These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis. A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.
A new study reports that the use of a quarterly report card is associated with improved colonoscopy quality indicators. Endoscopists at the Roudebush Veterans Affairs Medical Center in Indianapolis, Ind., who participated in the study showed an overall adjusted adenoma (precancerous polyp) detection rate increase from 44.7 percent to 53.9 percent, and a cecal intubation rate increase from 95.6 percent to 98.1 percent.
Royal Philips (NYSE: PHG, AEX: PHIA) today announced new capabilities for its Iterative Model Reconstruction (IMR) technology, a knowledge-based iterative reconstruction technique, that will simultaneously bring enhanced benefits to clinicians and patients.
Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that the final results of the PUFs (Pipeline for Uncoilable or Failed Aneurysms) clinical study of its Pipeline™ embolization device have been published in the June issue of Radiology. Radiology is the official peer-reviewed medical journal of the Radiological Society of North America.
Covidien (NYSE:COV) has announced that the final results of the PUFs (Pipeline for Uncoilable or Failed Aneurysms) clinical study of its Pipeline embolization device have been published in the June issue of Radiology.
A new University of Florida study suggests a promising brain-imaging technique has the potential to improve diagnoses for the millions of people with movement disorders such as Parkinson’s disease. Utilizing the diffusion tensor imaging technique, as it is known, could allow clinicians to assess people earlier, leading to improved treatment interventions and therapies for patients.
Varian Medical Systems (NYSE:VAR) and Siemens Healthcare today announced that clinicians at The Ohio State University (Ohio State) are now using Varian software to plan and manage radiotherapy treatments delivered on a Siemens medical linear accelerator.
Mindray Medical International Limited has announced a definitive agreement to acquire ZONARE Medical Systems, Inc., an ultrasound technology leader in the high-end radiology segment for US$105 million. Mindray's management expects the deal to strengthen its high-end ultrasound R&D and U.S. sales capabilities, furthering the company's goal of becoming a leading provider of high-quality imaging products to markets worldwide.
Diagnostic technology covers a broad range of equipment, tests, and medical fields, and recent advancements in technique and materials means that innovations are widespread and growing rapidly. Though economic conditions are preventing huge advancements in diagnostic imaging—if hospitals can’t afford the new technology, there is no point in designing it—the medical imaging community is focusing on refinement, rather than redesign.
Wake Forest Baptist Medical Center doctors have found that using stress cardiac magnetic resonance (CMR) imaging in an Emergency Department observation unit to care for patients with acute chest pain is a win-win - for the patient and the institution.
Just a few years ago, integrated positron emission tomography and magnetic resonance (PET/MR) imaging was found only in research institutes, but little by little the technology has expanded into clinical practice. This is especially true for cardiac indications, for which the highly sensitive soft tissue contrast of MR and the functional and metabolic imaging of PET are particularly valuable.
Coronary artery disease (CAD) is one of the world’s most prevalent and silent killers. Positron emission tomography (PET), which images miniscule abnormalities in cellular metabolism, can tip off clinicians about cardiac disasters waiting to happen—including sudden death from a heart attack—better than standard angiography, researchers revealed at the Society of Nuclear Medicine and Molecular Imaging’s 2013 Annual Meeting.
A relatively new weapon in the fight against childhood brain cancer has emerged that improves upon standard magnetic resonance imaging (MRI) by providing information about tumor metabolism and extent of cancer in children diagnosed with glioma, a growth caused by the abnormal division of glial cells in the brain, say researchers at the Society of Nuclear Medicine and Molecular Imaging’s 2013 Annual Meeting.
One of the biggest hurdles of hybrid positron emission tomography and magnetic resonance (PET/MR) imaging is the prevalence of motion artifacts—blurring and ghostly visual anomalies caused by patient motion on the table during imaging. An MR technology has now been designed for PET/MR that employs tiny radiofrequency solenoids—metal coils integrated into hardware placed on the body—to track motion from those who do not or cannot stay put.
The Society of Nuclear Medicine and Molecular Imaging’s 2013 Annual Meeting marks the unveiling of the successful application of a new preclinical hybrid molecular imaging system—single photon emission tomography and magnetic resonance—which has exceptional molecular imaging capabilities in terms of potential preclinical and clinical applications, technological advancement at a lower cost, and reduction of patient exposure to radiation.
Soccer players who 'head' the ball with high frequency demonstrate poorer performance on memory tests and have brain abnormalities similar to those found in traumatic brain injury patients, according to a study published online in the journal Radiology.
New research analyzing breast cancer mortality data spanning almost 40 years concludes that breast cancer screening does not yet show an effect on mortality statistics. The research, published in the Journal of the Royal Society of Medicine, analyzed mortality trends before and after the introduction of the National Health Service Breast Screening Programme in 1988.
A study examining trends in X-ray computed tomography (CT) use in children in the United States has found that reducing unnecessary scans and lowering the doses for the highest-dose scans could lower the overall lifetime risk of future imaging-related cancers by 62 percent. The research by a UC Davis Health System scientist is published online today in JAMA Pediatrics.
Ingestible medical devices offer a convenient, non-invasive method of delivering therapeutics, enabling diagnostic procedures, or performing imaging tasks. However, ensuring that the sensitive electronics within the device are protected is a challenge. This article will highlight a coating technology that is being used to guarantee such protection is provided.
Blood vessels within a sensory area of the mammalian brain loop and connect in unexpected ways, a new map has revealed. The study, published June 9 in the early online edition of Nature Neuroscience, describes vascular architecture within a well-known region of the cerebral cortex and explores what that structure means for functional imaging of the brain and the onset of a kind of dementia.
MRI scans of children who have had chemotherapy can detect early changes in their hearts finds research in biomed Central's open access journal Journal of Cardiovascular Magnetic Resonance. Chemotherapy with anthracyclines, such as Doxorubicin, is one of the most effective treatments against many types of cancer, including leukaemia and Hodgkin's lymphoma, breast, lung, and ovarian cancer.
A new study has found that women can be screened for colorectal cancer at least five to 10 years later than men when undergoing an initial "virtual colonoscopy." Published early online in CANCER, a peer-reviewed journal of the American Cancer Society, the findings may help establish guidelines for the use of this screening technique, which is less invasive than a traditional colonoscopy.
Scientists from ICFO- Institute of Photonic Science, in collaboration with researchers from the Catalan Institute of Nanotechnology (ICN2) and the University of Michigan, have been able to measure weak forces with sensitivity 50 times higher than what has been achieved to date. This significant improvement represents a turning point in measuring very weak forces and opens the door for magnetic resonance imaging at the molecular scale.
Three out of 20 flexible gastrointestinal (GI) endoscopes used for screening were found to harbor unacceptable levels of "bio dirt" – cells and matter from a patient's body that could pose potential infection risk -- according to a study of endoscopes used at five hospitals across the U.S.
A landmark study, with first author Tyson Oberndorfer, MD, and led by Walter H. Kaye, MD, professor of psychiatry at the University of California, San Diego School of Medicine, suggests that the altered function of neural circuitry contributes to restricted eating in anorexia and overeating in bulimia.