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MEDRAD received FDA clearance to market the MEDRAD Intego PET Infusion System (Intego) for Sodium Fluoride (F18-NaF) administration in positron emission tomography ( PET ) imaging.

MEDRAD , Inc. a business of Bayer Medical Care has received FDA clearance* to market the MEDRAD Intego PET Infusion System (Intego) for Sodium Fluoride (F18-NaF) administration in positron emission tomography ( 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 a very 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 fluoro-deoxy-glucose (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 multi-dose vial and nuclear medicine technologists can dose on demand from a touchscreen to enable precise, flexible, safe, and efficient administration of PET agents.  MEDRAD Intego systems are in place in hospitals and clinics throughout the US, Europe, Australia, and the Middle East.     

“ MEDRAD believes in the power and potential of molecular imaging and diagnostics.  We plan to continue to innovate and create solutions for clinicians and researchers to enable the science and provide benefit to patients,” said Doug Descalzi, executive director of molecular imaging for MEDRAD.    

* FDA Clearance Letter, K100798.
** Decision Memo for positron emission tomography to Identify Bone Metastasis of Cancer (CAG-00065R) http://www.cms.gov/mcd/viewdecisionmemo.asp

Source: MEDRAD