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Product Releases



New Pediatric Indication for Topical Corticosteroids

Triax Pharmaceuticals, LLC, announced today the approval of new labeling for Locoid Lipocream (hydrocortisone butyrate, 0.1%), the leading mid-potency corticosteroid brand indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults. The new labeling now includes an indication for topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age to 18 years of age. Topical corticosteroids have become the cornerstone of treatment for a variety of inflammatory dermatoses, including atopic dermatitis, eczema and psoriasis.

Locoid Lipocream is the mid-potency corticosteroid cream with the highest concentration of barrier-enhancing lipids providing the hydrating power of an ointment with the elegance of a cream. The unique combination of 70% lipids dispersed in 30% water provides excellent ability to minimize transepidermal water loss and help restore the skin barrier. Locoid Lipocream forms an occlusive barrier that soothes skin and promotes healing, is propylene glycol-free for patients who can't tolerate stinging, is nonhalogenated, which allows for low risk of potential side effects, contains no known irritants and has a fragrance-free base.


Food Sensitivity Test

For those looking to test at home for food sensitivities, ALCAT offers the ALCAT Test. The ALCAT Test, a simple laboratory blood test, identifies cellular reactions (intolerances, not allergies) to foods, chemicals and various other substances. Eliminating sensitivities may help benefit weight as well as a host of inflammatory-related problems such as irritable bowel, eczema, diabetes and migraines.


Heel Protector

The Posey Company has introduced its new PRO-heeLx Heel Protector. PRO-heeLx is a comfortable foot protector that helps protect against heel ulcers and foot drop. Heel ulcers are the most common facility-acquired pressure ulcer in long-term and acute-care facilities and the second most common pressure ulcer overall. By elevating the foot and separating the heel from the mattress, the PRO-heeLx provides complete heel pressure relief for bedridden and at-risk patients. The soft Orthowick fabric liner in the PRO-heeLx helps minimize heat, moisture, friction and shear on a patient's feet, heels and ankles.

The PRO-heeLx features durable straps that are easily adjustable to help deliver maximum support to the bottom of the foot. The straps maintain their integrity following multiple wash cycles. The lower-support design helps keep the foot in an upright position while the soft comfort-grip interior minimizes friction and shear. The low-friction exterior surface glides easily over bed sheets and blankets, while the Orthowick fabric enables good air circulation and wicks away moisture from the skin. The PRO-heeLx is available in three comfort-fit sizes and also features an optional lateral positioning wedge to help prevent foot drop. The PRO-heeLx functions well with most deep vein thrombosis compression and negative pressure wound therapy devices.


Mighty Wrist Comfort, Tiny Size

IMAK Products Corp. introduces the Le Petit Cushion, a tiny wrist cushion filled with massaging ergoBeads. The Le Petit Cushion is filled with tiny plastic beads that massage your wrist while you work. It's the latest addition to IMAK's popular ergoBeads wrist cushions that make working on a PC or laptop comfortable and therapeutic. The unique petite design, ideal for smaller wrists, is shaped for easy maneuvering of the mouse and also comfortably supports the wrist to eliminate stress, at home or on the go. The washable Le Petit Cushion is latex free and available in new colors: pink, teal, purple and green.


Flexible Thumb Support

The IMAK Products Corp.'s SmartThumb is a flexible stabilizer that offers thumb support and pain relief for everyday activities. The SmartThumb is features two flexible support splints built into the thumb extension, one on each side of the thumb. This design provides comfortable support yet allows full use of the thumb. It also features an elastic inset at the dorsal side and a foam wrist cushion for added support and protection to the hand.

The SmartThumb helps relieve pain and protects the thumbs while the usef does every day activities, including mousing, keyboarding, gaming, using a PDA, crafting and many other activities that may cause painful thumbs. The SmartThumb is made of breathable cotton Lycra for comfortable thumb support all day long.


New Probiotic Formulated for Children

Bifidobacteria play an extraordinary and essential role in children's digestive and immune health. That's why Florajen's founding bacteriologist has developed a new probiotic formula especially for infants and children. Florajen4 Kids has a unique blend of four different strains: Bifidobacterium lactis, and Bifidobacterium bifidum (Bb-12), which produce short chain fatty acids that have an anti-inflammatory effect, as well as Lactobacillus acidophilus and Lactobacillus rhamnosus, proven to inhibit the growth of harmful bacteria in the intestine.

