• Amedica (Salt Lake City) said the FDA has granted 510(k) marketing clearance to Amedica’s Valeo cervical plate system. The system is intended for anterior screw fixation at the C2 through C7 vertebral bodies of the cervical spine. The implant and related instruments are designed to facilitate placement of the cervical plate and ensure proper angling and insertion of the screws into the vertebrae in a single step, to achieve a consistent supplemental fixation outcome. Amedica is an orthopedic implants company focused on silicon nitride ceramic technologies.

• IRIS International (Chatsworth, California) said that its sample processing division has initiated shipments of its new, high speed, horizontal centrifuge, the StatSpin Express 4. The StatSpin uses a horizontal rotor for separating gel tubes in just minutes and replaces larger and slower, batch centrifuges by reducing sample preparation time and streamlining laboratory workflow. This new product platform enables Iris Sample Processing entry into the high volume chemistry test market and further application expansion in blood and body fluids. IRIS International makes automated IVD urinalysis systems.

• JHD Group (Dallas) said that it is rolling out a new turnkey electronic medical record (EMR) and practice management system (PMS) service to enhance its ability to meet the growing demands of its clients. It will offer healthcare organizations such as hospitals, IPA’s, and physician groups an option for implementing and operating a physician clinical integration solution (EMR – PMS) through an ASP model which greatly reduces risk, expedites the implementation process, is competitively priced, and is sustainable over the long-term. JHD Group is a healthcare consulting group and management firm specializing in physician organizations.

• VertiFlex (San Clemente, California) reported commercial introduction of the Silverbolt MIS screw system to the U.S. market. The system will serve as a platform for percutaneous and mini-open fusion procedures. Designed as a percutaneous geometric approach, the Silverbolt system was engineered to meet the concerns of surgeons. A pre-lordosed ball-end rod is delivered into the screw head in a single step, while a draw bridge mechanism pushes the rod into the adjacent screw. No additional incisions are needed and the company said the design ensures alignment even in the more difficult L5-S1 cases, while assuring accuracy of the rod delivery during a minimally invasive procedure. Silverbolt also allows for reduction of up to Grade 2 spondylolithesis percutaneously. VertiFlex makes minimally invasive and motion preservation technologies for disorders of the spine.

• VertiFlex (San Clemente, California) also reported the release of the Superion interspinous spacer to countries outside the U.S. The Superion implant is placed percutaneously between the spinous processes without the need to cut paraspinal muscles. It is primarily designed to offer relief from neurogenic intermittent claudication and leg pain commonly associated with spinal stenosis. The Superion surgical technique does not require damage or harm to any of the anatomical elements. A small incision is made posteriorly to the midline and the implant is delivered through a small cannula. The entire surgery is performed under local anesthesia and the average surgery time has been 25 minutes or less. VertiFlex makes minimally invasive and motion preservation technologies for disorders of the spine.