Laser mammography moves toward PMA

Imaging Diagnostic Systems' hopes of joining the mammography sweepstakes are pinned on its computed tomography laser mammography (CTLM) system gaining FDA premarket approval next year.

IDS in Plantation, FL, has been developing its system for several years. It hopes to complete the PMA process early in 2001. Another company, Advanced Research and Technology (ART) of Montreal, is working on a similar system, called SoftScan.

Both SoftScan and IDS's CTLM system train the laser energy on one side of the breast and place a detector on the other side to catch the photons after they pass through the tissue.

The ART system uses a stationary light source to create 2-D images, whereas CTLM's lasers rotate around the breast to create 3-D tomographic images. ART likewise hopes to clear the FDA in 2001 and begin marketing its product in 2002.

Both systems are considered adjuncts to x-ray mammography. n