Esaote’s New Weight-Bearing MRI Improves Imaging For Patients With Pain

CHICAGO--(BUSINESS WIRE)--For many patients, diagnosing their back, hip, or knee pain is best accomplished by imaging anatomy in a weight-bearing, or standing, position. At the 2013 Annual Meeting of the American Academy of Orthopedic Surgeons in Chicago, Esaote introduces the new G-scan Brio with eXP technology to give physicians a cost-effective tool for performing both traditional and weight-bearing musculoskeletal MRI exams.

G-scan Brio is an open, non-claustrophobic musculoskeletal MRI system designed for cost-effective operation and patient comfort. New eXP technology is a combination of hardware and software that enables faster imaging exams while decreasing power consumption and reducing operating costs.

Traditional MRI systems require the patient to lie down on a bed and be transported into an immovable tube for the exam. With G-scan Brio, a patient will lie down on the bed, and then the bed and open magnet both rotate on a central axis, enabling the patient to be examined in a weight-bearing position. Physicians can now compare weight-bearing and traditional supine studies to make the most accurate diagnosis.

“For many patients, their symptoms worsen when they’re standing or in a weight-bearing position,” said Douglas Smith, MD, founder of Musculoskeletal Imaging Consultants in San Antonio, TX. “Traditional MRI systems scan these patients in a recumbent position, which fails to explain their symptoms. Consequently, many patients don’t receive the proper treatment and suffer needlessly.”

New eXP technology combines powerful hardware platform with advanced software to decrease imaging time by as much as 40%, which is critically important when imaging patients with pain. Since many patients have metal implants, new Metal Artifact Reduction sequences minimize metal artifacts associated with MR imaging.

source: Business Wire

Study: Brain Imaging After Mild Head Injury/Concussion Can Show Lesions

SAN DIEGO, March 12, 2013 /PRNewswire-USNewswire/ -- Brain imaging soon after mild traumatic brain injury (mTBI) or mild concussion can detect tiny lesions that may eventually provide a target for treating people with mTBI, according to a study released today and that will be presented at the American Academy of Neurology's 65th Annual Meeting in San Diego, March 16 to 23, 2013.

Studies of brain tissue once a person has died have shown that different types of lesions are associated with more severe TBI. "Our study suggests that imaging may be used to detect and distinguish between these lesions in a living person with mTBI and this finding has important implications for treatment," said Gunjan Parikh , MD, with the National Institute of Neurological Disorders and Stroke and the University of Maryland R Adams Cowley Shock Trauma Center in Baltimore, MD. Parikh is also a member of the American Academy of Neurology.

The study involved 256 people with an average age of 50 who were admitted to the emergency department at Suburban Hospital in Bethesda and Washington Hospital Center in the District of Columbia after mild head injuries. They underwent magnetic resonance imaging (MRI) brain scans. Of those, 104 had imaging evidence of hemorrhage in the brain (67 percent reported loss of consciousness, and 65 percent reported amnesia, or temporary forgetfulness). People with hemorrhages underwent more detailed brain scans with advanced MRI within an average of 17 hours after the injury.

source: PR Newswire

FluoroPharma Medical Announces Initial Data From Phase II Study for CardioPET(TM) (FCPHA)

MONTCLAIR, NJ -- (MARKETWIRE) -- 02/28/13 -- FluoroPharma Medical, Inc. (OTCBB: FPMI), a company specializing in the development of novel diagnostic imaging products that utilize positron emission tomography (PET) technology for the detection and assessment of disease before clinical manifestation, today released images from the Phase II clinical trial for CardioPET™ (FCPHA) to assess myocardial perfusion and fatty acid uptake in coronary artery disease (CAD) patients.

CardioPET, one of FluoroPharma's first in class PET imaging products, is a perfusion and fatty acid uptake indicator, which is designed to be used as a cardiac imaging agent and may be a more specific alternative to currently available diagnostic tests. Management believes its pharmacokinetic characteristics could be especially valuable in patients who are unable to exercise.

