Spinal Fusion Devices
Jan 29, 2026
Seno Medical Secures EU MDR CE Mark for Next-Generation Imagio® Imaging System; Spine Innovation Announces FDA 510(k) Clearance of LOGIC™ Titanium Expandable Interbody System; Laborie Adds JADA® System to Obstetrics Portfolio for Rapid PPH Control; Olympus Introduces SecureFlex™ Single-Use Fine Needle Biopsy Device in the U.S.; Kardium Publishes PULSAR Pivotal Trial Findings in JACC; Myra Vision Begins U.S. ADAPT Glaucoma Study, Treating First Participant
Seno Medical’s Next-Generation Imagio® Imaging System Obtained European Union (EU) Medical Device Regulation (MDR) CE Mark Certification On January 26, 2026, Seno Medical received CE Mark certification for its next-generation Imagio® Imaging System, Model 9100, confirming that the device met the stringent ...
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Jan 22, 2026
Sonomotion Secures FDA Clearance for Break Wave™ Lithotripsy System; Aidoc Earns FDA Clearance for Comprehensive AI Foundation Model in Healthcare; BD and Ypsomed Deepen Partnership to Serve Expanding Biologics Market; Omnia Medical Launches FDA-Approved PsiF DNA™ System to Market; Kardium Publishes PULSAR Pivotal Trial Findings in JACC; NEURO PMR Data Validates Hyperfine’s Diagnostic Precision and Patient-Centered Care
Sonomotion Announced FDA Clearance for its Break Wave™ Lithotripsy Device for Treatment of Kidney Stones On January 21, 2026, SonoMotion, a venture-backed medical device company focused on developing non-invasive solutions for kidney stone treatment, announced that it had received U.S. Food and Drug Admini...
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Jan 08, 2026
Gore Secures FDA Approval for Its First Deep Venous Stent for IVC and Iliofemoral Veins; Stereotaxis Secures FDA Approval for MAGiC Ablation Catheter; Stimlabs® LLC Announces FDA 510(k) Clearance and Launch of Allacor P™ for Wound Care; CorePlus and AIxMED Join Forces to Deliver AI-Powered Bladder Cancer Detection with Complete QC; Interim Clinical Outcomes at Six Months from the SPARTAN Study Evaluating the TransLoc 3D™ System; TYBR Health Reports First U.S. Clinical Use of the B3 GEL™ System
Gore Gained FDA Approval for First Deep Venous Stent Indicated for the IVC and Iliofemoral Veins On January 06, 2026, W. L. Gore & Associates’ medical business (Gore) announced that it had received FDA approval for the GORE® VIABAHN® FORTEGRA Venous Stent, formerly known as the GORE® VIAFORT Vascular S...
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Dec 31, 2025
Spondylolisthesis Medical Devices: Advancing Care Through Innovation
Spondylolisthesis, a formidable spinal condition characterized by the slippage of one vertebra over the one below it, represents a significant global health burden. It is a source of chronic, debilitating low back pain, neurological deficits, and reduced quality of life for millions. Historically, the management of...
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Dec 18, 2025
BD Broadens BD MAX™ System Menu with IVDR-Certified VIASURE Assays; OrthAlign Broadens the Lantern® Hip Platform for Posterior Approach Total Hip Arthroplasty; Bioretec Received FDA Breakthrough Device Designation for the Remeos™ Drillpin; Medivis Achieves First FDA Authorization for AR Navigation in Neurosurgery; Cerapedics Publishes 24-Month ASPIRE Clinical Outcomes in Spine Journal; Acumed’s Acu-Loc NEXT System Debuts in First Wrist Fixation Surgery at Duke University Hospital
BD Expanded BD MAX™ System Menu with New IVDR-Certified VIASURE Assays in Partnership with Certest Biotec On December 15, 2025, BD (Becton, Dickinson and Company), a leading global medical technology company, announced the expansion of its respiratory and sexually transmitted infection (STI) diagnostics po...