If infants are unable to acquire natural balances of microbial flora at birth or during breastfeeding, or if antibiotics disrupt natural balances, supplementation of good flora may help establish and maintain a healthy gut.


H1N1 Influenza Information in QuickVue Influenza Test Package Insert

Quidel Corporation received Special 510(k) clearance for an update on H1N1 to the Company's QuickVue Influenza A+B test package insert to include reactivity with culture isolates of the 2009 H1N1 Influenza A virus.

Although the QuickVue Influenza A+B test has been shown to detect the 2009 influenza A (H1N1) virus, the performance characteristics of this device with clinical specimens that are positive for the 2009 influenza A (H1N1) virus have not been established. The QuickVue Influenza A+B test kit can distinguish between influenza A and B viruses, but it cannot differentiate influenza subtypes.

This clearance supplements the reactivity with 13 other isolates of seasonal H1N1 influenza viruses currently listed in the package insert. In total, 34 different isolates of human Influenza A, 13 different isolates of human Influenza B, and 24 different isolates from birds and mammals have now been shown to be detectable by the QuickVue Influenza A+B test.


Permanent Contraception System Gains FDA Approval

The U.S. Food an Drug Administration approved the Adiana permanent contraception system by Hologic, Inc.

The Adiana permanent contraception procedure is minimally invasive, requires no incisions and can be performed in outpatient settings using local anesthesia. Patients are normally able to return to work or resume their daily activities within a day, according to Hologic. In contrast, traditional methods of permanent contraception, such as tubal ligation, require more invasive surgical procedures, usually are conducted in a hospital under general anesthesia and typically require several days of recovery.

The Adiana procedure is indicated for women who desire permanent birth control by occlusion of the fallopian tubes. During the Adiana procedure, a slender, flexible instrument is passed through the body's natural openings to deliver a low level of radiofrequency (RF) energy to a small section of each fallopian tube. A tiny, soft insert, about the size of a grain of rice, is then placed in each fallopian tube in the location where the energy was applied. During the 3 months following the procedure, the patient continues to use temporary birth control while new tissue grows in and around the Adiana inserts, eventually blocking the fallopian tubes. At 3 months, a hysterosalpingogram (qn x-ray test) is performed to confirm that the fallopian tubes are completely blocked, and the patient may begin relying on Adiana for permanent contraception.


Test Identifies Breast Cancer Markers

Test Identifies Breast Cancer Markers

Provista Life Sciences LLC has announced a limited national rollout of the BT Test, or Biomarker Translation Test, a new predictive blood test to aid healthcare providers in the early detection of breast cancer. Through a partnership with MedicExams, a national network of healthcare testing facilities, women can now take the BT Test in 27 states nationwide.

The BT Test finds multiple cancer-related proteins in the blood and combines the results with the patient's medical profile to help providers in their efforts to diagnose breast cancer as early as possible. According to Provista, research conducted on the BT Test showed an accuracy rate above 80%.

All of the blood samples are processed at Provista, a CLIA-compliant laboratory in Phoenix. Provista will file private insurance claims on behalf of women who take the BT Test, and women can purchase a test on their own from Provista.

MedicExams will phone to schedule an appointment for the blood draw. Once the sample is collected, MedicExams will make sure the sample and all the necessary paperwork is sent back to Provista for testing. Upon completion of the analysis, the results of the test are then sent to the patient.


Treatment for Facial Skin Discoloration

Treatment for Facial Skin Discoloration

Age Intervention Enlighten by Jan Marini Skin Research is a new composition designed to brighten and encourage the uniform appearance of facial discoloration. 

Uneven skin tones and discoloration can age the look of facial skin. Overly pigmented facial areas caused by melasma, cumulative sun exposure and ethnicity are some of the most common and difficult concerns to treat.

Enlighten contains retinol and two other topical agents combined to address the appearance of facial discoloration. The product is formulated to discourage the production of excess melanin and to assist in resolving the appearance of existing facial discoloration.