The Phase II trial is an open label study designed to assess the safety and diagnostic performance of CardioPET as compared with myocardial perfusion imaging and angiography, the current gold standard. Trial sites are located in Belgium and results continue to be expected over the next six months.

According to Prof. Roland Hustinx, one of the investigators in the trial and head of nuclear medicine at the University Hospital in Liege, "The images obtained from CardioPET are high quality and agree with previous clinical findings."

source: FluoroPharma

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

Samsung Electronics America Acquires Medical Imaging Company – NeuroLogica

Ridgefield Park, NJ – January 28, 2013 – Samsung Electronics America, Inc., a subsidiary of Samsung Electronics Co. Ltd, today announced its acquisition of NeuroLogica, a leading Computed Tomography (CT) company headquartered in Danvers, Massachusetts. Established in 2004, NeuroLogica develops cutting-edge medical imaging products and is known for its world-class portable CT scanners, such as BodyTom and CereTom. Terms of the deal were not disclosed.

The acquisition of NeuroLogica is another important step in the expansion of Samsung’s medical imaging business. Samsung will continue to strengthen its capabilities and product portfolio to establish itself as a trusted leader in the health and medical equipment industry.

The company plans to leverage its global brand awareness and world-leading technology in consumer electronics, IT and communications with NeuroLogica in order to expand medical imaging business.

Samsung Electronics is committed to its 2020 vision to explore new avenues of growth in the healthcare business by enhancing medical imaging diagnosis, providing innovation to both patients and doctors.

source: Samsung

FDA Approves Amyvid™ (Florbetapir F 18 Injection) for Use in Patients Being Evaluated for Alzheimer's Disease and Other Causes of Cognitive Decline

INDIANAPOLIS, April 6, 2012 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, today announced the U.S. Food and Drug Administration (FDA) approval of Amyvid™, a radioactive diagnostic agent indicated for brain imaging of beta-amyloid plaques in patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive decline.[1] Amyvid binds to amyloid plaques, a hallmark characteristic of Alzheimer's Disease,[2],[3],[4] and is detected using PET scan images of the brain.[1]

A negative Amyvid scan indicates sparse to no amyloid plaques are currently present, which is inconsistent with a neuropathological diagnosis of Alzheimer's Disease and reduces the likelihood that a patient's cognitive impairment is due to Alzheimer's Disease.[2] [5] A positive Amyvid scan indicates moderate to frequent amyloid plaques are present; this amount of amyloid plaque is present in patients with Alzheimer's Disease, but may also be present in patients with other types of neurologic conditions and in older people with normal cognition.[1], [4], [6]

It's important to note that Amyvid is an adjunct to other diagnostic evaluations. A positive Amyvid scan does not establish a diagnosis of Alzheimer's Disease, or other cognitive disorder. Additionally, the safety and effectiveness of Amyvid have not been established for predicting development of dementia or other neurologic condition, or monitoring responses to therapies.[1]

source:PRnewsire

fMRI Technique leads to Mind Reading Speller for those Unable to Speak

Researchers have developed a new MRI based technology that can enable language communication in those completely unable to physically speak. According to an article in Biology Jopurnal of Cell Press, the key to the new technology is the first real time brain scanning speller.

The technology expands on an earlier use of fMRI to assess conciousness in people described as being in an unconcious or vegetative state by introducing the capability of answering simple yes or no questions. Going beyond the earlier version, the new scanning technique uses the entire alphabet as well as blank spaces.

While volunteers performed 27 different mental task with each linked to an alphabetical letter or the space key, blood flow in very precise parts of the brain corresponding to these tasks was measured by fMRI and a deterrmination was made of which character they had chosen.

"The work of Adrian Owen and colleagues led me to wonder whether it might even become possible to use fMRI, mental tasks, and appropriate experimental designs to freely encode thoughts, letter-by-letter, and therewith enable back-and-forth communication in the absence of motor behavior," said Bettina Sorger of Maastricht University in The Netherlands, one of the researchers working on the study.

Study Examines Necessity of Additional Imaging in PET/CT Oncologic Reports

Radiologists and nuclear medicine physicians recommended additional imaging about 30% of the time in oncologic PET/CT reports, with about half of those recommendations being unnecessary, a new study shows.

