My understanding for the US is that:
1) if a software provides information to a clinician, and not a
diagnosis, and the diagnosis is left to the physicians then the
liability falls on the physician making the decision and is covered by
e.g. Volume of ROI has grown by 10% between two scans.
2) If a software provides a diagnostic which can trigger subsequent
actions then it would have to be FDA approved in itself.
e.g. The ROI is a malignant Tumor.
Olivier Salvado, PhD
Team Leader, Biomedical Imaging
eHealth Research Centre - CSIRO ICT Centre
Phone +61 7 3024 1658
Fax +61 7 3024 1690
Mobile +61 4 0388 2249
From: SPM (Statistical Parametric Mapping) [mailto:[log in to unmask]]
On Behalf Of Woo-Suk, Tae
Sent: Thursday, 6 December 2007 5:41 PM
To: [log in to unmask]
Subject: [SPM] FDA approved neuroimaging software
Dear SPM community lists.
Who can recommend FDA approved neuroimaging software such as Analyze
(BIR, Mayo clinic) to me?
The functions of image registration, segmentation, image algebra,
multi-objects 3D visualization are needed.
Woo Suk, Tae Ph.D.