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Spine

3Spine wins FDA IDE for spine implant

June 22, 2022 By Sean Whooley

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 […]

Filed Under: Clinical Trials, Food & Drug Administration (FDA), Implants, Orthopedics, Regulatory/Compliance, Spine Tagged With: 3Spine

FDA clears Medtronic’s ligament augmentation system for spine surgery

June 21, 2022 By Sean Whooley

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 […]

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Health Technology, News Well, Orthopedics, Regulatory/Compliance, Software / IT, Spine Tagged With: Medtronic

Early study supports experimental hydrogel injection for chronic low back pain

June 13, 2022 By Sean Whooley

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Orthopedics, Pain Management, Spine Tagged With: hydrogel, hydrogels, ReGelTec

FDA clears lumbar interbody fusion device from Zavation Medical

June 10, 2022 By Sean Whooley

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 […]

Filed Under: 510(k), Food & Drug Administration (FDA), Implants, Orthopedics, Regulatory/Compliance, Spine Tagged With: zavationmedical

InVivo Therapeutics completes enrollment in study of Nuero-Spinal Scaffold

June 2, 2022 By Sean Whooley

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 […]

Filed Under: Clinical Trials, Implants, Neurological, Spine Tagged With: InVivo Therapeutics

Orthofix announces 5-year positive data for its M6-C artificial cervical disc

May 31, 2022 By Chris Newmarker

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 […]

Filed Under: Clinical Trials, Orthopedics, Spine Tagged With: Orthofix

Stryker’s spine guidance software wins FDA clearance

May 31, 2022 By Sean Whooley

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 […]

Filed Under: 510(k), Business/Financial News, Food & Drug Administration (FDA), Health Technology, News Well, Orthopedics, Regulatory/Compliance, Software / IT, Spine, Surgical Tagged With: FDA, Stryker

Si-Bone wins FDA clearance for pelvic fixation, fusion tech

May 31, 2022 By Sean Whooley

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 […]

Filed Under: 510(k), Food & Drug Administration (FDA), Implants, News Well, Orthopedics, Regulatory/Compliance, Spine Tagged With: FDA, Si-Bone

FDA clears Accelus’ Toro-L interbody fusion system

May 19, 2022 By Sean Whooley

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 […]

Filed Under: 510(k), Food & Drug Administration (FDA), Implants, Orthopedics, Regulatory/Compliance, Spine

Stryker leaders talk medtech trends at DeviceTalks Boston: ‘If you’re slow, you’re going to lose’

May 11, 2022 By Jim Hammerand

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, […]

Filed Under: Big Data, Blog, Distribution, Electronic Medical Records (EMR), Featured, Health Information Technology, Health Technology, Hospital Care, Imaging, Metal-on-Metal, News Well, Orthopedics, Regulatory/Compliance, Software / IT, Spine Tagged With: AI, artificial intelli, Cloud, cloud computing, Cybersecurity, DeviceTalks Boston, Stryker

Globus Medical misses with Q1 results

May 10, 2022 By Jim Hammerand

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, […]

Filed Under: Blog, Business/Financial News, MassDevice Earnings Roundup, News Well, Spine, Wall Street Beat Tagged With: Globus Medical

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