New Products

March 1, 2003



 

NEW PRODUCTS

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U/S that's practically palm-sized

Now there's an all-digital ultrasound platform that's barely bigger than a PDA: SonoSite's 3-lb iLook series. Designed as a hand-carried device, the product aims to cut costs while helping physicians with on-the-spot diagnosis. Having received 510 (k) approval, SonoSite is initially offering two iLook systems for hospital use: iLook 15 for quick-look diagnostic areas like the E/R and surgical recovery, and iLook 265 for clinicians who perform vascular access procedures. Both products can be used alone or to supplement other SonoSite U/S imaging products. The iLook systems have a single fixed transducer, can use battery power or active current, and feature a PDA-like touch screen as the user interface. Price ranges between $12,500 and $15,500. For more information, visit http://www.sonosite.com .

Breast Ca management tests given FDA-marketing clearance

ChromaVision Medical Systems, the maker of the digital microscope system known as Automated Cellular Imaging System (ACIS), has received FDA clearance to use its ACIS system to perform two breast cancer management tests. The ACIS applications detect and quantify the presence of estrogen and progesterone receptors to guide physicians in individualizing treatment for breast cancer patients. ACIS is indicated for use as an aide in the management, prognosis, and prediction of therapy outcomes of breast cancer. According to the manufacturer, the ACIS combines proprietary, color-based imaging technology with automated, digital microscopy to increase detection sensitivity more than 300% over manual testing methods. For more information, visit http://www.chromavision.com .

Putting a PDR on your PDA

One of the latest electronic products from the Physicians' Desk Reference is a free download of the mobilePDR for your personal digital assistant. Installation of this portable product—a version of the PDR—is available at no cost to ob/gyns, NPs, and others who qualify. The mobilePDR is produced by Thomson Healthcare, the parent company of Medical Economics, Contemporary OB/GYN, and the PDR. Easy-to-install versions of the product are available for PDAs that use either the Palm or Windows CE operating system. Installation does require an active Internet connection, however.

Each entry covers a drug's indications, contraindications, and more, but for complete data, is also cross-referenced to its location in the PDR's print version. For more information—and to download your free mobile PDR—visit http://www.pdr.net .

 

FDA approves drug that fights osteoporosis by stimulating bone growth

The FDA has approved FORTEO (teriparatide [rDNA origin] injection) for treating osteoporosis in postmenopausal women who are at high risk for a fracture. The drug is the first in a new class of bone formation agents that work mainly to stimulate new bone by increasing the number and action of osteoblasts. Previously, the only approved osteoporosis treatments were antiresorptives, which work by slowing down bone loss. Made by recombinant technology, the drug is a parathyroid hormone (PTH) fraction. The agency's approval was based on 24 clinical trials enrolling more than 2,800 postmenopausal women and men with osteoporosis. Pivotal Phase III clinical trial data in 2001 showed that FORTEO stimulated new bone formation, lowered the risk of spinal fractures, and increased bone mineral density when compared with placebo in postmenopausal women with osteoporosis during 19 months of treatment on average.

FORTEO is self-injected once daily via a disposable pen device that can be used for up to 28 days. Because of a black box warning about osteosarcoma in rats during preclinical testing, it should be prescribed only to patients for whom potential benefits outweigh risks.

For more information, visit http//www.lilly.com .

 

Pregnancy book for dads

A new 288-page paperback for expectant fathers aims to give practical advice, encourage supportiveness, and get fathers more involved with their baby-to-be long before it arrives. The seventh in a series of books on pregnancy and childbirth by ob/gyn author Glade B. Curtis, MD, and co-writer Judith Schuler, "Your Pregnancy for the Father-to-Be" (Perseus Publishing, $13.95) tells how a normal pregnancy affects both parents. Topics from financial preparedness to prenatal tests are included as the authors set out to cover, "everything dads need to know about pregnancy, childbirth, and getting ready for a new baby." For more information, visit the publisher's Web site at http://www.perseuspublishing.com .

Resistance exerciser for fighting incontinence

The FDA has given 510(k) marketing approval to GyneFlex, a physician-created exerciser for strengthening pelvic floor muscles as a way to treat incontinence without surgery. The product comes in three flex strengths. "Light" is intended for women with severe incontinence, atrophy, or those who've had three or more vaginal deliveries. "Regular" is for women with moderate incontinence or those who've had up to two vaginal deliveries, while "Firm" is for women younger than 27 who've never had children. For more information on the product and pelvic floor muscle health, visit: http://www.gyneflex.com .

 

Illuminating small surgical cavities

The new narrower LightMat Thin—the latest in a range of cool surgical lighting products—is thin enough to light up small, tight cavities found in minimally open nonlaparoscopic surgeries. Designed to improve visibility during procedures, the disposable product comes in two versions. The flexible, acrylic fiber optic panel can fit onto existing retractors, according to the manufacturer, Lumitex, Inc. (Strongsville, Ohio.) A second version actually functions as a retractor. Both are single-use only. For more information, call 1-800-969-5483 or visit the Web site at http://www.lightmat.com .

 

New Products. Contemporary Ob/Gyn 2003;3:123-124.