3Spine announced today that it received FDA investigational device exemption (IDE) for its Motus spinal implant device. Chattanooga, Tennessee-based 3Spine designed the Motus device for use in the BalancedBack total joint replacement procedure. 3Spine’s BalancedBack procedure is indicated for the biomechanical reconstruction and stabilization of a spinal motion segment following decompression at one lumbar level […]
Spine
FDA clears Medtronic’s ligament augmentation system for spine surgery
Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance and breakthrough device designation for its LigaPASS 2.0. According to a news release, LigaPass is the first and only FDA-cleared device with an indication for ligament augmentation in spine surgery. The company designed the LigaPASS 2.0 ligament augmentation system due to its positive impact on […]
Early study supports experimental hydrogel injection for chronic low back pain
A study demonstrated that an experimental hydrogel formulation was safe and effective in substantially relieving chronic low back pain. Research presented at the Society of Interventional Radiology Annual Scientific Meeting in Boston supported the hydrogel, which was injected into spinal discs in an effort to relieve chronic low back pain caused by degenerative disc disease […]
FDA clears lumbar interbody fusion device from Zavation Medical
Zavation Medical announced today that it received FDA 510(k) clearance for its eZspand lateral expandable lumbar interbody fusion device. Flowood, Mississippi-based Zavation designed the eZspand lateral, part of the Zavation eZspand interbody system, with precision and continual expansion to offer an optimized fit for each patient, allowing for the enhancement of structural stability and improved […]
InVivo Therapeutics completes enrollment in study of Nuero-Spinal Scaffold
InVivo Therapeutics (Nasdaq:NVIV) announced today that it completed enrollment in the Inspire 2.0 study for patients with acute spinal cord injury. Cambridge, Massachusetts–based InVivo’s 20-patient randomized, controlled trial aims to enhance the clinical evidence for the company’s Neuro-Spinal Scaffold. The company designed the Neuro-Spinal Scaffold to encourage functional cells to fill a cavity that will […]
Orthofix announces 5-year positive data for its M6-C artificial cervical disc
Orthofix Medical (Nasdaq:OFIX) today announced positive five-year data from the single-level IDE study of its M6-C artificial cervical disc. Lewisville, Texas–based Orthofix will hold a presentation of the data on June 3 at the International Society for the Advancement of Spine Surgery annual meeting in Nassau, Bahamas. It’s been more than three years since FDA […]
Stryker’s spine guidance software wins FDA clearance
Stryker (NYSE:SYK) announced today that its Q Guidance System for advanced surgery planning received FDA 510(k) clearance. Kalamazoo, Michigan–based Stryker designed the Q Guidance system for use with its spine guidance software for advanced planning and intraoperative guidance that enables open or percutaneous computer-assisted surgery. Q Guidance offers multiple tracking options, sophisticated software algorithms and […]
Si-Bone wins FDA clearance for pelvic fixation, fusion tech
Si-Bone announced today that it received FDA 510(k) clearance for its iFuse Bedrock Granite implant system for spinal procedures. Santa Clara, California-based Si-Bone designed the iFuse “Granite” implant to provide sacroiliac fusion and sacropelvic fixation as a foundational element for segmental spinal fusion. According to a news release, FDA clearance follows earlier breakthrough device designation […]
FDA clears Accelus’ Toro-L interbody fusion system
Accelus announced today that it received FDA 510(k) clearance for its Toro Lateral (Toro-L) interbody fusion system. Palm Beach Gardens, Florida-based Accelus designed its Toro-L biplanar expandable lateral implant for a minimal insertion profile nad maximum bone graft delivery through the inserter. Toro-L includes a 14mm-wide insertion profile, expanding to the implant’s full width of […]
Stryker leaders talk medtech trends at DeviceTalks Boston: ‘If you’re slow, you’re going to lose’
The first day of DeviceTalks Boston closed with a panel of Stryker (NYSE:SYK) executives discussing new tools, technologies and strategies in medtech. Digital VP Tracy Robertson, Digital, Robotics, and Enabling Technologies President Robert Cohen and Surgical Technologies VP of Digital Innovation Siddarth Satish offered their thoughts on industry trends in healthcare and at the Kalamazoo, […]
Globus Medical misses with Q1 results
Globus Medical (NYSE:GMED) posted first-quarter results today that missed the consensus forecast on Wall Street and reaffirmed its outlook for the rest of the year. The Audubon, Pennsylvania–based musculoskeletal solutions developer today reported profits of $38.1 million, or $0.37 per diluted share, on sales of $230.5 million for the three months ended March 31, 2022, […]
