FDA APPROVED

August 22, 2025 – Altstätten, Switzerland – icotec ag, the leading medical device manufacturer of Carbon/PEEK spinal implants, announces the CE approval under the European Medical Device Regulation (MDR) to market the VADER® Pedicle System inclusive of Ø 4.5 mm pedicle screws and long Carbon/PEEK rods made from BlackArmor® and its use with Medtronic StealthStation™ navigation … [Read more...] about VADER® Pedicle System – CE Approval under MDR for Line Extension & Navigated Instruments

Plano, TX, August 18, 2025 --(PR.com)-- Eminent Spine announced today that its trailing twelve-month total income for the period ending June 2025 has risen by nearly 70%, underscoring the company’s strong momentum and expanding presence in the spine market. This milestone comes as the company celebrates the Alpha Launch of the world’s only FDA-approved 3D Printed Titanium … [Read more...] about Eminent Spine Reports 70% Growth in Trailing 12-Month Income and Celebrates Alpha Launch of FDA-Approved 3D Printed Titanium Pedicle Screw

TORONTO, Aug. 15, 2025 /PRNewswire/ - SpinaFX Medical Inc., ("SpinaFX") a leading innovator in image-guided interventional spine care, is proud to announce that its flagship device, Triojection®, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This milestone acknowledges Triojection's potential to offer a highly … [Read more...] about Triojection® from SpinaFX Granted Breakthrough Device Designation by U.S. FDA for Minimally Invasive Lumbar Disc Treatment

Spinal Simplicity's IntraLink technology, an injectable treatment for symptomatic disc degeneration, has received FDA Breakthrough Device Designation—fast-tracking review and potentially enabling earlier intervention for patients. Early clinical trials showed significant, sustained pain and disability improvements in over 80% of treated patients. OVERLAND PARK, Kan., Aug. … [Read more...] about Spinal Simplicity Secures FDA Breakthrough Device Designation for IntraLink™

INLET BEACH, FL, UNITED STATES, July 22, 2025 /EINPresswire.com/ -- Spectrum Spine Inc is pleased to announce U.S. FDA clearance of its lumbar family of cage implants. These devices incorporate BioBraille surface treatment on the bone contact areas and the interior of the graft window. The family includes PLIF/TLIF, Oblique TLIF, DLIF and ALIF procedural solutions. An ultra … [Read more...] about Spectrum Spine Inc Clears US FDA with Family of Lumbar Interbody Cages with BioBraille

AUSTIN, Texas--(BUSINESS WIRE)--Wenzel Spine, Inc., a medical technology company focused on minimally invasive surgical and analytic solutions for spinal disorders, today announced it has received FDA clearance for its revolutionary expandable sacroiliac (SI) fusion implant, panaSIa. This milestone marks the first ever FDA clearance of an expandable SI fusion implant, … [Read more...] about Wenzel Spine Receives FDA Clearance for First Expandable Sacroiliac (SI) Fusion Implant, panaSIa™

OREM, Utah, July 10, 2025 /PRNewswire/ -- Dymicron®, a privately held medical device company pioneering advanced spinal technologies, today announced that the United States (U.S.) Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to begin a pivotal clinical study of the Triadyme®–C cervical artificial disc. This … [Read more...] about Dymicron Granted IDE Approval for Triadyme-C Artificial Disc

Johnson & Johnson has announced that its TriALTIS™ Spine System has received CE mark approval, marking a significant step forward in its commitment to advancing spinal care through innovation, reliability, and technology. The TriALTIS™ Spine System is a next-generation posterior thoracolumbar pedicle screw system that provides a comprehensive product offering, … [Read more...] about TriALTIS™ Core System Receives CE Mark Approval

HUNTSVILLE, Ala., June 24, 2025 (Newswire.com) - Curiteva is proud to announce FDA 510(k) clearance for the Inspire Trabecular PEEK Standalone ALIF system, the first-ever 3D printed PEEK standalone implant. This is the company's latest FDA cleared 3D Printed PEEK implant with HAFUSE technology. This milestone represents a significant leap forward in advanced medical … [Read more...] about Curiteva(R) Secures FDA 510(k) Clearance for Inspire(R) Trabecular PEEK Standalone ALIF System

We are pleased to announce that Global Biomedica s.r.o., a company specializing in advanced spinal solutions, has successfully obtained CE certification in accordance with the European Medical Device Regulation (EU MDR 2017/745) for its flagship product line - BMD Titanium Implant. The BMD Titanium Implant family has undergone rigorous assessment to ensure full compliance … [Read more...] about BMD Titanium Implant Products by Global Biomedica Receive CE Certification under EU MDR

Mountain View, CA – June 16, 2025 – Expanding Innovations™ (EI), a rapidly growing spine company specializing in NON-SCREW-based Expandable Technology, today announced U.S. FDA 510(k) clearance for its N-GAGE™ Lumbar Plate System—the company’s first spinal fixation platform as it continues to broaden its procedure-based solutions. The modular, low-profile … [Read more...] about Expanding Innovations Receives FDA Clearance for N-GAGE™ Lumbar Plate System

Fleurieux-sur-l’Arbresle - France - June 5, 2025 at 6 p.m. Safe Group, a leading player in the field of medical devices for spine surgery, is pleased to announce that Frida, the innovative cervical plate developed by SpineUp, has received 510(k) clearance from the Food and Drug Administration (FDA). This clearance marks a crucial step in SpineUp's expansion into … [Read more...] about Safe Group announces FDA 510(k) clearance for SpineUp’s Frida solution

PETACH TIKVA, Israel, June 05, 2025 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD ("Nanox" or the "Company", Nasdaq: NNOX), an innovative medical imaging technology company, today announced that its deep-learning medical imaging analytics subsidiary, Nanox AI Ltd, has received EU MDR CE (Conformité Européenne) mark certification for HealthOST, an SaMD (Software as a medical device) … [Read more...] about Nanox Receives MDR CE Mark for HealthOST, an Advanced AI-Powered Software for Spine Assessment

JACKSON, Miss., May 22, 2025 /PRNewswire/ -- MSKai, an advanced image identification and post-processing software platform for spine imaging, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), authorizing its use by physicians and radiologists for lumbar spine MRI analysis. The FDA determined that MSKai is substantially equivalent to … [Read more...] about MSKai Spine Imaging Software Receives FDA 510(k) Clearance for Clinical Use

Plano, TX, May 07, 2025 --(PR.com)-- Eminent Spine, a leader in spinal implant innovation, proudly announces that its revolutionary 3D Printed Titanium Pedicle Screw System has received FDA 510(k) clearance as of April 28, 2025 — making it the first and only FDA 510(k)-cleared 3D printed pedicle screw system in the world. “This historic achievement represents a monumental … [Read more...] about Eminent Spine’s 3D Printed Titanium Pedicle Screw System Receives Groundbreaking FDA 510(k) Clearance. The Future of Fusion Has Arrived.

BERN, Switzerland, April 24, 2025 (Newswire.com) - LEM Surgical, a developer of advanced robotic technologies for hard tissue surgery, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Dynamis Robotic Surgical System, marking a significant milestone in the evolution of robotic-assisted hard tissue surgery. The … [Read more...] about LEM Surgical Announces FDA Clearance of Dynamis Robotic Surgical System