• Cardo Medical (Los Angeles) reported the first successful implantation of the Align 360 Total Knee system. Cardo Medical recently commercialized its Total Knee system as an adjunct to its Align 360 Knee platform which consists of its clinically proven Uni-Compartmental Knee system and its Patello-Femoral Knee system. All three "A La Carte Knee Remodeling" systems within the Align 360 Knee platform are designed to be highly bone conserving and feature a unique modular approach and common instrumentation system with a revolutionary concept designed to deliver simplified, reproducible surgical outcomes.

• Given Imaging (Yoqneam, Israel) said the FDA recently cleared its PillCam SB video capsules and Agile patency capsules for use in patients two years of age and older. Previously PillCam SB and Agile were indicated for children 10 years and older. PillCam SB is cleared for the visualization of the small bowel mucosa and may be used as a tool for the detection of abnormalities of the small bowel. PillCam capsule endoscopes are ingestible video capsules that enable physicians to visualize distinct portions of the GI tract. Patient friendly in nature, PillCam endoscopy typically is used on an outpatient basis and has been clinically validated, as evidenced by more than 1,000 peer-reviewed publications.

• Incept BioSystems (Ann Arbor, Michigan) said that it has initiated the first U.S. human clinical trial of its SMART Embryo Culture System. The microscale SMART technology platform is designed to improve the in vitro manipulation, performance, and viability of embryos for the treatment of patients undergoing in vitro fertilization (IVF). The study will assess the SMART system's capacity to safely enhance morphological embryo development and survival rates at day three of development, in comparison to the existing practice of growing embryos in a conventional culture dish. Incept says its microfluidic system brings embryologists a significant step closer to natural conditions by providing a continuous, refreshable culture microenvironment while using industry-standard IVF culture medium. It is believed that this dynamic environment may provide a beneficial physical stimulus to the embryos in addition to replenishing the embryos with fresh medium while removing metabolized waste products.

• IVAX Diagnostics (Miami) said that its U.S. subsidiary, Diamedix, has filed a 510(k) premarket submission with the FDAfor its next -generation fully automated Enzyme-linked Immunosorbent Assay (ELISA) system for autoimmune and infectious disease testing, named the Mago 4S. IVAX Diagnostics believes the new instrumentation will provide a flexible, efficient and cost-effective solution to today's high-performance laboratory demands.

• Life Spine (Hoffman Estates, Illinois) received FDA marketing approval to the Sentinel Occipito-Cervico-Thoracic (OCT) System. The Sentinel OCT System provides rigid stabilization and promotes fusion from the occiput to thoracic spine, and features streamlined implants and instruments to address complicated procedures. Polyaxial screws are available in multiple diameters and lengths, and offer a generous cone angulation, which simplifies alignment with the rod and minimizes rod contouring. The addition of the Sentinel OCT System to the current broad product offering is a watershed event providing the ability to offer surgeons a full range of solutions to address spinal pathologies from the occiput to the sacrum.