JUPITER, FL, December 10, 2024 — Atlas Spine, Inc., a spinal implant company based in Jupiter Florida, announced today they have received 510(k) clearance from the FDA for the HiJAK Expandable Lateral Lumbar Interbody System. Atlas is answering the evolving market needs of lateral fusion procedures with the introduction of HiJAK … [Read more...] about Atlas Spine Announces FDA Clearance of its HiJAK Expandable Lateral Lumbar Interbody System
NEWS
Theradaptive Obtains FDA IDE Approval to Study OsteoAdapt™ SP in Additional Spinal Fusion Indications
FREDERICK, Md., Dec. 10, 2024 /PRNewswire/ -- Theradaptive, a privately held, clinical stage biologics company developing protein therapeutics for spine, orthopedics, soft tissue repair, and targeted immuno-oncology, announced today that the US Food and Drug Administration (FDA) has approved an expansion to its Phase I/II clinical program, broadening it to include … [Read more...] about Theradaptive Obtains FDA IDE Approval to Study OsteoAdapt™ SP in Additional Spinal Fusion Indications
PainTEQ Secures Groundbreaking Patent for LINQ® Technology Advancing Precision and Efficiency in SI Joint Fusion
TAMPA, Fla., Dec. 9, 2024 /PRNewswire/ -- PainTEQ, a leader in minimally invasive sacroiliac (SI) joint dysfunction treatment, has been awarded a new patent (US Patent No. 12,121,458), marking another significant milestone in the advancement of its innovative LinQ® SI Joint Stabilization System. This latest patent expands the breadth of PainTEQ's single-use instrumentation … [Read more...] about PainTEQ Secures Groundbreaking Patent for LINQ® Technology Advancing Precision and Efficiency in SI Joint Fusion
The Importance of Sales Representatives in the Operating Room: Supporting Spinal Surgeries
In the spine business, certain questions frequently arise: Is the presence of a sales representative in the operating room necessary? Does their involvement increase the company’s risk exposure? While these concerns are valid, the evidence points to a clear conclusion: sales representatives play a critical role in ensuring the success of surgical procedures. Their presence … [Read more...] about The Importance of Sales Representatives in the Operating Room: Supporting Spinal Surgeries
Study at HSS Compares Robotic-Assisted Navigation and Augmented Reality in Spine Surgery
A recent study conducted at the Hospital for Special Surgery (HSS) has shown that both robotic-assisted navigation (RAN) and augmented reality (AR) technologies achieve remarkable precision and safety in placing pedicle screws during spinal surgeries. The findings, published online ahead of print in the journal Spine, represent the first head-to-head comparison of these two … [Read more...] about Study at HSS Compares Robotic-Assisted Navigation and Augmented Reality in Spine Surgery
Curiteva Surpasses 2,000 Procedures With Inspire(R)C Cervical Trabecular PEEK(TM) With HAFUSE(R) Technology
December 4, 2024 (Newswire.com) - Curiteva, Inc., a privately held manufacturing and technology company, today announced it has implanted over 2,000 patients with the Inspire®C Cervical Interbody Fusion Device. This success translates to more than 3,700 implants placed, demonstrating the system's rapid adoption and effectiveness since its commercial launch in July … [Read more...] about Curiteva Surpasses 2,000 Procedures With Inspire(R)C Cervical Trabecular PEEK(TM) With HAFUSE(R) Technology
Tyber Medical Achieves Class III MDR CE Mark Certification from BSI for PEEK Titanium Plasma-Coated Cervical Cages
BETHLEHEM, Pa., Dec. 5, 2024 /PRNewswire/ -- Tyber Medical LLC, a leading provider of private-label orthopedic and spinal implants, proudly announces that it has received Medical Device Regulation (MDR) CE Mark certification from BSI for its PEEK Titanium Plasma-coated cervical cages. This certification for Tyber Medical's innovative technology is a pivotal step … [Read more...] about Tyber Medical Achieves Class III MDR CE Mark Certification from BSI for PEEK Titanium Plasma-Coated Cervical Cages
Introducing the FJ-f Interfacet Implant: Advancing Spinal Stabilization with Innovative Solutions
This year’s EUROSPINE 2024 symposium in Vienna is now behind us. It was a significant event for specialists in spine surgery. The gathering provided an excellent opportunity for showcasing innovations and exchanging experiences among surgeons from various countries. One of the program highlights was the presentation of the FJ-f intra-articular implant (Facet Joint … [Read more...] about Introducing the FJ-f Interfacet Implant: Advancing Spinal Stabilization with Innovative Solutions
NovApproach Spine Enters International Market
First Surgeries Using OneLIF™ Interbody Fusion Cage in Panama Alachua, Fla. Alachua, Fla. (December 4, 2024) – NovApproach Spine, developer of the patented OneLIF™ interbody spinal fusion system which supports a multitude of surgical approaches, announced today its entry into the Panamanian market with two surgeries performed last week. Dr. Gamaliel Gonzalez Atencio at the … [Read more...] about NovApproach Spine Enters International Market
Carlsmed Announces FDA Clearance for aprevo® Cervical Breakthrough Fusion Device
CARLSBAD, Calif.--(BUSINESS WIRE)--Carlsmed, Inc. (“Carlsmed” or the “Company”) a MedTech company pioneering AI-enabled personalized spine surgery, today announced FDA 510(k) clearance for the aprevo® Cervical ACDF Interbody System. This milestone underscores Carlsmed’s commitment to advancing patient-specific spine surgery solutions that enhance outcomes and surgical … [Read more...] about Carlsmed Announces FDA Clearance for aprevo® Cervical Breakthrough Fusion Device
