PEM gets FDA nod for breast imaging device

Molecular imaging developer PEM Technologies has received Food and Drug Administration 510(k) clearance for a device that applies compression during scintigraphic breast imaging. The device is intended to support, position, and immobilize the breast during imaging examinations with injectable agents, according to the Bethesda, MD-based manufacturer. The device is currently being employed at Harbor-UCLA Medical Center in a clinical trial assessing the sensitivity of breast imaging agents.

PEM Technologies sold its first full-field research PET scanner this past quarter, and is in discussions with several major medical device companies concerning strategic alliances for the development and marketing of PET-based breast imaging systems, according to the vendor.

Other PEM products under development for imaging and minimally invasive surgery include a handheld PET scanner for breast and prostate imaging, and a pathology tool for imaging cancer cells in surgical specimens.

By AuntMinnie.com staff writers
February 14, 2001

Copyright ยฉ 2001 AuntMinnie.com

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