• Amedica (Salt Lake City) said that the FDA has granted clearance to its Valeo pedicle screw system, a low profile and modular pedicle screw system using features aimed at allowing surgeons greater flexibility in the positioning of these spinal implants. The Valeo system is intended for non-cervical pedicle fixation from the T1 through L5 vertebral bodies of the spine as an adjunct to fusion. The implant and related instruments are designed to facilitate greater modularity and to better suit patient anatomy and achieve a consistent supplemental fixation outcome for many indications including degenerative disc disease, spinal stenosis and failed prior spine fusion surgery. Amedica is an orthopedic implants company focused on silicon nitride ceramic technologies.

• Immunicon (Huntingdon Valley, Pennsylvania) said that it received FDA clearance for its CellSearch circulating tumor cell kit as an aid in the monitoring of patients with metastatic colorectal cancer. The CellSearch test was originally cleared in 2004 for in vitro diagnostic use in patients with metastatic breast cancer. Serial testing for circulating tumor cell (CTC) count should be used in conjunction with other clinical methods for monitoring colorectal or breast cancer. Evaluation of CTC count at any time during the course of disease allows assessment of patient prognosis and is predictive of progression free survival and overall survival. Immunicon makes cell- and molecular-based human diagnostic and life science research products with an initial focus on cancer disease management.