Natural Antiviral Product

Natural Antiviral Product

Zeolite-AV is a natural antiviral product by ZEO Health Ltd. Zeolite-AV is new to ZEO Health's line of Zeolite products. Its formula contains two unique all-natural ingredients for use as an antiviral; to absorb toxins, free radicals, and heavy metals from the body; balance the pH in the body; and boost the immune system.


Antimicrobial Keyboard for Healthcare Setting

Antimicrobial Keyboard for Healthcare Setting

Unotron manufactures medical-grade, antimicrobial, true-type keyboards. The SpillSeal technology safely and hermetically seals each key. SpillSeal technology means there are no bacteria-trapping drain holes. All Unotron products are fully submersible and easily disinfected; simply wipe or wash.

Infection control is a large concern in healthcare settings. Unotron's products make it easy to maintain as sterile an environment as possible. Unotron also offers the world's only ScrollSeal washable mice and waterproof smartcard readers.


FDA Approval for Anti-Infective

Hospira, Inc., announced it has received U.S. Food and Drug Administration (FDA) approval for a 10-gram vial of sterile vancomycin hydrochloride, USP, an anti-infective medication. The medication is an effective agent for fighting methicillin-resistant Staphylococcus aureus (MRSA), a common infection that is often resistant to other antibiotics.

Hospira now offers vancomycin in 500-milligram, 750-milligram, and 1-gram dosages as well as 5-gram and 10-gram pharmacy bulk packages. Additionally, Hospira's vancomycin dosages are available in its proprietary ADD-Vantage Drug Delivery System for the 500-milligram and 1-gram presentations.

Hospira's specialty injectable pharmaceuticals include approximately 200 generic injectable drugs in many dosages and formulations. Hospira has approximately 25 generic drugs scheduled to launch in various regions around the world in 2009 and 2010.


Mighty Wrist Comfort, Tiny Size

IMAK Products Corp. introduces the Le Petit Cushion, a tiny wrist cushion with massaging ergoBeads. The Le Petit Cushion is filled with tiny plastic beads that massage your wrist while you work. It's the latest addition to IMAK's popular line of wrist cushions that make working on your PC or laptop comfortable and therapeutic. The unique petite design allows easy maneuvering of the mouse while comfortably supporting your wrist to eliminate stress. The washable Le Petit Cushion is latex free and available in new colors: pink, teal, purple and green.


PRN: Protect, Restore, Nourish

PRN is a unique line of skin care products from Fallene, Ltd., designed to minimize the signs of aging and reduce the effects of cosmetic regimens. This treatment regimen includes PRN Moisturizing Anti-Glycation Cleanser, a gentle cleanser that instantly turns into a rich, creamy foam to lift away oil and impurities. Gentle enough to use every day as needed, it is oil free, moisturizing and mild enough for sensitive skin. The PRN line also includes a protective sunscreen that is free of chemical sunscreen filters and is formulated with Fallene's unique particle sunscreen technology.

PRN Anti-Glycation Moisturizing Gel is designed to restore moisture with sodium hyaluronate and urea to soothe and moisturize the skin. The Anti-Glycation Moisturizing Gel also contains Vitamins A, C, E and B3 to further nourish and revitalize skin. Recommended for use after chemical peels, laser treatments and microdermabrasion, the gel contributes to the successful outcome of aesthetic treatments, according to the company.

The PRN Anti-Oxidant VitaSerum is formulated to nourish mature skin with a blend of vitamins and botanical extracts to help the body synthesize collagen, quench free radicals and remoisturize skin to minimize and reduce wrinkles.


Rapid Test for Avian Influenza A Virus

The U.S. Food and Drug Administration has cleared a new, more rapid influenza A/H5N1 test. The virus is a disease-causing subtype of the avian influenza A virus that can infect humans.

The AVantage A/H5N1 Flu Test, by Arbor Vita, detects influenza A/H5N1 in throat or nose swabs collected from patients who have flu-like symptoms. The test identifies in less than 40 minutes a specific protein (NS1) that indicates the presence of the influenza A/H5N1 virus subtype. Previous tests cleared by the FDA to detect this influenza A virus subtype can take 3 or 4 hours to produce results, according to Arbor Vita.

