Medrad receives FDA clearance for NaF PET infusion system
Medrad, a unit of Bayer HealthCare, has received FDA clearance to market its Intego PET infusion system for 18F-Sodium Fluoride (NaF) administration in PET imaging to find and assess bone metastases.
According to the Warrendale, Pa.-based Medrad, Intego is the only multi-PET agent infusion system currently cleared by the FDA, and Medrad received FDA clearance for 18F-FDG administration in 2008.
The 18F-NaF PET imaging is covered by the Centers for Medicare & Medicaid Services for beneficiaries under coverage with evidence development program.
According to the Warrendale, Pa.-based Medrad, Intego is the only multi-PET agent infusion system currently cleared by the FDA, and Medrad received FDA clearance for 18F-FDG administration in 2008.
The 18F-NaF PET imaging is covered by the Centers for Medicare & Medicaid Services for beneficiaries under coverage with evidence development program.