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Aug 21, 2025
FDA Grants 510(k) Clearance to Nerveblox AI; Labcorp Introduces the First FDA-Cleared Alzheimer’s Blood Test; Calidar Introduces First-of-its-Kind 4D Mammography System; ONWARD Medical to Initiate Empower BP Pivotal Study Following FDA IDE Approval; Tenon® Medical Launches Catamaran® SE SI Joint Fusion System Nationwide; Rivanna Secures $800,000 Virginia Catalyst Grant Plus Matching Funds to Advance AI-Driven Ultrasound Innovation
Nerveblox, the Ultrasound AI for Regional Anesthesia Received FDA Clearance On August 18, 2025, Nerveblox, an AI-powered software developed by SmartAlpha to assist physicians in performing ultrasound-guided regional anesthesia, received U.S. Food and Drug Administration (FDA) 510(k) clearance. This milesto...
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Aug 07, 2025
SetPoint Medical Earns FDA Nod for First-of-Its-Kind Neuroimmune Modulation Therapy in RA; Body Vision Medical Secures Singapore Pre‑Market Approval for LungVision; BioLab Holdings Initiates Landmark Clinical Trial for Placental Membrane Therapies; Concept Medical Launches MAGICAL-SV IDE Trial; Frenova Enters Strategic Partnership to Push Boundaries in Kidney Precision Medicine; Demetra Acquires OrthoFundamentals and Establishes Global Spine Division
SetPoint Medical Received FDA Approval for Novel Neuroimmune Modulation Therapy for Rheumatoid Arthritis On July 31, 2025, SetPoint Medical, a company focused on developing therapies for individuals with chronic autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) approved its Se...
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Oct 10, 2024
Johnson & Johnson Acquires V-Wave; CalmiGo Launches Anxiety-Management Platform CalmiGo Plus; Vy Spine Secures FDA Clearance for 3D-Printed Lumbar IBF; InspireMD Receives IDE Approval for CGuard Stent Study; GE Healthcare Reveals Phase I MRI Contrast Results; Medinol Completes First Human Implantation of Drug-Eluting Stent
Johnson & Johnson Completed Acquisition of V-Wave On Oct 09, 2024, Johnson & Johnson announced that it successfully completed the acquisition of V-Wave Ltd., a privately-held company dedicated to developing innovative treatments for heart failure patients. V-Wave will now operate under Johnson & John...
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Oct 03, 2024
Establishment Labs Gains FDA Approval for Motiva Implants; Surmodics Receives 510(k) Clearance for Pounce™ XL Thrombectomy System; Synergy Spine Solutions Completes Patient Enrollment in Synergy Disc® 2-Level IDE Clinical Trial; Medtronic Reports Strong Lesion Durability Data for PulseSelect™ Ablation System and Expands AiBLE™ Spine Surgery Ecosystem with Siemens Healthineers Partnership; Globus Medical Launches New Orthopedic Trauma Solutions
Establishment Labs Received U.S. FDA Approval for Motiva Implants On September 26, 2024, Establishment Labs Holdings Inc., a global medical technology company focused on enhancing women’s health and wellness, particularly in breast aesthetics and reconstruction, announced that it received approval from the U.S. ...
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Jul 18, 2024
Inspira™ Approval of INSPIRA™ ART100 System; Oticon Medical’s Sentio™ System Received Regulatory Clearance; SpineGuard Filed its “510K” Dossier in the US; Vectorious Medical Technologies’ V-LAP Left Atrial Pressure Sensor Successful Implantation; Bedal International Raised $11 Million; Mytonomy Inc. Agreement With Vizient, Inc.
Inspira™ Secured Approval From Israeli Authorities for its INSPIRA™ ART100 System On July 11, 2024, Inspira™ Technologies OXY B.H.N. Ltd., a pioneering medical technology company, secured a pivotal milestone with the receipt of the Israeli Ministry of Health's medical devices and accessories ("AMAR") approval fo...
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