Hearing System Meets Standards for MRI Testing

Sophono, Inc.– manufacturer of abutment-free, implantable, bone conduction hearing devices – has met key industry standards, making it possible for people who have the Sophono Alpha 2™ system, and live in Europe and other countries around the world, to receive magnetic resonance imaging (MRI) with the magnetic device intact.

Sophono, Inc., is a Colorado-based medical device manufacturer. The Sophono Alpha 2 is the only abutment-free, implantable, bone-anchored hearing device on the market, treating those with conductive hearing loss, mixed hearing loss and single-sided deafness. Fitted to the patient’s head with the use of small, implantable magnets, the Sophono Alpha 2 eliminates the problems associated with other bone conduction hearing systems. These include drilling a hole in the patient’s skull and installing a very noticeable screw that pokes out through the skin on the side of the head.

The Alpha 2 hearing device from Sophono has earned clearance for use in an MRI field after passing rigorous tests from ASTM International, the globally recognized leader in the development and delivery of international voluntary consensus standards.

source: Sophono


Augmenix Receives FDA Clearance to Market its TraceIT™ Tissue Marker

Augmenix, Inc., an innovative medical technology company focused on utilizing hydrogel technology in the fields of tissue marking and radiation oncology, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its TraceIT Tissue Marker, an absorbable tissue marker visible under CT, MR, cone beam and ultrasound imaging modalities. TraceIT Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. TraceIT hydrogel is intended to mark tissue for at least 3 months after injection.

Radiation oncologists often combine, or fuse, MR and CT images to improve dose planning accuracy. However, most markers do not have equally good visibility on both CT and MR, limiting their usefulness for image fusion. “The excellent dual CT and MR visibility of TraceIT hydrogel will simplify image fusion, allowing for improved soft tissue alignment, resulting in improved radiotherapy plan accuracy and may help with cone beam CT verification during image guided treatment” said Josh Yamada, MD, Radiation Oncologist at Memorial Sloan-Kettering Cancer Center.

TraceIT Tissue Marker is a synthetic hydrogel consisting primarily of water and iodinated cross-linked polyethylene glycol (PEG). Injectable through a fine needle, small hydrogel injections are clearly visible in the lung, breast, prostate and other tissues. The hydrogel remains stable and visible in tissue for three months, long enough for radiotherapy, and then is absorbed and cleared from the body.

source: Augmenix