Digital Mammography System Approved
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The FDA approved the LORAD Digital Breast Imaging (LDBI) full field digital mammography system. The system generates digital mammographic images for screening and diagnosing breast cancer. Manufactured by Hologic Inc., the system is intended for use in the same clinical applications as traditional screen-film mammographic systems. For more information, visit http://www.loradmedical.com.
Computerized Drug Dosing System Introduced
RxFiles Corporation has introduced the Intelligent Dosing System (IDS), a software system that helps clinicians prescribe the most effective drug dose for patients. The tool determines the dose response curve or "fit" of drugs and helps individualize the next dose.
IDS contains three software applications designed for a handheld, personal digital assistant or computer. The three applications include DoseRx (a "next" dose calculator), InterchangeRx (a therapeutic interchanger that switches patients between drugs, from brand names to generics, or between drug classes), and PracticePrescribeRx (a graded prescriber training simulator) to introduce new drugs, refresh experience with seldom-used drugs, and document proficiency among prescribers.
IDS provides a precision and accuracy rate of 90% to 97%, according to the manufacturer. The manufacturer defines accuracy as the exact dose needed for the patient to reach a specific response or marker on the next dose. For more information, visit http://www.rxfiles.net or call 941-483-3784.
Blocking Injection Pain
Bionix Development Corporation has introduced ShotBlocker, a plastic, single-use device that blocks the pain associated with injections. The ShotBlocker features a number of short, blunt skin contact points on its underside. The clinician places the device on the patient's skin and administers the injection through Shotblocker's central opening.
ShotBlocker uses the gate control theory of pain management: When a gating mechanism in the spinal cord is open, small nerve fibers transfer pain signals to the brain. Simultaneous stimulation of large-diameter nerve fibers, which respond to touch, close the gate
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ShotBlocker costs less than $1 each and comes in boxes of 25 and 100. More information is available at 1-800-551-7096 or http://www.bionix.com.
Pocket-Sized ECG Machine Approved
The FDA approved the Pocketview ECG, a portable, pocket-sized version of an electrocardiographic (ECG) machine. The device, made by MicroMedical Industries, contains 12 leads and performs the same function as a standard ECG machine.
The device displays results or you may transmit the data (using software) to a computer. The device can store numerous ECGs, displaying up to four separate results for simultaneous comparison.
Identify Breast Cancer Risk Factors
Nastech Pharmaceutical has introduced the Mammary Aspiration Specimen Cytology Test (MASCT), a noninvasive device for the early detection of breast cancer. The MASCT detects atypical changes in cells lining the milk ducts.
In a clinical trial of healthy, nonpregnant, nonlactating premenopausal women (ages 30 to 49), the MASCT's results correlated with mammogram and clinical breast examination results. In addition, the MASCT successfully collected diagnostic amounts of nipple aspirate fluid for a conclusive cytological examination. For more information, visit http://www.nastech.com.
New Lab Test for Group B Strep
The FDA has approved the IDI-Strep B test, a new lab test to detect Group B Streptococcus in pregnant women. The test is a product of Infectio Diagnostics (Quebec City, Canada). It uses a Cepheid Smart Cycler instrument on a swab sample taken from the vagina and rectum, and offers results in 1 hour in facilities that provide round-the-clock testing. The standard culturing method takes 18-48 hours.
The test is particularly useful for women who start labor early or for those who have not received prenatal care. The FDA cleared the IDI-Strep B test based on clinical studies of 802 women at five medical centers in the United States and Canada; the test detected approximately 94% of Group B Strep in pregnant women. According to the FDA, because the IDI-Strep B test is at least 85% sensitive compared to culture methods, it can be used instead of standard culture methods.
Reduce Pain with Skin Refrigerant
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The topical skin refrigerant, Ethyl Chloride, received FDA approval to minimize pain associated with injections, minor surgery, bruises, contusions, swelling, and minor sprains. A 4 to 10 second spray of the product provides an instant topical anesthesia. For more information, visit http://www.gebauerco.com or call 1-800-321-9348.
Device Treats Fibroids
A device that treats uterine fibroids by shrinking them as opposed to surgical removal has recently become FDA-approved. The device, Embosphere Microspheres, is a product of BioSphere Medical(Rockland, Mass). It is intended to treat symptomatic uterine fibroids in women who no longer intend to become pregnant and is used in uterine artery embolization (UAE).
The safety and effectiveness of the device were shown in a clinical study of 132 women treated with Embosphere Microspheres at seven U.S. medical centers. After 6 months, 65% had experienced a 50% or more reduction in bleeding. All had significant pain requiring intravenous or oral pain medication for 1 to 2 days following the procedure, and in 4 cases, pain persisted beyond that period. Six percent of women experienced an allergic reaction during or following the procedure that was generally judged to be unrelated to the embolic particles.
Nine percent experienced either no improvement or increasingly worse bleeding following UAE. The FDA notes that UAE is associated with other, more serious risks.
Biosphere Medical will continue to track patients for at least 3 years to determine whether and how often the fibroids will return.