CTI Mirada wins FDA approval to market its Scenium PET scan analysis
18 January 2005
CTI Molecular Imaging, Inc. (Nasdaq: CTMI), a provider of positron
emission tomography (PET) equipment, molecular biomarkers and services, has
announced that its subsidiary CTI Mirada Solutions, has been awarded FDA
510(k) clearance to market Scenium, an innovative new quantification tool
for the analysis of neurological positron emission tomography (PET) scans.
Scenium display and analysis software has been developed to aid
clinicians in accurate assessment and quantification of dementia and other
neurological diseases. Initially developed for use in PET studies with
fluorodeoxyglucose (FDG), Scenium has the potential to be used with other
PET molecular imaging agents in the future.
The software is organized as a series of workflows, each is specific to a
particular radiopharmaceutical and disease combination. Based on Mirada's
established image fusion techniques, Scenium enables clinicians to compare
patients' brain scans to standard normal scans, highlighting differences in
uptake. Multiple anatomical regions are highlighted for quick assessment of
an image and quantitative comparison with other images and integration into
the current reporting workflow of the imaging centre.
The software will be available as a plug-in to a wide variety of viewing
workstations, and also for use on a standard PC.
"Developed in direct response to the rapidly expanding market for
quantification software, Scenium is expected to achieve a widespread install
base during 2005, particularly with the recent approval for reimbursement
for some neurological FDG scans," said Christian P Behrenbruch, President of
CTI Mirada Solutions.
Mirada plans to release Scenium during spring 2005, following product
optimization based on current field trials. The software will be distributed
by CTI PETNET, as well as Mirada's OEM/PACS partners.
Additional information is available