Positron, through its wholly owned subsidiary, Manhattan Isotope Technology (MIT), has executed a memorandum of understanding with the Institute of Nuclear Research (INR) of Troitsk, Russia. MIT and INR will collaborate on strontium-82 production beginning with a pharmaceutical ingredient validation exercise in 2012.
Six current and former employees of the FDA—all scientists and physicians who worked on reviewing medical devices—have filed suit against the agency, accusing it of spying on their computer activities. The six allege that they were placed under secret surveillance because they had warned Congress that FDA was hastily approving risky devices.
The FDA’s Center for Devices and Radiological Health (CDRH) has released its ombudsman report for 2011, the first year the office’s electronic tracking system has been used to facilitate record-keeping and trending.
The diagnostic imaging market will be marked by an expansion of hybrid modality technology, the growth of imaging in emerging markets and negative growth due to reimbursement cuts in the U.S., according to a report by GBI Research, a business information company, distributed by Industry Review.
Naviscan PET scanners performing positron emission mammography (PEM) have been installed in two European centers: Radiologie und Nuklearmedizin in Ludwigshafen, Germany, and Medica in Istanbul, Turkey.
As a woman ages, her chances of being diagnosed with a lower-risk breast tumor increase, according to a study published in the December 2011 issue of Breast Cancer Research and Treatment. The study showed that for women over age 50, a substantial number of cancers detected by mammograms have good prognoses.
The FDA has released preliminary information from the ongoing investigation of the improper usage of CardioGen-82 (Bracco Diagnostics). The agency said that certain clinical sites are responsible for the exposure of some patients to more radiation than is typically associated with a CardioGen-82 scan. A voluntary recall of CardioGen-82 was launched on July 25, 2011.
University of Texas (UT) Southwestern Medical Center in Dallas has installed a PET scanner, the breast application for which is positron emission mammography (PEM), which will be used both for clinical patients as well as for research focused on lowering radiation dose and novel radiotracers.
The FDA has granted clearances for GE Healthcare's Brivo NM615, a single-head nuclear medicine gamma camera with SPECT capability.
The FDA has issued draft guidance to clarify current review practices of premarket notification 510(k) submissions for FDA staff and manufacturers of medical devices.
The FDA has released draft guidance aimed at increasing the number of women participating in clinical trials for medical devices.
Medical device makers are counting on financial stratagems—buybacks, dividends, acquisitions and the like—to keep shareholders happy in the face of flat sales figures. The drop in demand owes in large part to belt-tightening at hospitals, tougher approval procedures at the FDA, declining medical coverage under health-insurance plans and a weak global economy.
Covidien is planning to spin off its pharmaceuticals business into a standalone public company. The unit supplies generators used to produce technetium-99m, a medical isotope, and offers an integrated system of diagnostic contrast media in prefilled syringes and injectors.
New Jersey has seen a 14 percent increase in medical-device manufacturing jobs over the past couple of years—from around 18,000 to 20,500—“which is so promising because that means the industry is growing, even in tough economic times.”
Royal Philips Electronics has received 510(k) clearance from the FDA for its whole-body PET/MR imaging system, the Ingenuity TF PET/MR. The system was on display at the 97th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), Nov. 27 to Dec. 2.
Written by Douglas Page
The final diagnostic form the evolving hybrid PET/MR tree will take is uncertain, but it has already begun to blossom. Thus, the low-hanging clinical fruit has lured a number of medical centers to early adoption. Experts weigh in on the potential that PET/MR may hold for various neurologic, oncologic and cardiovascular conditions.
Written by Justine Cadet
Molecular breast imaging is proving its worth as an low-dose alternative to MRI for women with dense breasts. Sponsored by an educational grant from Gamma Medica
The FDA has sent a warning letter to International Isotopes, a radiochemical product manufacturer based in Idaho Falls, Idaho, due to violations of Current Good Manufacturing Practice regulations.
Written by Manjula Puthenedam
This article discusses the recent updates in Alzheimer’s detection using amyloid PET radiotracer 18F-flutemetamol, proteins in the cerebrospinal fluid and blood.
PETNET Solutions, a wholly owned subsidiary of Siemens Medical Solutions USA, has entered into a commercial agreement with Eli Lilly that grants Siemens PETNET the right to manufacture and distribute Lilly’s molecular imaging agent that is currently under review by the FDA for PET imaging.
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