Renewed criticism of FDA s system for vetting devices
WASHINGTON Government investigators say the Food and Drug Administration is putting patients at risk by approving sensitive medical devices such as hip joints and heart defibrillators under the same streamlined system intended for power wheelchairs, stitches, and catheters.

Integra LifeSciences Receives FDA Approvals for Three Spinal Fixation Devices
PLAINSBORO, N.J. -- Integra LifeSciences Holdings Corporation today announced that it has received 510k clearance from the United States Food and Drug Administration for three new spinal intervertebral body fusion devices , continuing to build its momentum in the spine market.

After losing FDA battle, ReGen files for bankruptcy
A Hackensack-based maker of knee implants has filed for Chapter 11 after federal regulators yanked approvals for its flagship project.