FDA OKs Pain Management Device
The FDA has approved Empi's (Saint Paul, MN) Select Transcutaneous Electrical Nerve Stimulation (TENS) device for the relief of chronic, arthritic, and postsurgical pain. The portable device can be used at home or away from home, and features preset treatment programs that make it easy to use.
The noninvasive, nonsystemic device ensures that patients receive the appropriate electrotherapy treatment specific to their condition and treatment site. It uses a patented SMP waveform that delivers maximum pain relief through the use of both endorphin release and gate control pathways.
Handheld Wireless Blood Analysis System Approved
Epocal (Ottawa, Canada) has received FDA approval for its point-of-care blood analysis system, Epoc. Epoc rapidly performs a panel of the most critical acute care tests at the patient's bedside. The device measures pH, Paco2, PaO2, Na, K, iCa, and Hct and calculates HCO3, TCO2, base excess, SaO2, and Hb.
This system includes blood test cards on the company's proprietary adaptation of smart card technology and low-cost card readers that are wirelessly connected to hand-held PDAs (the host computer).
The complete test record is available through the host computer interface and is wirelessly transmissible for further reporting, analysis, and data archiving.
New Device Treats Individual Acne Pimples
The FDA approved DermaCare, Inc.'s (San Francisco, CA) ThermaClear for the treatment of individual pimples in persons with mild-to-moderate inflammatory acne. The portable, hand-held, battery-operated device is similar to laser treatment technology used by dermatologists as it delivers a short thermal pulse to the pimple, neutralizing underlying bacteria.
The device has been shown in a clinical trial to accelerate healing time, clear pimples in less than half the time compared with those left untreated-often within 2 to 4 days. Unlike topical medications, use of the device does not overdry or irritate the skin.
ThermaClear uses a controlled thermal pulse to treat each pimple called HEAT-Heat Enabled Acne Treatment. The device can be applied to each pimple as soon as it is noticed.
Thermal Pulse Technology delivers a short pulse of healing thermal energy that effectively and safely penetrates below the skin and neutralizes the underlying bacteria that causes breakouts. Users feel a tingle or "zap" when using the device.
Surgical Patch Recall More Serious
The FDA notified healthcare practitioners that CR Bard's (Cranston, RI) Composix Kugel Mesh Large Surgical Patch, already under recall, could cause death or serious health problems.
Coil rings in the Composix Kugel Mesh Patches, used to repair hernias, could break under stress during placement, causing abdominal pain or bowel perforation, according to the FDA and the company.
Customers should stop using the recalled product and return unused units to the company. The recall, first announced in March 2006 and expanded recently, now has Class 1 status because of its serious nature.
First Test to Screen for Chagas Disease
Ortho-Clinical Diagnostics, Inc.'s new test to screen blood donors for the parasite that causes Chagas disease is now FDA approved. The Ortho T. cruzi ELISA Test System detects antibodies to the Trypanosoma cruzi parasite, and is the first such test to be approved.
As many as 11 million people are currently infected by T. cruzi, most commonly in Mexico and Central and South America. The infection is usually acquired from the bite of an infected insect but can be transmitted from blood transfusions or organ transplants.
Studies show that the test is accurate 99% or more of the time with extremely few false positives. The FDA notes that in addition to screening blood donors, the test is also intended for use in screening plasma and serum samples from organ, cell, and tissue donors.