FDA APPROVED

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

SEATTLE, April 8, 2025 /PRNewswire/ -- Proprio, the global leader in AI-powered surgical technology, today announced that its AI guidance platform for surgery, Paradigm, has received its second major 510(k) clearance from the U.S. Food and Drug Administration (FDA) to include intraoperative measurements. This is the first-ever technology that enables 3D, dynamic … [Read more...] about Proprio Receives FDA Clearance For the World’s First AI Surgical Guidance Platform

NEW YORK, April 2, 2025 /PRNewswire/ -- Medivis Inc., a pioneer in surgical intelligence, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking Spine Navigation platform. This milestone marks a significant advancement in surgical technology, utilizing AR and AI to empower surgeons with holographic … [Read more...] about Medivis Receives FDA 510(k) Clearance for Spine Navigation and Announces Commercial Launch in the United States

CARLSBAD, Calif., March 25, 2025 (GLOBE NEWSWIRE) -- Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a leader in innovative spine and interventional pain management solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Company’s newest product, the AERO™ Facet Fusion System. The … [Read more...] about Aurora Spine Announces FDA 510(k) Clearance for the AERO™ Facet Fusion System

NONNWEILER, SAARLAND, GERMANY, March 19, 2025 /EINPresswire.com/ -- NGMedical GmbH, a medical device manufacturer exclusively focused on creating innovative technologies for spinal application, announces approval of MOVE®-C artificial disc prosthesis by TGA for sales in Australia. We are thrilled to announce TGA approval for our groundbreaking cervical disc arthroplasty … [Read more...] about NGMedical Announces Australian TGA approval for MOVE®-C cervical artificial disc

East Hartford, CT – [March 2025] – icotec is proud to announce that it has received FDA 510(k) clearance for the use of an Axial and Parallel Connectors on its VADER® Pedicle Systems. This clearance marks a significant milestone for icotec, as it continues to innovate and provide advanced solutions for spinal stabilization. The extended  VADER® Pedicle System maintains … [Read more...] about icotec’s VADER® Pedicle Systems: Axial and Parallel Connectors Receive 510(k) Clearance in the USA

Dallas, Texas and Franklin, Tennessee, March 13, 2025 — Spineart, a fast-growing company in spine surgery innovation, and eCential Robotics, an expert company in surgical robotics, proudly announce the 510(k) clearance from the U.S. Food and Drug Administration (FDA) of the Spineart PERLA® TL application (PERLA® App) for use with the new eCential Robotics Op.nTM robotic … [Read more...] about Spineart and eCential Robotics announce FDA clearance of PERLA® App for use with Op.nTM robotic navigation platform

Alzenau, 26/02/2025 – SIGNUS Medizintechnik GmbH is proud to announce the successful FDA approval of the CYLOX® ST cage and plate system. This FDA clearance marks a significant milestone in the expansion of our product range in the US market as well as in advancing spinal care, ensuring improved patient outcomes and procedural efficiency. SIGNUS is dedicated to the … [Read more...] about SIGNUS Receives FDA Approval for CYLOX® ST cage and plate system

HUNTLEY, Ill.--(BUSINESS WIRE)--Life Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market GRUVE + Cervical Plating System. GRUVE + (plus) Cervical Plating System establishes a … [Read more...] about Life Spine Announces FDA 510(k) Clearance for the GRUVE® + Cervical Plating System

HUNTLEY, Ill.--(BUSINESS WIRE)--Life Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the ProLift Pivot Expandable Spacer System. The ProLift Pivot System represents the … [Read more...] about Life Spine Announces FDA 510(k) Clearance for the ProLift® Pivot Expandable Spacer System

EAST HARTFORD, Conn., Jan. 14, 2025 /PRNewswire/ -- icotec is proud to announce that it has received FDA clearance for the use of BlackArmor® implants in the treatment of de novo spinal infections. icotec is honored to be the first and only company in the United States with FDA 510(k) clearance for stabilizing the spine in de novo spinal infections, … [Read more...] about icotec Announces FDA clearance for Spinal Infection Indication with BlackArmor® Implants