FDA reviewers stay red hot in September

November 9, 2006

The imaging industry tallied another 34 FDA clearances in September, pushing the running count for the year to 261. Image management led all categories with 14 devices, followed by x-ray with 10, radiotherapy with four, ultrasound and CT each with two, and nuclear medicine with one. A surgical microscope accessory that is used to view intraoperative cerebral blood flow fits none of the traditional categories.

The imaging industry tallied another 34 FDA clearances in September, pushing the running count for the year to 261. Image management led all categories with 14 devices, followed by x-ray with 10, radiotherapy with four, ultrasound and CT each with two, and nuclear medicine with one. A surgical microscope accessory that is used to view intraoperative cerebral blood flow fits none of the traditional categories.

In image management, software created by Advanced Image Enhancement improves the overall ability of interpreters to resolve abnormalities, increasing sharpness and clarity of subtle image features found in digital mammograms. The software, Region of Interest Image Enhancement for Digital Mammography, may be used to display, manipulate, and interpret lossless compressed or noncompressed mammograms for screening and diagnosis.

In x-ray, Philips' EP Navigator allows users to segment previously acquired 3D CT data sets, and then overlay and register the data sets with live fluoro x-ray images of the same anatomy acquired with a Philips Allura Xper FD angiography x-ray system. The registered images are used to guide catheter/device navigation during interventional procedures.

In a separate clearance, Philips' 3D-RX option extends the functionality of the BV Pulsera Release 2.2 to support volumetric reconstructions from digital radiography data. Images obtained during a rotational scan are transformed using an integrated 3D workstation.

Giotto USA's Biopsy Digit AM is designed for mammographic procedures requiring stereotactic guidance, such as fine-needle aspiration, needle biopsy, and guidewire placement. It uses two stereo images taken by a digital solid-state camera to determine the location of a lesion in three dimensions. The coordinates of the lesion are used to position a needle holder that guides the tip of the needle or guidewire to the predetermined coordinates.

In CT, Gentle Colon revision 2.0 by Rendoscopy processes interactive 3D views from 2D slices obtained with CT. The software loads data from the CT automatically. Algorithms create surfaces with contrast resolution higher than the 2D axial cuts, according to the company. Multipath tracking allows pathfinding over collapsed or liquid-filled parts of the colon.

Philips and Neusoft of China gained clearances for their NeuViz Dual CT systems, which produce two slices per rotation. Two variants, NeuViz Dual (H) and NeuViz Dual (L), were cleared by the FDA. The main difference is tube capacity.

In nuclear medicine, GE Healthcare's Vantage promises to aid in the assessment and quantification of pathologies found in PET and PET/CT brain scans. The software realigns the PET volume to images found in a standard brain atlas and compares it to brain scans derived from control subjects or prior PET or MR scans. The results are displayed graphically as Z-scores, where the Z-score is the scale of deviation from the normal mean relative to corresponding standard deviation. Vantage runs on GE's Advantage Workstation and PET/CT scanner console and is organized as a series of workflows steps specific to use with particular drug and disease combinations.