The study, conducted at Brigham and Women’s Hospital in Boston, included 250 patients. The study found that there were 84 recommendations made for additional imaging. When study reviewers examined the patients’ records, they concluded that 43 of those recommendations were unnecessary, said Atul Shinagare, MD, one of the authors of the study. No adverse patient outcome would have occurred by not recommending additional imaging tests in these 43 cases, said Dr. Shinagare.

The study did not specifically address the motivating factors behind the recommendations for additional imaging, however “we feel that some of the most important factors leading to unnecessary recommendations include reluctance of physicians to accept uncertainty regarding diagnosis, partly driven by medicolegal concerns, combined with a failure to fully consider the patients’ clinical circumstances and the likely cost-effectiveness of additional imaging tests,” said Dr. Shinagare.

The study also found that 70% of the time, referring physicians did not follow through on the radiologists’ recommendation for additional imaging.

source: ARRS

MD Anderson Performs First MRI-Guided Brain Biopsy Using ClearPoint(R) System

MEMPHIS, Tenn., June 5, 2012 (GLOBE NEWSWIRE) -- MRI Interventions, Inc. (OTCBB:MRIC) today announced that the first MRI-guided brain biopsy using the company's ClearPoint® System has been performed at MD Anderson in Houston, Texas by neurosurgeon Dr. Ashwin Viswanathan, working with Dr. Sujit Prabhu. The MRI-guided brain biopsy represents the newest use of the ClearPoint System, which has already been successfully used by neurosurgeons in the United States for the insertion of electrodes and catheters in the brain.

MRI Interventions' ClearPoint System is an integrated system of reusable components, disposable components and intuitive, menu-driven software. It provides guidance for the placement and operation of instruments during neurological procedures performed within the magnetic resonance imaging (MRI) environment. Using the ClearPoint system, a physician sees and selects a neurological target, aims MRI Interventions' targeting device, and watches via MRI as the surgical instrument is advanced to the target. The ClearPoint system is intended to be used as an integral part of procedures, such as biopsies and catheter and electrode insertions, which have traditionally been performed using stereotactic methods, and the system is designed to allow those procedures to be performed in a hospital's existing MRI suite.

"The system worked well," said Dr. Prabhu. "The clear advantage is confirming the position of the needle tip prior to a biopsy and also identifying a safe trajectory to the lesion."

source: MRI Interventions

Breast MRI helps predict chemotherapy's effectiveness

OAK BROOK, Ill. – Magnetic resonance imaging (MRI) provides an indication of a breast tumor's response to pre-surgical chemotherapy significantly earlier than possible through clinical examination, according to a new study published online in the journal Radiology.

Women with breast cancer often undergo chemotherapy prior to surgery. Research has shown that women who receive this treatment, known as neoadjuvant chemotherapy, are more likely to achieve breast conservation than those receiving chemotherapy after surgery.

Clinicians track a patient's response to neoadjuvant chemotherapy through clinical measurements of the tumor's size and location. Contrast-enhanced MRI offers a promising alternative to the clinical approach through its ability to detect blood vessel formation in tumors, known as angiogenesis. Angiogenesis is an earlier and more accurate marker of tumor response.

"MRI was better than the clinical approach for predicting which patients would go on to have complete tumor response," said Nola M. Hylton, Ph.D., professor of radiology and biomedical imaging at the University of California in San Francisco. "It gave us great information on early response to treatment."

For the study, researchers analyzed data from ACRIN 6657, the imaging component of the multicenter Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis (I-SPY TRIAL) breast cancer trial.

They compared MRI and clinical assessment in 216 female patients ranging in age from 26 to 68 years undergoing neoadjuvant chemotherapy for stage II or III breast cancer. MRI sessions were performed before, during and after administration of a chemotherapy regimen. The researchers correlated imaging results with subsequent laboratory analysis of surgical samples.

source: EurekAlert

Hitachi Receives FDA Clearance for Widest Bore 1.5T MR System

CLEVELAND--(BUSINESS WIRE)--Hitachi Medical Systems America, Inc., a leading provider of diagnostic imaging equipment, announced FDA clearance to market its Echelon Oval 1.5T Ultra-Wide MR system.

