Austin, Texas-based Wenzel Spine has launched its newest spine implant, the VariLift-C Stand-Alone Zero-Profile Expandable Cervical Interbody Fusion Device, three months after receiving FDA market clearance.
The FDA has released an update to its plan to monitor medical devices, which includes the use of electronic health records and mobile applications.
Shelton, Conn.-based Spine Wave received FDA 510(k) clearance for its StaXx IB System, an intervertebral body fusion device.
The amount of failed robotic surgeries has tripled from 2008 to 2012 and the FDA intends to investigate and determine the cause, according to a Kaiser Health News report.
Published in Spine
HHS and Federal Communications Commission have selected members for a new workgroup that will promote innovation in health information technology, including mobile medical applications, and identify ways to improve patient safety through health IT.
Atlanta-based MedShape received FDA 510(k) clearance for its Eclipse Soft Tissue Anchor, a shape memory fixation device to attach tendon, ligament and soft tissue to bone.
Last fall Kalamazoo, Mich.-based Stryker voluntarily urged physicians to discontinue use of its ShapeMatch orthopedic product, but recently the FDA upgraded the recall to a Class 1, indicating probability of serious health consequences or death, according to Michigan Live.
The Food and Drug Administration granted 31 orthopedic- and spine-related clearances in March.
The FDA has granted 510(k) clearance to EOS Imaging for its updated sterEOS 3-D imaging software.
InVivo Therapeutics Holdings had its investigational device exemption human trial approved by the FDA for a treatment of spinal cord injuries and neurotrauma conditions.
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