Archive for September, 2008

FDA approves DizzyFIX

Canadian company Clearwater’s DizzyFIX has been cleared by the U.S. Food and Drug Administration. The DizzyFIX is a low-cost visual-feedback device which easily attaches to a hat. Used as a guide to the Epley maneuvers it can be an effective treatment for the most common cause of vertigo, Benign Paroxysmal Positional Vertigo (BPPV). The device that has been developed by ENT specialists emerges as an alternative to the drug therapy that aims at simply masking the symptoms.

Olympus introduces Enzymatic Creatinine assay

Olympus has come up with  its new Enzymatic Creatinine assay, that can be used across the range of Olympus diagnostic analyzers. Developed to determine the quantity of creatinine in human urine, serum and plasma, the novel assay makes use of an enzymatic method to attain greater precision, interfering lesser and lesser with antibiotics and bilirubin. It compliments the Jaffe technique, currently in use, measuring creatinine more exactly for specific cases in which the potential interference exists from diabetes, liver failure, renal failure and jaundice.

Gyrus ACMI launches Smith™ Digital IPN

Gyrus ACMI, an Olympus Company, has launched the Smith™ Digital Percutaneous Nephroscope (IPN). The device uses an ultra-miniature 1 mm complementary metal oxide semi-conductor (CMOS) imaging sensor. Now, one can do away with bulky external video accessories. A single connection for true “plug & play” digital technology has reduced the number of components. This will not only make it simple, but also bring down maintenance and ownership costs of the device.  The Smith™ Digital Nephroscope is much lighter as compared to the traditional fiber optic percutaneous nephroscopes because of its integrated digital technology, which makes it beneficial for surgeons.

Medtronic, Inc launches Discyphor Direct™ Catheter System

Medtronic, Inc.’s Discyphor Direct™ Catheter System is now available in United States. Doctors use the second-generation catheter system to get more information on detecting the disc that causes discogenic low back pain. The system uses the company’s innovative Functional Anaesthetic Discography™ Procedure. Each disc is anesthetized individually for diagnosis of the disc that causes pain. Spine surgeons often use the procedure’s benefit in the form of diagnostic results to determine the best treatment for patients.

FDA classifies Physio Control’s AED correction as a Class I action

The U.S. Food and Drug Administration has classified Physio-Control, Inc.’s medical device recall of 249 fully automatic LIFEPAK CR Plus automated external defibrillators (AEDs) as a Class I action. Some of these devices manufactured between May 2004 and April 2007 are configured incorrectly. The shock button can not be located as it is covered in the fully automated device. This may lead to a delay in delivery of therapy as a patient complained. Physio-Control has notified replacement devices at no charge to all the affected customers.

FDA Approves two ANDAs for for Dexamethasone Sodium Phosphate Injection

The U.S. Food and Drug Administration has announced the approval of Akorn-Strides’ two ANDAs for Dexamethasone Sodium Phosphate Injection USP, 4 mg (base)/mL in 1mL, 5 mL, and 30 mL vials, and Dexamethasone Sodium Phosphate Injection USP, 10 mg (base)/mL in 10 mL vials. Akorn-Strides, LLC, a Joint Venture that was formed in 2005 by Akorn, Inc. and Strides Arcolab Limited aims to develop liquid, lyophilized and dry powder formulations of generic injectable products targeting a number of ditherapeutic markets with a major focus on anti-infectives, analgesics and CNS drugs. The injection is used in the treatment of endocrine disorders, arthritis, blood disorders, dermatologic diseases, severe allergic reactions, eye diseases, certain cancers, gastrointestinal diseases and respiratory diseases.

Australia gets new drug for type two diabetes

A new oral medication for type two diabetes is now available in Australia. The drug, Januvia, is designed to manage the nation’s fastest growing chronic disease in a better way, with which millions of Australians are suffering. Given a single dose a day, “Januvia boosts the effect of a natural body process called the incretin system”, Sydney’s Royal North Shore Hospital, Greg Fulcher said in a statement. Incretins are intestinal hormones that are released after the intake of food. They are essential for regulating blood glucose. Type two diabetes patients have impaired incretins. The drug, the first ever oral medication for the purpose, is a Merck & Co product.