Cayenne Medical Inc. has received FDA clearance for the iFix(TM) Interference Screw System for use in bone-tendon-bone ACL reconstruction procedures. These are the first FDA approved screws to hit the market that are made from polyetheretherketone (PEEK) plastic, which is radiolucent and highly biocompatible and has superior biomechanical strength. PEEK is a completely bio-inert material and, hence, screws made from this material do not result in foreign body reactions in patients.

Biomedical engineering researchers at the Queensland University of Technology (QUT) are working on developing a computer modeling program that would allow surgeons to simulate scoliosis surgery. This would enable surgeons to determine the most effective procedure before entering the operation theater. Professor Clayton Adam, a member of QUT’s Institute of Health and Biomedical Innovation (IHBI), said, “Spine surgery is one of the most complicated and painstaking operations because surgeons cannot afford to damage the delicate spinal cord.”

Diazyme Laboratories has received a 510(k) clearance from the FDA to market its Cystatin C Assay Kit for verifying Cystatin C in serum and plasma samples for the early detection of chronic kidney disease. The Cystatin assay is highly accurate and precise and offers an extended reportable range of 0.47 to over 8 mg/L, reducing the need for repeating tests on elevated samples.

Barr Pharmaceuticals Inc. has received FDA approval for pramipexole dihydrochloride in 0.125mg, 0.25mg, 0.5mg, 1mg and 1.5mg strengths. This drug is the generic version of Boehringer Ingelheim Pharmaceuticals Inc.’s Mirapex tablets, used for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. Barr is currently challenging a patent protecting Mirapex and has agreed not to launch its generic Mirapex until 90 days following the conclusion of the presentation of evidence in the district court trial, a favorable judgment is entered by the district court or July 14, whichever comes earlier.

Light BioScience LLC has received a 510(k) over-the-counter (OTC) clearance from the FDA for its GentleWaves LED Photomodulation technology. The LED (light emitting diode) based, anti-wrinkle treatment is already being used by physicians to reduce the appearance of fine lines and wrinkles. The company claims that the technology helps to stimulate collagen production as well as to slow down collagen breakdown. Light BioScience can now develop a device that can be sold without a prescription.

Arbios Systems Inc. has received conditional approval from the FDA of an Investigational Device Exemption (“IDE”) to commence the pivotal clinical trial for SEPET(TM). SEPET is an extracorporeal (outside the body) device that assists the liver to purify blood of chronically ill patients suffering from acute liver failure. Arbios is still required by the FDA to furnish some information related to the device before it can receive final approval.

Boston Scientific Corp. has received FDA approval for two implantable defibrillators, CONFIENT and LIVIAN, and an upgraded LATITUDE Patient Management System. The CONFIENT ICD (implantable cardioverter defibrillator) helps protect patients at risk of sudden cardiac death. The LIVIAN CRT-D (cardiac resynchronization therapy defibrillator) provides cardiac resynchronization and defibrillation therapies in a single device. The upgraded Latitude Patient Management System enables physicians to remotely monitor patients.

Orchid Chemicals & Pharmaceuticals Ltd. has received FDA approval for its Abbreviated New Drug Application (ANDA) for Granisetron Hydrochloride tablets in the 1-mg strength. Granisetron Hydrochloride tablets are a generic form of Roche’s Kytril drug, used to treat nausea induced by chemotherapy and radiation therapies. Orchid is the first Indian company to get an FDA approval for a non-antibiotic product.

Canadian medical device company ART (Advanced Research Technologies Inc.) announced the first sale of its SoftScan optical breast imaging system. The device was purchased by Sunnybrook Research Institute, where Dr. Gregory Czarnota would conduct a pilot study to determine the SoftScan system’s role in monitoring response to breast cancer treatment, particularly neoadjuvant therapies. SoftScan helps to monitor the response to breast cancer treatment by identifying tumors by their metabolic signatures.

Rituxan (rituximab), the blockbuster cancer drug sold by Genentech Inc. and Biogen-Idec, reduced brain lesions and their relapse in multiple sclerosis patients, according to a study published in the New England Journal of Medicine. The UCSF researchers, led by Stephen Hauser, observed 104 patients for a 48-week period. The study showed that only 20% of the patients who received Rituxan suffered from a relapse, as compared to 40% of those who received placebo.