The Orthopaedic and Rehabilitation Advisory Panel recommended FDA require a randomized, sham-control study design with a well-defined patient population to prove safety and effectiveness for the devices. The agency is currently considering whether to retain the preamendments device category in class III or downclassify to class II.

Recent executive-level hires and director appointments at venture capital firms and biopharma and medtech start-ups.

Although big companies grabbed the headlines with problems, 2006 proved to be a strong year for the medical device industry and growth prospects look strong. Our selection of the device industry highlights of 2006 includes: Boston Scientific-Guidant deal: the winner may be Abbott; Device IPO market remains strong; Drug-eluting stent safety debate; Conflicts of interest: (physician relationships with companies); The bid for Biomet; VC Pendulum shifts towards medical devices; Kyphon bids for St. Francis; and Diagnostic imaging and in vitro diagnostics converge.