FDA clears Siemens 16-slice TruePoint PET/CT; files imaging agent app

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Siemens Healthcare has obtained FDA 510(k) clearance for its Biograph TruePoint 16-slice PET/CT system, which is now commercially available. The company has also filed an exploratory Investigational New Drug (eIND) application with the FDA for an agent to image amyloid plaque, which is associated with Alzheimer's Disease.

The new TruePoint system features high-definition PET and routine 10-minute, whole-body imaging. In addition, the Biograph TruePoint 16 is able to provide 2 mm uniform PET resolution throughout the field of view and delivers a two-time improvement in signal-to-noise ratio, which enables small lesion detection, the company said. The system is also available with TrueV extended PET field of view technology, which enables clinicians to perform imaging studies at twice the scan speed or half the patient dose, according to Siemens. It features a 500-pound capacity patient bed with a 70-centimeter patient bore.

The Biograph TruePoint 16-slice PET/CT system has been FDA-cleared under the name Siemens Medical Solutions USA.

New Imaging Agent

The eIND is for a new plaque imaging agent, [18F]-SMIBR-W372, that when imaged using PET, has been designed to seek out amyloid plaques in the living human brain. Together with other agents developed in the program, Siemens said that [18F]-SMIBR-W372 may assist in achieving its goal of diagnosing Alzheimer's disease in its earliest stages.

The exploratory eIND application with the FDA has been filed under Siemens Medical Solutions USA.