Influenza A infects both humans and animals. H5N1 is a subtype that is found mostly in birds, although infections have also occurred in humans, mostly in people who have come into contact with the virus through infected poultry. According to the Centers for Disease Control and Prevention, of the few avian influenza viruses that have infected humans, the H5N1 subtype has caused the largest number of detected cases of serious disease and death.

There is a possibility that the influenza A/H5N1 virus subtype could mutate further and spread quickly to humans, causing an influenza pandemic. According to the World Health Organization, there are 412 confirmed human cases of infection from this virus, almost all in Asia and northern Africa. This virus subtype, which can cause life-threatening illness, has not been detected in the Americas.


Product Releases

Web Site for RSV Info
Quidel Corporation, a provider of rapid point-of-care diagnostic tests, launched rsvtesting.com, a Web site dedicated to the latest information about respiratory syncytial virus (RSV), including risk factors, symptoms and rapid diagnostic testing.

RSV is a common virus that causes cold-like symptoms. Almost all children are infected by RSV within their first 2 years of age. Despite the prevalence, RSV is less well-known than influenza. Studies using rapid RSV testing have helped make health care officials more aware of the variability of the RSV season in various geographic areas. Quidel's CLIA-waived QuickVue RSV test supports health care providers in making a faster diagnosis in a single office visit. The Web site features tools such as RSV facts, a glossary and an information sheet.

Phototherapy Cabinet Allows Patients to Stand
Daavlin has received 510K clearance from the FDA to market a new standup UVA1 phototherapy cabinet, the ML24000. This machine is the first approved UVA1 phototherapy device capable of treating all sides the body at once, a feature that dramatically reduces treatment time, according to the company.

The ML24000 uses a combination of high pressure lamps and special filters to produce a pure UVA1 output, with more consistency than fluorescent UVA1 tubes. The ML24000 makes high-dose protocols possible without patient fatigue, and it makes scheduling patients simpler because each treatment is shorter. The device can be installed in spaces half the size of those required for bed devices, and it separates into pieces for assembly in small rooms.

Flu Surveillance Network
Quidel's QuickVue Influenza A+B test is the rapid flu test selected for use in more than 400 health care provider offices participating in the FluSTAR surveillance program during the 2008-09 season. FluSTAR is a comprehensive influenza surveillance network. The FluSTAR system was developed to provide health care professionals and consumers with the most up-to-date information on the spread of the flu during the influenza season.

Data for FluSTAR is gathered from surveillance methods including rapid assay data, laboratory confirmation and clinical diagnosis data. Based on the surveillance methods, a regional as well as a national picture on influenza activity is generated.

Adult Soy Beverage Available
PBM Products, LLC, maker of soy nutrition products, announced that it has introduced A-Soy, a soy nutritional beverage specially formulated for adults who are lactose intolerant, cow's milk allergic or prefer a vegetarian diet. A-Soy, a great-tasting source of balanced nutrition for people older than 10 years, is free of lactose, milk (animal protein), cholesterol, trans fats and gluten.

Certified kosher, A-Soy nutritional drink can be enjoyed as a meal replacement or as a nutritious and filling snack. A-Soy provides complete nutrition that may help reduce heart disease risk, improve diet and promote overall wellness.

Baking Soda Microdermabrasion Machine
Advanced Microderm has upgraded its latest microdermabrasion machine, the DX, into a three-in-one microdermabrasion system that makes use of baking soda's all-natural properties  The versatility of the DX is enhanced by its ability to "turbo charge" the flow of the crystals, allowing for unparalleled efficacy and results, according to the company. Add the company's patented Titan Tips for a crystal free option.

Symptoms Book for Providers
Merck & Co., Inc. has introduced its first-ever reference of patient symptoms, The Merck Manual of Patient Symptoms, to assist pharmacists, nurses, medical students, residents, nurse practitioners and physician assistants in their growing role on the front line of patient care.

Compact enough to carry in a lab coat pocket, the paperback helps health care providers, particularly those who are newcomers to clinical diagnosis, understand and evaluate a wide range of symptoms.

