Boston Scientific Corporation has announced that it has received approval from the U.S. Food and Drug Administration to market its Apex™ PTCA(1) Dilatation Catheter. The Apex Catheter is a high-performance pre-dilatation balloon catheter. It has been developed specifically to address physicians’ needs in treating the most challenging atherosclerotic lesions. The Apex Catheter is available for distribution in both Monorail® and Over-The-Wire (OTW) catheter platforms. It represents the next generation of dilatation catheter technology, utilizing a new Bi-Segment™ inner shaft for improved pushability and flexibility.

Spiration, Inc. has made an announcement that its IBV® Valve System has been launched by Olympus in the European markets. The minimally invasive device is used for the treatment of various chronic lung problems. The system has already received the CE Mark for use in the treatment of serious diseases of the lung such as emphysema. Initially, the device will be presented to select physicians of Europe. The system may prove to be a boon for  patients who can not or do not undergo surgical operation. Spiration® will continue with manufacturing while Olympus does the distribution.

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.

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.

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.

Researchers at Cedars-Sinai Medical Center are working on developing a spectral imaging system that could reduce the operating times for infants undergoing surgery for Hirschsprung’s disease, according to a mouse study published in the Journal of Biophotonics. Apart from the diagnostic capabilities, the system could provide an “optical biopsy,” enabling surgeons to determine the exact location of a needed intervention.

Photo by Mat Culpepper

Scientists at SUNY Downstate Medical Center in Brooklyn and Peking University in Beijing have received a U.S. patent for their virtual telemicroscope. This software may be used by offsite pathologists to diagnose diseases in patients located elsewhere. Chinese company Motic has used the patent to create a microscope that scans the slides at different magnifications and the compressed images produced thereafter are emailed to various required locations.

Aerocrine AB has filed a patent infringement suit against Medisoft P.A.E. associated with the marketing and sale of Nitric Oxide (NO) analyser in Germany. Aerocrine AB is seeking an injunction and damages against the Belgian company. Medisoft P.A.E. has recently begun the marketing and sale of the Hypair exhaled NO analyzer in the country.

Abviva Inc. (formerly known as Genesis Bioventures) has been issued a pivotal patent by the United States Patent and Trademark Office for the core technology used in the company’s breast cancer diagnostic test. The Mammastatin Serum Assay (MSA) is a blood test used for the early detection of breast cancer through the identification and measurement of the amount of Mammastatin in women.

Urodynamix Technologies Ltd. has begun the evaluation of its second generation prototype near infrared spectroscopy (NIRS) DRE system. Digital rectal examination (DRE) is the most common screening test for prostate cancer and Urodynamix’s NIRS sensor measures blood flow in the prostate gland during the examination. The device improves physicians’ ability to detect prostate cancer as well as other prostate-related diseases.