• Cayenne Medical (Scottsdale, Arizona) said it has received FDA market clearance for its iFix Interference Screw System for use in bone-tendon-bone ACL reconstruction procedures. The company said the iFix Interference Screws are the first FDA-approved screws on the market that are manufactured using polyetheretherketone, a form of plastic that is highly biocompatible, biomechanically strong and radiolucent. The iFix system was developed to provide surgeons with a screw that has what Cayenne said is “a superior biomechanical strength compared to bioabsorbable and biocomposite interference screws, and one that is superior to metallic screws, which interfere with post-op imaging.”

• EnteroMedics (St. Paul, Minnesota) said that the FDA has granted approval for the expansion of its clinical trial, known as the EMPOWER study, from 220 patients to 300 patients. Full enrollment in the EMPOWER study is expected in the first half of 2008, consistent with previous projections, despite expansion of the study. The EMPOWER study is a randomized, double-blind, placebo-controlled study being conducted to evaluate the safety and effectiveness of investigational VBLOC vagal blocking therapy using the Maestro system in obese patients. VBLOC Therapy is designed to empower weight loss by promoting earlier feelings of fullness and reduced hunger while minimizing the side effects and complications associated with existing surgical options and preserving the individual’s normal anatomy. EnteroMedics makes devices using neuroblocking technology to treat obesity and other gastrointestinal disorders.

• Iris International (Chatsworth, California) said that its Iris Molecular Diagnostics (IMD) group has successfully completed a retrospective study of stored leftover serum of 85 post-prostatectomy patients, men who had their prostate removed due to prostate cancer, using its investigational NADiA (Nucleic Acid Detection ImmunoAssay) PSA Assay. In this study, the NADiA PSA Assay detected levels and increasing levels of PSA that were previously undetectable using conventional ultra sensitive assays, thus potentially enabling the detection of biochemical recurrence (BCR) an average 2-1/2 years earlier than with the most sensitive commercially available tPSA assays. Iris International makes medical devices, diagnostic systems and consumables.