medical device
Mar 05, 2026
Abbott’s New CardioMEMS™ Remote Monitoring Reader Gains FDA Approval; Mobia Medical and Sanford Health Secure FDA Approval for Vivistim Stroke Therapy; Johnson & Johnson Introduces Cereglide™ 42, Cereglide™ 57, and Innerglide™ 7 to Strengthen Catheter Portfolio; Baird Medical Advances Worldwide Registration of AI-Based Surgical Technology; THINK Surgical Achieves First Clinical Use of the TMINI Miniature Robotic System Paired With the Stryker Triathlon Knee System; Monteris Medical Reports Study Linking NeuroBlate® Laser Ablation to Stronger Immunotherapy Response in Recurrent High-Grade Brain Tumors
Abbott’s Next‑Generation Cardiomems™ Remote Heart Failure Monitoring Reader Received FDA Approval to Enhance Patient Experience and Help Detect Disease Progression On 27 February 2026, Abbott announced that the U.S. Food and Drug Administration (FDA) had approved the company’s CardioMEMS™ HERO device, a ne...
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Feb 26, 2026
Galderma Secures Triple Approval for Its New Cutting-Edge Restylane® Syringe Across the European Union, United States, and Canada; 4WEB Medical Secures FDA 510(k) Clearance for New SI Joint Truss System; Medtronic Debuts MiniMed Go Smart Insulin-Delivery System Featuring Simplera Sensor in the EMEA Region; Olympus Expands Labeling to Include Pediatric Use for Two Single-Use Bronchoscopes; Neurent Medical Reports Positive Randomized Controlled Trial Outcomes for the NEUROMARK® System; Envoy Medical Approaches Final Enrollment Phase for Its Fully Implanted Acclaim Cochlear Implant Trial
Galderma Announced Triple Approval of new state-of-the-art Restylane® Syringe in the EU, the U.S., and Canada, Reaffirming the Company’s Position at the Forefront of Injectable Aesthetics On February 25, 2026, Galderma announced that regulatory authorities in the EU, the U.S., and Canada had approved a new...
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Feb 19, 2026
Medtronic Wins FDA Green Light for Stealth AXiS; Retia Medical Secures FDA 510(k) Clearance for Argos Infinity; Danaher Announces Plan to Acquire Masimo Corporation; Dynarex Introduces New Advanced Negative Pressure Therapy Device; Valcare Medical Reports First U.S. Transseptal AMEND™ Implant in Early Feasibility Study; Envoy Medical Reports Enrollment Nearly Complete for Acclaim Cochlear Implant Pivotal Trial
Medtronic Received FDA Clearance for Stealth AXiS™ Surgical System, First Integrated Planning, Navigation and Robotics Platform for Spine Surgery On February 13, 2026, Medtronic, a global leader in healthcare technology, announced U.S. Food and Drug Administration (FDA) clearance of the Stealth AXiS™ surgical sy...
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Feb 12, 2026
Hologic Gains FDA Clearance for Aptima® HPV Assay as Primary Screening Tool; ZOLL Zenix Monitor/Defibrillator Achieves MDR Approval; Labcorp Unveils FDA-Cleared Blood Test for Alzheimer’s Screening; P&F SecureD EU MDR CE Mark Approval for the TricValve® System; Valcare Medical Performs First U.S. Transseptal AMEND™ Implant as Part of Early Feasibility Study; Hyperfine Unveils New Clinical Results Showing Improved Stroke Detection with the Swoop® System
Hologic Received FDA Approval for Aptima® HPV Assay Primary Screening Option, Expanding Cervical Health Portfolio On February 04, 2026, Hologic, Inc. announced that its Aptima® HPV Assay had received FDA approval for clinician-collected HPV primary screening. The test, which was the only FDA-approved mRNA-...