Echelon Oval sets a new standard for premium wide bore 1.5T MRI with its patient shaped design, resulting in a 74 cm oval bore – the widest in the industry.

“With the evolving changes in health care delivery putting ever more emphasis on patient comfort and satisfaction, Echelon Oval re-shapes expectations for MR imaging,” said Sheldon Schaffer, Vice President and General Manager, MR and CT.

The latest innovation from Hitachi addresses the important aspects of patient accessibility, broad range of clinical capability and optimized workflow. All patients, particularly claustrophobic and anxious ones, will benefit from increased space and visibility. With a diverse suite of advanced imaging techniques including non-contrast MRA, isotropic image acquisition, robust fat suppression and much more, Echelon Oval delivers high diagnostic confidence. In addition, Hitachi’s Workflow Integrated Technology (WIT) suite of efficiency-focused and patient-friendly features, such as an integrated coil system and wide mobile table, optimize the entire imaging process.

“For over two decades Hitachi has lead the way in innovative, reliable MR products that have always put the comfort of the patient first,” Schaffer added. “Echelon Oval joins a storied progression of MR products that deliver state-of-the-art imaging capability, without sacrificing patient comfort.’”

source: Business Wire

Phase 3 Results for GE Healthcare Imaging Agent Flutemetamol Presented at American Academy of Neurology Meeting

NEW ORLEANS, Apr 25, 2012 (BUSINESS WIRE) -- GE Healthcare today announced results from four pooled brain biopsy studies, as well as key results from a brain autopsy study, of the investigational PET amyloid imaging agent, [(18)F]flutemetamol.(1) The data showed that both biopsy and autopsy study images had high sensitivity and specificity, and that strong concordance exists between [(18)F]flutemetamol PET images and Alzheimer's disease-associated beta amyloid brain pathology. The data confirm the potential of [(18)F]flutemetamol as an imaging agent to detect beta amyloid plaque, a pathology associated with Alzheimer's disease (AD), in living patients.

These data are being presented as part of the Emerging Science Program (formerly known as Late-Breaking Science) at the American Academy of Neurology's 64th Annual Meeting in New Orleans, April 21 to April 28, 2012, and support an application for regulatory approval of [(18)F]flutemetamol, which is intended to be filed later this year. [(18)F]flutemetamol is a GE Healthcare PET imaging agent in development for the detection of beta amyloid.

"Currently, the standard for definitively confirming AD is through detection of pathology, including amyloid plaque in the brain during autopsy," said David Wolk, MD, Assistant Professor of Neurology in the Cognitive Neurology Division, Department of Neurology, University of Pennsylvania, presenter and lead investigator for the biopsy study.

GE Healthcare

New BIOTRONIK ICD and CRT-D Series Gives Patients First-Ever Access to MR Scans

BERLIN, Germany, April 12, 2012 — BIOTRONIK, a leading manufacturer of innovative medical technology, announced today the European full market release of the new Lumax 740 ICDs (implantable cardiac defibrillators) and CRT-Ds (cardiac resynchronization therapy defibrillators) in the European market. The Lumax 740 is the world’s first and only ICD and CRT-D series approved for magnetic resonance imaging (MRI)1, now giving ICD and CRT-D patients access to vital MR scans with BIOTRONIK’s innovative ProMRI® technology.

“With its new Lumax 740 series BIOTRONIK is offering physicians and their patients access to state of the art diagnostics and the freedom to select the optimal ICD system for each patient’s indication. The development of the new ProMRI® technology really represents a significant improvement in patient care,” commented Professor Dr. Wilhelm Haverkamp, Charité University Hospital Berlin, Virchow-Clinic Campus, Germany.

