FDA clears Park Medical's digital dual-head

The Food and Drug Administrationinformed Canadian nuclear medicine vendor Park Medical Systemslast week that its Isocam 2 digital dual-head gamma camera hasbeen cleared for marketing. Park, of Lachine, Quebec, is now poisedto take a run at other manufacturers of digital cameras, as wellas variable-angle dual-head vendors ADAC Laboratories and SophaMedical.

Park debuted Isocam 2 at this year's Society of Nuclear Medicinemeeting in Orlando. The system features Park's spectral mode acquisitionin real time (SMART) digital detector, which is a departure fromAnger-based gamma cameras, according to the company. The cameraconverts analog nuclear signals to digital form within individualphotomultiplier tubes, thus enhancing its ability to positionand measure nuclear events.

Park's single-head digital camera, Isocam 1, received FDA clearancelast year (SCAN 2/19/93). Sales of Isocam 1 have been slow tomaterialize, however, due to the company's low profile and smallsales force. Isocam 2 will be Park's lead product as it buildsits sales and marketing team.

Isocam 2 has a robotic gantry that is capable of several distinctconfigurations, including 90º positioning for cardiac studies,as well as slip-ring rotation. The camera also supports simultaneousmulti-isotope imaging from 50 to 560 KeV and features large 22.3x 16.5-inch detectors in which the entire face of the detectoris available for clinical use. Park has also developed a remotediagnostic capability for its cameras, according to presidentand CEO Richard Mullen.