Technology | July 07, 2010

FDA Clears Medrad Intego for Use in PET Imaging

July 7, 2010 – The U.S. Food and Drug Administration (FDA) has granted Medrad Inc. clearance to market the Medrad Intego positron emission tomography (PET) infusion system for sodium fluoride (F18-NaF) administration in PET imaging. F18-NaF PET is most frequently used in oncology to find and assess bone metastases.

With its rapid uptake in the bone and quick bone clearance, there is growing clinical evidence of the value of F18-NaF as an effective diagnostic imaging agent in bone cancer imaging. PET technology provides high-resolution images that may be quantified for detailed and comparative analysis. It is these benefits, in part, that led the Center for Medicare and Medicaid Services (CMS) to announce plans in February 2010 to cover F18-NaF PET imaging for beneficiaries under a Coverage with Evidence Development program.

Receiving FDA clearance for F18 fluorodeoxyglucose (F18-FDG) administration in 2008, Intego is the only multi-PET agent infusion system currently cleared by the FDA. The system is loaded with a multidose vial, and nuclear medicine technologists can dose on demand from a touch screen to enable precise, flexible, safe and efficient administration of PET agents.

Medrad Intego systems are in place in hospitals and clinics throughout the U.S., Europe, Australia and the Middle East.

Related Content

Study Finds No Evidence that Gadolinium Causes Neurologic Harm

MR images through, A, C, E, basal ganglia and, B, D, F, posterior fossa at level of dentate nucleus. Images are shown for, A, B, control group patient 4, and the, C, D, first and, E, F, last examinations performed in contrast group patient 13. Regions of interest used in quantification of signal intensity are shown as dashed lines for globus pallidus (green), thalamus (blue), dentate nucleus (yellow), and pons (red).

News | Contrast Media | January 11, 2018
January 11, 2018 — There is no evidence that accumulation in the brain of the element gadolinium speeds cognitive dec
Male Triathletes May Be Putting Their Heart Health at Risk
News | Cardiac Imaging | January 09, 2018
Competitive male triathletes face a higher risk of a potentially harmful heart condition called myocardial fibrosis,...
PET Tracer Gauges Effectiveness of Promising Alzheimer's Treatment

Longitudinal PET imaging with 18F-AV45. PET imaging shows the average 18F-AV45 uptake per animal group at 8 and 13 months of age. A significant interaction of genotype treatment was observed in the cortex (p = 0.0248), hippocampus (p = 0.0071) and thalamus (p = 0.0084), indicating reduced [18F]-AV45 uptake in BACE1 inhibited transgenic mice. Credit: MICA, University of Antwerp, Belgium.

News | Radiopharmaceuticals and Tracers | December 28, 2017
In the December featured basic science article in The Journal of Nuclear Medicine, Belgian researchers report on the...
Videos | Magnetic Resonance Imaging (MRI) | December 19, 2017
Emanuel Kanal, M.D., director of MRI services and professor of radiology and neuroradiology at the University of Pitt
The FDA issued new warnings on MRI gadolinium contrast agents. (GBCAs)

The FDA issued new warnings on MRI gadolinium contrast agents. 

Feature | Magnetic Resonance Imaging (MRI) | December 19, 2017
The U.S.
Brainlab Contrast Clearance Analysis Software Receives FDA 510(k) Clearance
Technology | Contrast Media | December 12, 2017
Brainlab announced U.S. Food and Drug Administration (FDA) clearance of its Contrast Clearance Analysis methodology,...
Sectra Offers Gadolinium Tracking Functionality in DoseTrack Software
Technology | Contrast Media | December 11, 2017
December 11, 2017 — Sectra recently announced the global introduction of gadolinium tracking in its dose monitoring s
Videos | Magnetic Resonance Imaging (MRI) | December 07, 2017
Max Wintermark, M.D., professor of radiology and chief of neuroradiology, Stanford Hospital and Clinics, discussed MR
Michael J. Fox Foundation and Tau Consortium Developing PET Tracers for Neurodegenerative Disease
News | Radiopharmaceuticals and Tracers | October 27, 2017
The Michael J. Fox Foundation for Parkinson's Research (MJFF) and the Tau Consortium announced a funding partnership to...
Guerbet to Participate in French Interventional Radiology Conference
News | Contrast Media | October 10, 2017
Guerbet announced it will be taking part in the 65th edition of the Journées Francophones de Radiologie (JFR) that will...
Overlay Init