Organized alphabetically, 88 common symptoms - from abdominal pain to wheezing - are addressed in detail. Entries for each symptom begin with a list of possible causes, calling out when possible the most common or dangerous, followed by suggestive findings. Evaluation discussions, red flags and key points are also included.

Evercare Receives Impact Award
Joining the ranks of former President Jimmy Carter and author Maya Angelou, Evercare (a division of UnitedHealth Group) received this year's American Geriatrics Society Foundation for Health in Aging (FHA) Impact Award.

The Impact Award recognizes Evercare for leading the industry with its innovative care model, which provides focused care for nursing home residents as well as patients living independently or with a chronic disease or disability.

The Evercare model uses nurse practitioners and care managers who serve as trusted partners to guide patients through the health care system. These professionals work with physicians, other health care providers, members and their family caregivers to develop and orchestrate personalized care plans to facilitate access to treatments and support services that patients need.

InJoy Videos Offers Parent Education Guides
InJoy Videos, a provider of birth and parenting education, is now offering educators a new product line called See What You Read Web-enhanced parent guides.

See What You Read Web-enhanced guides make complex health topics easy to teach and even easier to understand. Used by educators in the classroom or for one-on-one teaching, See What You Read is an ideal way to teach today's parents with clear writing, instructive photos and its video-rich companion Web site. New parents can continue the learning process at home by watching helpful online video clips from InJoy's award-winning programs at the password-protected, commercial-free See What You Read Web site.

Current See What You Read titles include "Mother and New Baby Care," "Childbirth" and "Better Breastfeeding." The guides, Web site and video clips are also available in Spanish.

New Blood Glucose Monitor From ARKRAY
ARKRAY USA, Inc., the fifth largest blood glucose monitoring company in the world, has received marketing clearance for the GLUCOCARD 01-mini blood glucose monitoring system.

GLUCOCARD 01-mini is the first blood glucose monitoring system specifically designed for patients who want high-end technology and an economical price with interchangeable face plates.

This new system requires no coding, displays results in 7 seconds and requires a tiny 0.3 microliter sample size. It uses the same affordable test strips as the downloadable GLUCOCARD 01 system launched in 2008.

GLUCOCARD 01-mini features premeal and postmeal flags. Most notable, the GLUCOCARD 01-mini is the only system on the market that features interchangeable faceplates so users may personalize the look of their monitoring system. It also features an easy-to-read display.

The GLUCOCARD 01-mini is distinguished by its leading edge design and technology, according to the manufacturer. Premarket studies showed the GLUCOCARD 01-mini to be highly accurate, precise and easy to use.

Antioxidant Benefits of POM Pomegranate Juice
A recent study published in the Journal of Agriculture and Food Chemistry determined that compared to red wine and several juices, POM Wonderful 100% Pomegranate Juice demonstrates the most complete free radical scavenging activity, greater protection of LDL-cholesterol from oxidation and the highest polyphenol content.

The study found that POM tested higher in overall phenolic content and antioxidant activity than red wine, Concord grape juice, blueberry juice and orange juice. POM Wonderful 100% Pomegranate Juice even ranked higher than other beverages recently touted as containing superior levels of antioxidants, such as acai juice and white and green teas.

Unlike all previous studies that only included one test against these other types of beverages, this study conducted a series of seven tests on all the beverages, resulting in a novel and more accurate methodology, according to POM.

Results showed that the antioxidant potency composite index in POM was at least 20% greater than any other beverage included in the study. To determine overall antioxidant content and functionality, each of the polyphenol-rich beverages included in the study were run against four tests for antioxidant potency. In addition, all beverages were tested for their ability to inhibit LDL oxidation and evaluated for total polyphenol content. 

Liquid Vitamin D3 Offers Ease of Use
Carlson Laboratories has introduced liquid vitamin D3 drops. Carlson Ddrops is pure, natural liquid vitamin D3 available in three concentrated sizes: Baby Ddrops 400 IU, Ddrops 1,000 IU and Ddrops 2,000 IU. These tasteless drops offer a convenient way to receive the health benefits of vitamin D3.

One drop can be added to a meal to obtain the desired dose. Carlson Ddrops are concentrated into vitamin D's purest form, providing tasteless and powerful vitamin D in each drop.


