Listings are for information only and do not constitute endorsements.
Multi-tasking surgical device
The Food and Drug Administration has approved a new imaging system that identifies sites on the cervix that may contain precancerous cells. Manufactured by MediSpectra, Inc. (Lexington, Mass.), the LUMA Cervical Imaging System is meant to be used along with colposcopic evaluation of the cervix for women with recent abnormal Pap results. According to the company, results of its study showed that the device can detect additional cancer precursors missed by colposcopy. Of 50 cases of precancer detected in the study, colposcopy caught 41 cases of cervical precancer compared to LUMA's catching an additional nine that colposcopy missed.
The FDA approval was based on the company's clinical study of 193 women who underwent colposcopy, followed by LUMA. The FDA found that the device is safe and effective and that-when used in conjunction with colposcopy-will help detect additional cervical cancer precursors. For more information, visit the company's Web site at http:// http://www.medispectra.com/.
Calcitonin ELISA kit
The BIOMERICA Calcitonin ELISA Kit is an FDA-cleared product used to determine blood levels of the hormone calcitonin. Intended for in vitro diagnosis, the assay is used not only to diagnose thyroid cancer, but also as an adjunct for monitoring a patient's osteoporosis. The kit contains microwell strips and enough reagents to test up to 88 patients. With a shelf life of 12 months when stored at 2°C to 8°C , the test is a direct label two-site ELISA. For more information, call Patrick Garcia at 949-645-2111.