Spineology announced that 24-month outcomes from its Scout clinical trial for interbody fusion revealed substantial improvements in scores for low back pain and functional limitations. The Scout trial was conducted under an FDA-approved investigational device exemption protocol to evaluate safety and effectiveness outcomes in instrumented lumbar interbody fusion procedures for treating degenerative disc disease. Spineology […]
FDA clears DiFusion’s spinal implant with new biomaterial
DiFusion said today that it won FDA 510(k) clearance for its Xiphos-ZF spinal interbody device, the first spinal implant developed from the biomaterial Zfuze. Zfuze is a new biomaterial that is said to elicit pro-reparative M2 macrophage response and significant reductions in Interleukin 1-Beta and Interleukin 6. Both IL1-Beta and IL6 are cytokine markers for prolonged […]
FDA clears Stryker’s Sahara expandable interbody implant
Stryker (NYSE:SYK) said yesterday that it won FDA 510(k) clearance for its Sahara lateral 3D expandable interbody implant system. Sahara Lateral is the first ever 3D-printed lateral expandable fusion device, according to a news release. It is designed to allow surgeons up to 30 degrees of sagittal spinal correction in skeletally mature patients. The implant is […]
NuVasive gains on beat-n-raise Q3 numbers
NuVasive (NSDQ:NUVA) shares are up today after the spine implant maker reported beat-and-raise third-quarter results. San Diego-based NuVasive posted profits of $11.0 million, or 21¢ per share, on sales of $290.8 million for the three months ended Sept. 30, for a bottom-line slide of -30.9% on revenue growth of 20.2%. Adjusted to exclude one-time items, earnings […]
Orthofix earnings plummet as sales miss projections
Orthofix (NSDQ:OFIX) shares fell in pre-market trading today on third-quarter results that came up short of the consensus forecast, a cut to its bottom-line outlook and the naming of a new chief executive. The Lewisville, Texas-based company posted losses of -$40.5 million, or -$2.14 per share, on sales of $113.5 million for the three months ended […]
Life Spine, execs agree to $6m settlement in kickbacks case
Life Spine and its two top executives agreed to collectively pay nearly $6 million to settle charges that they ran an illegal kickbacks scheme to promote the use of its orthopedic implants. The case dates back to February 2018, when a quartet of anonymous whistleblowers filed a False Claims Act suit alleging that the Huntley, […]
European spinal cord stim outfits GTX Medical and NeuroRecovery Technologies to merge
GTX Medical and NeuroRecovery Technologies today announced their merger into a global company for the development of neuromodulation therapies for spinal cord injuries. The two merging companies plan to develop the targeted epidural spine stimulation system, an implantable spinal cord stimulation platform designed to restore locomotion in patients with spinal cord injury with real-time motion […]
Synaptive Medical, Stryker ink co-marketing deal
Synaptive Medical said today that it inked a co-marketing deal with Stryker (NYSE:SYK) for its Modus V digital microscope as it begins a strategic commercial expansion into the spinal surgery market. The Modus V is a robotically controlled digital microscope used as part of Synaptive’s BrightMatter surgical suite designed for less invasive, patient-specific approaches in complex […]
Xoran raises $8m for portable CT scanner
Xoran Technologies said yesterday that it landed a total of $8 million from a matching grant program with the National Institutes of Health for its xCAT IQ mobile CT imaging system. Ann Arbor, Mich.-based Xoran’s xCAT IQ is a compact, mobile CT scanner designed for high-resolution cranial imaging in the operating room and intensive care […]
Medtronic appeals $24m patent loss to Supremes
Medtronic (NYSE:MDT) has asked the U.S. Supreme Court to overturn its nearly $24 million loss in a patent infringement lawsuit brought by a physician inventor. In February 2014, Dr. Mark Barry alleged that Fridley, Minn.-based Medtronic infringed on three patents covering a “system and method for aligning vertebrae in the amelioration of aberrant spinal column […]
Medtronic announces Infuse spine trial
Medtronic (NYSE:MDT) said today that it won FDA approval for a clinical trial of its Infuse bone graft in transforaminal lumbar interbody fusion spine procedures. The Minneapolis-based company started recruiting for the prospective, randomized pivotal trial, which is slated to enroll up to 1,000 patients. The TLIF trial would be the second clinical trial for Infuse, […]
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