The FDA announced today that it cleared the Siemens AG (NYSE:SI) Biograph, the first device to perform positron emission tomography scanning and magnetic resonance imaging scanning at the same time.
PET scans allow physicians to see how organs are functioning by injecting radioactive tracers into a patient’s blood stream and MRIs use magnetic fields and radiowaves to create detailed images of organs, soft tissues, bones and other body structures.
Siemens’ Biograph device allow patients to get both scans at once, reducing radiation doses and saving time while providing a higher level of soft tissue contrast.
The FDA cleared the Biograph system based on tests that compared it to an existing scanner that combines PET with computer tomography scanning, which uses X-rays to make images.
The MRI/PET combination allowed physicians to acquire images at a significantly lower radiation dose, as compared with CT/PET scans, according to the release.
The device also won CE Mark in the European Union this week, according to MedGadget.
Advanced Cardiac Therapeutics, Inc., a developer of temperature-sensing heart treatment devices, announced that its Tempasure catheter system for atrial arrhythmias won CE Mark in the European Union this week. The device is the world’s first ablation catheter to offer saline irrigation and temperature-sensing technology, according to company officials. The Laguna Beach, Calif.-based company began European clinical trials in March.
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GE Healthcare (NYSE:GE) announced that its AngioViz application, which provides X-ray images of blood vessels in two dimensions, received clearance by the FDA. The software analyzes each pixel in the X-ray images to help physicians better perceive aspects of the blood’s flow.
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Medegrip, a small foam device for working with small or breakable objects in clinical settings, won CE Mark in the European Union. The device was designed by a PICC line nurse, and was successfully registered with the FDA as a Class 1 device less than a month ago. Access Scientific Inc. included the product with its PowerWand maximum barrier kit, MedGadget reported.
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