The U.S. Food and Drug Administration (FDA) and Health Canada have approved the use of the Maria Research Reactor in Poland as a site to irradiate highly-enriched uranium targets for molybdenum-99 (Mo-99) production, according to Covidien.
Biospace Med has entered into a distribution agreement with medical diagnostic imaging company Oldelft Benelux for the employment of its 2D/3D x-ray image technology, EOS.
Written by Mary Stevens
ATLANTA -- The government doesn’t want to be in the software business, said Vish Sankaran, Federal Healthcare Architecture (FHA) program director at the Office of the National Coordinator for Health IT. Sankaran described the FHA’s work on CONNECT in an interview with CMIO.
Loss of patient data and prescription errors are just two potential safety risks associated with health IT (HIT) adoption. As the FDA examines these issues, the agency is questioning how to better regulate this new electronic field and which branch of government oversight is best suited to monitor such safety concerns.
FDA has reported several cases where radiologic technologists at mammography facilities falsified quality control (QC) records (processor QC testing, phantom image QC testing or both), and other technologists falsified registration cards from the American Registry of Radiologic Technologists.
Naviscan has reported that its Positron Emission Mammography (PEM) scanner will be utilized in pre-clinical and translational research for the development of radiotracers by Richard Wahl, MD, professor of radiology and nuclear medicine at the Johns Hopkins School of Medicine in Baltimore.
In 2006, the Center for Devices and Radiological Health (CDRH), a branch of the FDA, began examining the number of medical device reports they received. Over the past two years, the number of submitted reports has increased, sparking a demand for the CDRH to make a move to electronic reporting.
GE Healthcare has released Vscan, a pocket-sized visualization tool developed to provide physicians with imaging capabilities at the point of care.
The FDA today launched an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: CT, nuclear medicine studies and fluoroscopy.
The Viamo laptop ultrasound system from Toshiba America Medical Systems, a hand-carried system that was introduced at the 2009 Radiological Society of North America (RSNA) annual meeting, has received FDA clearance.
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Rcadia Medical Imaging has been issued a CE Mark for its computer-aided detection software--the COR Analyzer system--that helps identify patients with significant coronary artery disease by an analysis of coronary CT angiography (CCTA) studies.
PETNET Solutions, a subsidiary of Siemens Medical Solutions, is preparing to distribute NaF-18 (sodium fluoride-18) through its network of 47 PET radiopharmacies in the U.S. in support of the Centers for Medicare & Medicaid Services (CMS) memorandum to allow for coverage with evidence development of NaF-18 PET imaging.
Written by Mary C. Tierney
Concern for imaging-based patient radiation dose continues its surge. Recent patient radiation overexposure cases in the U.S., multiple studies relating CT scans to higher incidences of cancer and extensive media reporting on radiation exposure have given the issue of radiation exposure during imaging exams an increasingly high profile.
Cleveland BioLabs has submitted a response to the request for proposal issued by the Department of Defense (DoD) for the FDA approval/licensure and delivery of a medical radiation countermeasure.
The FDA and the National Institutes of Health (NIH) have begun a collaborative effort in which the agencies will establish a Joint NIH-FDA Leadership Council to work on important public health issues, further scientific efforts and make innovative medical therapies available to patients, said the agencies.
In a letter to FDA Commissioner Margaret A. Hamburg, Senator Chuck Grassley (R-Iowa) asked for an update on the implementation of new guidelines for medical device makers on when they need to file new information with the agency and seek clearance for the marketing and use of modified devices under the 510(k) system.
Covidien and the Institute of Atomic Energy in Poland have agreed to augment the global supply of molybdenum-99 (Mo-99) by adding the Poland’s Maria Research Reactor to the company's supply chain.
The FDA has granted clearance for the marketing of the Eagle Eye Platinum digital intravascular ultrasound (IVUS) catheter in the U.S. by intravascular systems developer, Volcano.
The FDA issued a final guidance on Bayesian statistical methods used in the design and analysis of medical device clinical trials on Feb. 5, allowing for medical device companies to combine trial data.
Clinical image visualization and analysis software company Shina Systems will begin to offer its 3Di cloud-based medical imaging visualization software, after receiving clearance from the FDA.
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The use of health IT to reduce rehospitalizations will be welcome but also disruptive, said Stephen Jencks, an independent consultant in healthcare safety during a Feb. 24 webinar on the potential use of health IT to mitigate rehospitalizations, sponsored by the Agency for Healthcare Research and Quality (AHRQ).
During the Health IT Standards Committee meeting on Feb. 24 in Washington, D.C., the Clinical Operations Workgroup sought to gather comments on proposed recommendations on implementation specifications for content exchange, vocabulary and code set standards for the Interim Final Rule of meaningful use.
In 2006, the Center for Devices and Radiological Health (CDRH), a branch of the FDA, began examining the number of medical device reports they received. Over the past two years, the number of submitted reports has increased, sparking a demand for the CDRH to make a move to electronic reporting.
A new hospital breaking ground usually isn’t breaking news. But the vision of patient care at one new facility, tentatively named Palomar Medical Center West (PMC West), is currently illegal under California state law.