Spine
FDA panel green lights VertiFlex spinal stenosis device
A FDA advisory panel has recommended the agency approve VertiFlex Inc.’s Superion interspinous spacer system for the treatment of spinal stenosis.
According to VertiFlex, the panel based their vote largely on results from the company's 470-patient clinical trial.
FDA expands indication for Medtronic’s Vertex spine implant
Medtronic (NYSE:MDT) said today that it won an expanded indication from the FDA for its Vertex spinal fixation system, covering lateral mass and pedicle screw use in the posterior cervical spine.
Medtronic said the expanded indication makes it 1 of the 1st systems cleared in the U.S. for use of screws at vertebrae C1 to C7.
DePuy Synthes Spine wins expanded approval for Synapse spinal device
K2M registers for $40m follow-on
InVivo cleared to advance spinal injury study
FDA OKs expedited enrollment for InVivo study
FDA postpones panel meeting for VertiFlex’s Superion spine device
The FDA postponed a meeting of 1 of its advisory panels that’s slated to review the pre-market approval application for the Superion spine implant made by VertiFlex.
Zyga Technology raises $2m
Zyga Technology said it raised $2 million in an equity-and-options round it hopes will eventually bring in $5 million.
Four unnamed investors participated in the round, according to a regulatory filing.