The latest in medical products for obstetrics and gynecology.
FDA clearance for laptop ultrasound system
Direct Medical Systems, LLC has received FDA clearance to market its InnovaSound USB Ultrasound System, featuring a complete ultrasound system in each probe and said to be more affordably priced than competitors. Clinicians download the software to the nearest computer, plug in the USB cable of the handheld unit, and scan. Computer requirements are one USB 2.0 and either Windows XP or Vista with at least a 1 MHz processor and 512 MB of memory.
Direct Medical Systems says it's also developing an affordable and easy-to-use 3-D imaging module to be integrated into its probe. For more information, visit the company Web site at http://www.dmsww.com/ or firstname.lastname@example.org.
The light pipe on the molded acrylic specula of the new 590 Series is now said to eliminate glare-back and project light forward where it's needed most. Wider handles improve maneuverability during pelvic exams and the unit has a new automatic on/off switch. For more information, call 800-535-6663 or visit the Web site at http://www.welchallyn.com/.
Lower-dose hormone therapy option
In a clinical trial, the most frequently reported adverse events were back pain, headache, extremity pain, nausea, diarrhea, nasopharyngitis, endometrial thickening, and vaginal hemorrhage. For more information, call 800-535-6663 or visit the Web site at http://www.activella.com/.
FDA approves prescription botanical to treat HPV-related warts
The FDA has approved its first prescription botanical in some 50 years, a green tea extract applied topically called Polyphenon E, 15%, to treat external genital and perianal warts caused by some strains of the human papillomavirus. Made by MediGene AG, a German biotech company, it will be marketed to obstetrician/gynecologists by Bradley Pharmaceuticals, Inc. (Fairfield, NJ.). The company says the ointment's active ingredient is a mixture of catechins extracted from green tea leaves. In phase 3 clinical trials of 1,000 or more participants, the ointment was quite effective against external genital and perianal warts caused by certain strains of HPV, MediGene says. The product should be available in the second half of 2007. For more information, visit the Web site at http://www.bradpharm.com/.