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The FDA has approved the ThinPrep Imaging System (Imager), a device that uses computer imaging technology to assist in primary cervical cancer screening of ThinPrep Pap Test slides, according to Cytyc Corp. In conjunction with the test itself, which was approved in 1996, the approval permits Cytyc to offer an integrated cervical cancer screening system, said a spokesman for the Boxborough, Mass.-based company. The automated imaging and review system combines imaging technology to identify microscopic fields of diagnostic interest with automated stage movement of a microscope to locate these fields.
The federal agency based its approval on the results of a multi-site trial that compared routine screening of ThinPrep slides using the Imaging System with a manual review of ThinPrep slides; they also evaluated cytotechnologist screening rates. Among the study's findings were that the Imager Review method showed statistically significant improved sensitivity over the manual method for all sites combined for ASCUS+. Cytyc believes the product has the potential to help cytotechnologists improve accuracy while screening up to 200 slides daily. For more information, visit the company's Web site at http://www.cytyc.com .
The Food and Drug Administration has approved a new low-dose strength of Prempro (conjugated estrogens[CE]/medroxyproges-terone acetate [MPA] containing 0.3 mg CE and 1.5 mg MPA. The product received a green light for the treatment of moderate-to-severe vasomotor symptoms associated with menopause and also for the prevention of osteoporosis, according to Wyeth Pharmaceuticals (Madison, N.J.). In addition, the FDA expanded the approved uses for recently approved Prempro 0.45 mg/ 1.5 mg to include prevention of postmenopausal osteoporosis. Prempro 0.45 mg/1.5 mg is expected to be available in early summer, and Prempro 0.3 mg/1.5 mg in late 2003.
The action comes on the heels of the agency's recent approval of a new low-dose (0.45 mg) strength of estrogen-only Premarin (CE tablets), which contains 28% less estrogen than the standard 0.625-mg dose, and is for hysterectomized women.
The FDA, other experts, and Wyeth recommend that women take the lowest dose of postmenopausal therapy for the shortest duration consistent with treatment goals and risks for the individual woman. Identical data support the efficacy and tolerability of both estrogen only and combination therapy and are based on the Women's Health, Osteoporosis, Progestin, Estrogen (HOPE) Study. For more information, visit http://www.Wyeth.com .
Better patient compliance is the goal of the newest take-home colon Ca screening test from Beckman Coulter Primary Care Diagnostics (Palo Alto, Calif.). The Hemoccult II SENSA elite, a fecal occult blood test, is not only more user friendly than the company's previous screening test, with easier-to-understand instructions for patients and labs alike, but is designed to speed lab processing, according to the manufacturer. The test package contains a simplified Test Card and a redesigned triple-slide facilitates lab interpretation.
Other improvements are easier sampling and fewer diet restrictions. There's also an educational FOBT Web site, http://www.hemooccultFOBT.com and other materials to educate patients and physicians about the test and the product itself.
The California STD/HIV Prevention Training Center (CA PTC), which specializes in training clinicians in the prevention, diagnosis, treatment, and management of sexually transmitted diseases, is now offering free online continuing medical education credits for health-care providers on chlamydial infections. The CME for primary-care clinicians is sponsored by the California STD/HIV Prevention Training Center (CA PTC) and the California Chlamydia Action Coalition. (The CA PTC is funded by the Centers for Disease Control and Prevention, and the latter by the California HealthCare Foundation.) This nonprofit public-private collaboration is dedicated to statewide efforts in the prevention and control of sexually transmitted chlamydial infections. For more information, visit the Web site: http://www.stdhivtraining.org .
A new product line for breastfeeding mothers helps them spend more time with baby (or catching up on sleep) and less time cleaning breast pumps and accessories, according to Medela (McHenry, Ill.). Quick Clean Micro-Steam Bags and Anti-Bacterial Wipes provide safe, effective, quick, and convenient clean up.
The Micro-Steam Bags use 2 oz of water and 3 minutes of heat from a microwave oven to steam sterilize (good for 3 hours) all external breast pump components as well as microwave-safe bottles and nipples. Each box contains five reusable bags.
The company's Anti-Bacterial Wipes, the only wipes available that safely clean and disinfect breast-pump components, according to Medela, are used in between pump cleanings. Each package contains 24-premoistened 4 x 6 inch towelettes.
For more information, call 1-800-435-8316 or visit the Web site at http://www.Medela.com .
Birth Control: A Woman's Choice, the latest patient education resource on contraception from the American College of Obstetricians and Gynecologists, is a comprehensive guide to the myriad methods of birth control now available. The book addresses specific birth control options during different phases of a woman's life, ranging from adolescence to perimenopause. It also covers contraception choices for women with medical concerns like high blood pressure, heart disease, diabetes, and lupus. There's also a section on infertility treatment, adoption, and pregnancy termination. For more information, call ACOG at 202-484-3321 or visit http://www.acog.org .
The first FDA-cleared over-the-counter pelvic muscle trainer for urinary incontinence is now available in drugstores nationwide, according to its maker, DesChutes Medical Products, Inc. (Bend, Ore). Known as Myself, the product was previously available by prescription only. The device is said to teach and motivate women to strengthen pelvic muscles to help them achieve better bladder control, recover it more quickly after childbirth, improve vaginal tone, and prevent prolapse.
The kit includes a handheld personal pelvic muscle trainer, a non-latex vaginal sensor (a second sensor for once-a month replacement), instructions, and a travel bag. For more information, about the product, which carries a money-back guarantee, visit http://www.dependonmyself.com .
New Products. Contemporary Ob/Gyn Jul. 1, 2003;48:92-94.