Product Releases

Comfortable Skin Testing Device
HollisterStier has created the ComforTen Multiple Skin Test System, its newest allergy testing device. The device features 10 surgical steel 1.2-mm lancet tips, which create minimal skin trauma for comfortable allergy testing. ComforTen causes little or no trauma at the negative control site for easy reading of skin test reactions.

The ComforTen system includes trays with three optional-use spacers that increase the number of tests that can be completed between fillings. The trays are also supplied with self-adhesive labels, allowing for customized tray labeling.

When used as directed, the ComforTen device with depth control guards will produce 10 reproducible skin tests resulting in well-defined reactions. The device is equipped with directional indicators to help ensure the proper orientation and application.

Nasal Irrigation for Sinus Cleansing
Health care providers are beginning to recommend nasal irrigation before prescribing antibiotics for patients with sinus symptoms. Saline nasal irrigation kits, such as those created by B.F. Ascher & Company, can be found in the cough and cold aisle at pharmacies. They come packaged with either the neti pot or squeeze bottle application device, premeasured salt packets and detailed instructions on proper usage.

Saltwater nasal irrigation consists of warm water and a premeasured amount of salt combined inside a squeeze bottle or neti pot. Once the warm saltwater solution is mixed inside the squeeze bottle or neti pot, the applicator is pressed into the nostril. The user tilts his or her head at an angle and squeezes the bottle or tips the neti pot. The saltwater solution enters the nose through one nostril and exits the other, cleansing the sinuses. The user then repeats the process in the other nostril.


Reduce Eye Strain With Eye Pillow
IMAK's Eye Pillow helps relieve the symptoms of computer vision syndrome (CVS). People who use computers daily could develop CVS. Recommended treatment and prevention include a cold compress applied to the eyes for 5 to 10 minutes as needed.

The Eye Pillow can be chilled in the freezer or refrigerator to provide a rest to eyes by holding the cold and blocking out light. Unlike other eye masks, IMAK's Eye Pillow features sewn-in darts to leave room for lashes and is filled with tiny, smooth plastic beads called ergoBeads, which spread a soothing, gentle weight around the eyes.

Automated Patient Messaging System
PhoneTree Patient Messaging helps health care providers to engage patients while improving the bottom line. The PhoneTree system helps create fewer no-shows and a return on investment that will generate new revenue, according to the company. For any size practice, PhoneTree Patient Messaging automatically contacts patients by any combination of voice, e-mail or text messaging about upcoming appointments, lab results, preregistration, past-due accounts and more.


Effective System for Overactive Bladder
The Urgent PC Neuromodulation System from Uroplasty provides a nondrug, minimally invasive method to treat symptoms of overactive bladder (OAB) via percutaneous tibial nerve stimulation (PTNS). Therapy is delivered via a thin needle placed through the skin in the inner ankle near the tibial nerve and connected to the handheld, battery-operated stimulator. Patients remain clothed and are seated in a comfortable position during 30-minute sessions, which can be performed by nurse practitioners in an office setting.

Urgent PC is designed to reduce sensations of urgency, episodes of urge incontinence and frequency of urination. No significant product-related adverse events or side effects have been reported, according to the company. PTNS is a particularly attractive treatment option for patients who are either refractory to drug therapy or experience intolerable side effects. The therapy can be used as part of a comprehensive approach to treating patients with bothersome symptoms of OAB.


Neuropathy Cream Provides Pain Relief
Diabetic neuropathy occurs in many patients with long-term diabetes and is implicated in nontraumatic amputations. Zostrix Neuropathy cream can be used alone or as a complement to systemic pain therapeutics to effectively help relieve diabetic neuropathy pain.

Zosrix Neuropathy is made with topical purified natural capsaicin (0.25%), and the product's unique formulation improves the tolerance of high-strength capsaicin because the patented cream base includes lidocaine.

The formulation is effective with continued use for the treatment of localized neuropathic pain, and it has a low risk of systemic side effects, adverse events or drug interactions, according to the company.

Zostrix Neuropathy is available in 2-ounce tubes and can be found near the diabetic testing supplies at most drug stores nationwide.

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