Archive for the 'Clinical Chemistry' Category

Echo Therapeutics Announces Successful Completion Of Clinical Trial For Prelude(TM) SkinPrep System And 4 percent Lidocaine Cream

Echo TherapeuticsEcho Therapeutics, Inc. has announced the completion of a clinical study of Prelude. This clinical study was designed to evaluate the ability of Prelude to ablate the skin prior to the application of OTC 4% lidocaine cream for faster-acting local dermal anesthesia. As a result of the clinical trial, Echo now expects the submission of a 510(k) premarket notification to the United States Food and Drug Administration (FDA) in the near future.

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FDA okays SpectraScience WavSTAT System

SpectraScienceSpectraScience Inc has received FDA approval for the WavSTAT System. The system is the first commercially available product that incorporates this innovative technology for clinical use. WavSTAT is indicated for use as an adjunct to lower gastrointestinal (GI) endoscopy and is intended for the evaluation of polyps less than one centimeter in diameter, which the physician has not already elected to remove.

FDA approves JBAIDS testing device

JBAIDSThe FDA has approved a portable polymerase chain reaction (PCR) testing device, which can be used by military doctors to diagnose novel H1N1 flu infections in troops stationed overseas. The device, called (Joint Biological Agent Identification and Diagnostic System), is a rugged, suitcase-sized instrument that can run PCR-based molecular diagnostic tests. It has been under development for several years by a consortium of military health research centers, the CDC and academic medical laboratories.

New non-surgical test developed for endometriosis

endometriosisScientists have developed a simple test for endometriosis, a painful pelvic condition that can cause infertility in women. Researchers from Australia and Jordan have found that a biopsy of the lining of the uterus can be taken via the cervix without anesthetic. The new test could replace laparoscopy, a surgical procedure performed under general anesthetic in which a small telescope is passed through the belly button to gain access to the pelvis. Nemone Warner, of Endometriosis UK, said “Women will benefit from earlier diagnosis without the risk of surgical complications.”

Urine tests may help in personalized drug prescriptions

PfizerUnder a new approach pioneered by British scientists from Imperial College London and Pfizer, patients who need drug treatment could be given individually tailored prescriptions based on the results of simple urine tests. New research has shown that chemical signatures predicting how a patient will respond to particular drugs can be detected in urine, paving the way for the development of tests to help doctors prescribe more safely and effectively.