Navidea Biopharmaceuticals has received notification from the FDA that the Prescription Drug User Fee Act (PDUFA) date for 99m-Tc-Tilmanocept (Lymphoseek) has been pushed back to Sept. 10, a 90-day extension from the initial PDUFA date of June 10. Lymphoseek is an investigational radioactive tracing agent for lymphatic mapping and lymphoscintigraphy.

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FDG PET could be used as a noninvasive surrogate marker for tumor growth and viability in treatment of head and neck cancer, based on a rodent model study published in the December issue of Radiology.

The Molecular Imaging Biomarker Research Group of Siemens Medical Solutions USA has completed a Phase II multicenter clinical trial of its HX4 positron PET imaging biomarker, which is designed to detect hypoxia—a reduction in tissue oxygen levels—in solid tumors.

Infinitt North America, a developer of image and information management technologies for healthcare, has received FDA clearance for its fusion software, Xelis Fusion. The software is now available to the North American market.