A New Era in Back Pain Treatment: Discseel® Procedure is Proven Effective and Able to Replace Most Spine Surgeries in a Recent Groundbreaking Study
DALLAS, Dec. 4, 2024 /PRNewswire/ -- This study is the World's largest Spine Regenerative Medicine study. 3-year results of the Discseel® Procedure were published in Pain Physician Journal and demonstrate high safety and efficacy in treating chronic low back pain and sciatica (radiculopathy.) The study's Lead Investigator, Kevin Pauza MD, Founding Partner of Texas … [Read more...] about A New Era in Back Pain Treatment: Discseel® Procedure is Proven Effective and Able to Replace Most Spine Surgeries in a Recent Groundbreaking Study
Neo Medical’s Spine Care Platform Fully Approved Under EU Medical Device Regulation Directive
LAUSANNE, Switzerland--(BUSINESS WIRE)--Neo Medical SA (Neo), a Swiss technology company specializing in spine surgery, today announced the approval of its entire product portfolio under the European Union’s (EU) Medical Device Regulation (MDR) EU 2017/745, confirming compliance with the world’s highest quality control standards for medical devices. Certification allows Neo … [Read more...] about Neo Medical’s Spine Care Platform Fully Approved Under EU Medical Device Regulation Directive
Viz.ai Collaborates with Microsoft to Advance AI-powered Clinical Workflows and Better Patient Care
SAN FRANCISCO--(BUSINESS WIRE)--Viz.ai, a leader in AI-powered disease detection and intelligent care coordination, today announced a collaboration with Microsoft to deliver its AI models and care coordination solution with Precision Imaging Network, part of Microsoft Cloud for Healthcare. Together, Precision Imaging Network and Viz.ai deliver a comprehensive solution with more … [Read more...] about Viz.ai Collaborates with Microsoft to Advance AI-powered Clinical Workflows and Better Patient Care
VUZE Medical Showcases concurrent Multi-Tool 3D Guidance in Spine Surgery, with no Navigational Hardware and Using Standard Pre-Op CT
RA’ANANA, Israel – Nov. 25, 2024 – VUZE Medical, a privately-held company aiming to transform intra-operative guidance in spinal interventions currently aided only by 2D X-ray, has recently demonstrated concurrent software-based 3D guidance of dual-sided vertebral insertions. The new Tandem mode, which is not yet approved for clinical use, was recently introduced in … [Read more...] about VUZE Medical Showcases concurrent Multi-Tool 3D Guidance in Spine Surgery, with no Navigational Hardware and Using Standard Pre-Op CT
Paradigm Spine GmbH Celebrates 20 Years of Innovation in Spinal Care
Hamburg, Germany – This year marks a major milestone for Paradigm Spine GmbH, an Xtant Medical company, as we celebrate 20 years of innovation and commitment to advancing spinal care. Over the past two decades, Paradigm Spine has been at the forefront of developing cutting-edge spinal implants, earning the trust of healthcare professionals around the world. We want to take … [Read more...] about Paradigm Spine GmbH Celebrates 20 Years of Innovation in Spinal Care
Globus Medical Launches ExcelsiusHub™ Navigation System
AUDUBON, Pa., Nov. 22, 2024 (GLOBE NEWSWIRE) -- Globus Medical, Inc. (NYSE: GMED), a leading musculoskeletal solutions company, today announced the commercial launch of the ExcelsiusHub™ navigation system. ExcelsiusHub™ joins the expansive ecosystem of Excelsius™ technologies and is designed to elevate the standard for freehand navigation. Freehand navigation provides … [Read more...] about Globus Medical Launches ExcelsiusHub™ Navigation System
The Navy SEALs of Medical Devices: The Exceptional Work of Spine Reps!
In the vast and varied world of medical devices, each market presents its unique challenges and demands. From surgical instruments to prosthetics, every segment requires skilled professionals to ensure the success of its products. Yet, among all these areas, spine implant sales representatives stand out as some of the most complete, highly trained, and committed professionals … [Read more...] about The Navy SEALs of Medical Devices: The Exceptional Work of Spine Reps!
Novadip’s NVDX3 reaches key milestones leading to IND approval from FDA to start phase 2b/3 study in cervical spine fusion
Mont Saint-Guibert, Belgium, November 20, 2024 – Novadip Biosciences, a clinical stage biotechnology company specializing in regenerative medicine, today announces approval from the US Food and Drug Administration (FDA) for its allogenic bone grafting material NVDX3 to enter an investigational new drug study (IND). NVDX3 is an allogenic bone grafting material forming a new … [Read more...] about Novadip’s NVDX3 reaches key milestones leading to IND approval from FDA to start phase 2b/3 study in cervical spine fusion
Augmedics Announces FDA Clearance, Completion of First Surgery for New CT-Fluoro Registration
CHICAGO--(BUSINESS WIRE)--Augmedics, a pioneer in augmented reality (AR) surgical navigation, today announced FDA 510(k) clearance of a new registration method for its xvision Spine System®. The xvision CT-to-fluoroscopy (CT-Fluoro) registration method allows surgeons to navigate off a preoperative CT scan and fluoroscopic images from a standard 2D C-arm, eliminating the need … [Read more...] about Augmedics Announces FDA Clearance, Completion of First Surgery for New CT-Fluoro Registration