Currently patients with standard ICDs are not allowed to have MR scans for safety reasons, yet 50–75% of them will be indicated for an MR scan during the lifetime of their device.2 Worldwide, the population of patients who need an ICD is growing at a rate of about 10–15% annually. At the same time, the need for MR scans is also increasing at a rate of about 10% each year. Approximately 30 million scans were performed in 2006, and in 2010, there were already about 50 million MR scans conducted worldwide.

source: Biotronik

Siemens Announces First Integrated Amyloid Imaging Solution in the U.S. Market for Use in Evaluation of Alzheimer’s Disease and Other Causes of Cognitive Decline

Hoffman Estates, Ill., April 10, 2012 — Siemens Healthcare is the first company worldwide to announce a complete integrated diagnostic imaging solution proposed for the detection of amyloid plaques — one of the necessary pathological features of Alzheimer’s disease1,2,3 — in the living brain. The latest elements of Siemens’ integrated solution came today with the company’s U.S. Food and Drug Administration (FDA) 510(k) application for its syngo®.PET Amyloid Plaque4 proprietary neurology quantification software, as well as the recent FDA approval of Eli Lilly and Company’s Amyvid™ (Florbetapir F 18 Injection), a radioactive diagnostic agent indicated for brain imaging of beta-amyloid plaques in patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.5

Siemens integrated amyloid imaging solution encompasses three unique elements — the new Biograph mCT™ PET•CT scanner, FDA 510(k)-pending syngo.PET Amyloid Plaque neurology quantification software and the manufacturing and distribution of Amyvid. All are examples of Siemens Healthcare’s innovative power and competitiveness, which are two goals of the company’s global initiative, Agenda 2013.

As the largest producer and distributor of Amyvid, PETNET Solutions, Siemens’ network of PET drug manufacturing establishments, will begin supplying Amyvid to imaging centers in limited U.S. markets beginning in June 2012. Complementing the new radioactive diagnostic agent, Siemens pending software could potentially support the quantification of amyloid plaque in the brain. Combined with the company’s family of high-resolution PET imaging scanners, Siemens now announces for the first time an integrated diagnostic tool for patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.

source: Siemens

FDA approves imaging drug Amyvid for PET scanning

The U.S. Food and Drug Administration today approved Amyvid (Florbetapir F 18 Injection) a drug for Positron Emission Tomography (PET) imaging of the brain in adults who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. Cognitive decline refers to a condition where the ability to think and form clear, rational thoughts and decisions has decreased. It can cause an individual to lose touch with reality, oneself, other people, and external events and surroundings.

Amyvid is used to produce PET scans that estimate the brain β-amyloid neuritic plaque density in patients with cognitive impairment. β-amyloid protein is a type of protein that forms in patients with AD and some other cognitive disorders. Neuritic plaques, also called amyloid plaques, are abnormal clumps of brain cells mixed with β-amyloid protein. A negative Amyvid scan indicates few to no neuritic plaques and reduces the likelihood that any cognitive impairment is due to AD. A positive scan indicates moderate to frequent plaques. This amount of β-amyloid plaque can be found in patients with AD, in patients with other types of cognitive impairment, and in older people with normal cognition.

“Many Americans undergo evaluations to try to determine the cause for a decline in cognitive functioning,” says Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “Until now, the brain content of β-amyloid neuritic plaques could only be determined with a brain biopsy or examination of the brain at autopsy. This imaging agent is one tool to help physicians in the assessment of their patients by serving as an adjunct to other diagnostic evaluations.”

Following intravenous injection, Amyvid (a radioactive drug) binds to brain β-amyloid. A radioactive signal is detected with a PET scanner to produce images of the plaque in the brain. A positive Amyvid scan indicates moderate to frequent plaques. However, a positive Amyvid scan does not establish a diagnosis of AD because, although patients with AD always have an increased brain content of plaque, the test also may be positive in patients with other types of neurologic conditions, as well as in older people with normal cognition.


source: FDA

Obese Patients Face Higher Radiation Exposure From CT Scans—But New Technology Can Help

Most medical imaging equipment is not designed with overweight and obese patients in mind. As a result, these individuals can be exposed to higher levels of radiation during routine X-ray and CT scans.

