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FDA clears Baxano’s iO-Tome spinal device

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Silicon Valley-based spinal surgery company Baxano won FDA clearance for its iO-Tome device, which could help surgeons remove the facet joint rapidly and precisely during spinal fusion procedures.

Baxano’s iO-Tome system works with the company’s flagship device, the iO-Flex suite of flexible surgical instruments, for patients that require spinal fusion.

The new instrument could help make surgery "simple, fast, safe and repeatable in all hands and could reduce the learning curve significantly,” Dr. Robert Isaacs, a North Carolina neurosurgeon, said on behalf of the company.

“The iO-Tome represents a tremendous step forward into the fusion market for Baxano,” president & CEO Tony Recupero said in prepared remarks. “The development of an efficient instrument that has the potential to save substantial OR time, provide reproducible results, and is compatible with emerging spinal fusion technologies further highlights the capabilities of our core ‘-inside-out-‘ technology platform.”

Baxano recently fended off rumors of harsh layoffs, telling MassDevice.com in July that online speculation about lackluster sales were an "exaggeration," that the company has "plenty of money."

A report on "The Spine Blogger," which bills itself as "the people’s blog site where news, ideas, job opportunities and what’s been heard on the street can be discussed in a professional manner," reported over the summer that Baxano had let go of 20% of its workforce due to "inadequate funding and sales" and that the company was "potentially in the initially [sic] stages of a shutdown," as verified by the site’s "sources on the Street."

"That’s not true at all," Baxano marketing vice president Amie Borgstrom told MassDevice.com at the time. "I’m not sure where that came from."

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