A new study from Rensselaer Polytechnic Institute is the first to calculate exactly how much additional radiation obese patients receive from a CT scan. Research results show the internal organs of obese men receive 62 percent more radiation during a CT scan than those of normal weight men. For obese women, it was an increase of 59 percent.

New technology developed at Rensselaer by nuclear engineering expert X. George Xu could help solve this problem. Xu’s research team created ultra-realistic 3-D computer models of overweight and obese men and women, and used computer simulations to determine how X-rays interact with the different body types. These models, known as “phantoms,” can help empower physicians to configure and optimize CT scanning devices in such a way that minimizes how much radiation a patient receives.

“Radiation exposure is cumulative over a patient’s lifetime. The risk associated with a radiation dose from a single CT scan is relatively small when compared with the clinical benefit of the procedure. But patients are increasingly undergoing multiple CT scans and other radiation-based procedures, which can lead to unnecessary radiation risk. Regretfully, our study shows that obese and overweight patients can be exposed to an even greater level of radiation,” said Xu, head of the Nuclear Engineering Program and a professor in the Department of Mechanical, Aerospace, and Nuclear Engineering (MANE) at Rensselaer.

source: Rensselaer Polytechnic Institute

Siemens’ New Biograph mCT PET•CT System Receives FDA Clearance

Malvern, Pa., February 15, 2012 – Siemens Healthcare has announced that the Food and Drug Administration (FDA) recently cleared the features associated with the new Biograph mCT positron emission tomography/computed tomography (PET•CT) scanner. The new Biograph mCT enables precise measurement of metabolic processes and data quantification, including the assessment of neurological disease and cancerous tissue, as well as cardiac blood flow (perfusion). Technological innovations and intelligent software solutions within the new PET•CT result in accurate, consistent quantitative assessments. With the new Biograph mCT, which was unveiled last November at the 2011 annual meeting of the Radiological Society of North America (RSNA) in Chicago, Siemens offers yet another paradigm in PET•CT, bolstering the company’s innovative power and competitiveness – a goal of its recently announced global initiative, Agenda 2013.

Accuracy and reproducibility in PET quantification enable the physician to more precisely characterize cancer lesions, which permits better staging and monitoring of changes in activity over time for more accurate assessment of treatment response. The ability to measure absolute myocardial blood flow in cardiology allows the physician to more accurately assess multi-vessel disease. In neurology, noninvasive assessment of the brain can potentially improve the diagnosis and management of patients who present with signs of dementia.

source: Siemens Medical

International Medical Imaging Experts Join Efforts to Advance Prostate Cancer Care

BOSTON, Feb. 8, 2012 /PRNewswire via COMTEX/ -- American College of Radiology (ACR), AdMeTech Foundation and European Society of Urogenital Radiology (ESUR) Create Standards for High Quality MRI

ACR, AdMeTech Foundation and ESUR announced today a joint effort to create standards for a high quality prostate MRI and to expedite its transfer of technologies from laboratories to patients. Standards for the Magnetic Resonance Prostate Imaging Reporting and Data System (MR PI-RADS) are modeled after successful efforts in breast cancer care, and are planning to be released in early 2013.

The goal of this international cooperation is to address the central challenge in prostate cancer care recently framed by the U.S. Preventive Services Task Force, American Cancer Society and other groups - improving early detection while reducing unnecessary biopsies and treatment. MR PI-RADS will be based on prostate MRI guidelines developed by ESUR and the work by the AdMeTech Foundation's International Prostate MRI Working Group.

AdMeTech Foundation has been providing international leadership in supporting research, development and testing of high-precision prostate MRI since 1998. AdMeTech's research program has been funded by the Telemedicine and Advanced Technology Research Center, U.S. Army Medical Research, and Materiel Command, Fort Detrick, MD. Dr. Faina Shtern, President of AdMeTech Foundation said, "In the '90s, the American College of Radiology led development of the BI-RADS standardization of breast cancer imaging which transformed women's health. Over the last several years, ESUR led the way in the development of proposed clinical reporting guidelines for prostate MRI."

source: PR Newswire