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Feb 05, 2026
GE HealthCare Secures FDA 510(k) Clearance and CE Mark for Allia Moveo, Completing First Global Installation; China NMPA Approves Promega’s MSI Test as a Companion Diagnostic for KEYTRUDA; Oracle Life Sciences AI Data Platform Unifies Data and Agentic Intelligence to Accelerate Breakthroughs and Boost Commercial Outcomes; Quest Diagnostics Launches New Blood Test for Detecting Minimal Residual Myeloma; RevBio Secures FDA Clearance to Begin Pivotal Study of Cranial Bone Glue; Hyperfine Reports Breakthrough Clinical Findings on Swoop® System’s Increased Sensitivity in Stroke Detection
GE HealthCare Announced the U.S. FDA 510(k) Clearance and CE Mark for Allia Moveo and marks first Global Installation, Advancing Precision Care in the Interventional Suite On February 02, 2026, GE HealthCare announced that Allia™ Moveo received U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Mark...
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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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Dec 11, 2025
Bendit Received FDA Clearance for the Bendit17™ Steerable Microcatheter; ProVee System Receives FDA Approval as a New-Era Prostatic Urethral Stent for BPH; a2z Radiology AI Secures $4.5M Seed Funding to Advance Full-Spectrum CT Analysis; MedINT Introduces Advanced Medical AI System Integrating Clinician Oversight; Nitinotes Treats First Patient in Pivotal EASE™ Trial of the EndoZip™ Automated Suturing System for ESG; Airiver Medical Secures FDA IDE Authorization to Launch Pivotal CRS Clinical Trial
Bendit Announced the FDA Clearance for the Bendit17™ Steerable Microcatheter On December 10, 2025, Bendit Technologies announced that the U.S. Food and Drug Administration (FDA) had granted 510(k) clearance for the Bendit17™ Microcatheter, which became the smallest steerable microcatheter available on the market...
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Nov 27, 2025
Bracco Receives FDA Clearance for Additional Clinical Use of Max 3™ Syringeless MR Injector; RapidAI Broadens Clinical AI Portfolio with Five Newly Granted FDA Clearances; Ceribell Secures FDA 510(k) Clearance for Clarity® Algorithm in Neonatal Care; BD Introduces Surgiphor™ Irrigation System Across Europe to Enhance Surgical Patient Protection; Neurophet and The Florey Announce Strengthened Collaboration to Advance Alzheimer’s Diagnostic Solutions; VSI® Performs First-Ever Robotic Minimally Invasive Bertolotti’s Resection; BioWave® Demonstrates Safe and Effective Home-Based and War Injury Pain Relief in Latest Clinical Data
FDA Approved Expanded Indication for Max 3™ Syringeless MR Injector from Bracco On November 25, 2025, Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., announced that the U.S. Food and Drug Administration (FDA) expanded the indication for its Max 3™ Rapid Exchange and Syringeless Injector fo...
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Nov 20, 2025
Zimmer Biomet Secures FDA Clearance for Upgraded ROSA® Knee Robotic System; IceCure’s ProSense® Cryoablation Platform Secures Swissmedic Approval for Use in Breast, Lung, Liver, and Kidney Tumors; Clairity Secures $43M Series B to Launch FDA-Authorized AI Platform for Breast Cancer Risk Prediction; Distalmotion Secures $150M to Boost U.S. Rollout of DEXTER® Robotic Surgery System; Envoy Medical Reaches Six-Month Benchmark with First 10 Patients in Acclaim® Cochlear Implant Trial; Cardiovalve Seeks CE Approval After Positive TARGET Study Results
Zimmer Biomet Received U.S. FDA Clearance for Enhanced Version of ROSA® Knee Robotic Technology On November 14, 2025, Zimmer Biomet Holdings, Inc., a leading global medical technology company, announced that its enhanced ROSA® Knee with OptimiZe™ system received 510(k) clearance from the U.S. Food and Drug...
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Nov 13, 2025
Nitinotes Obtains CE Mark Approval for EndoZip™ System; FDA Grants 510(k) for Meduloc’s Innovative Fixation Solution for Small and Long Bones; Kaneka Launches i-ED COIL™ in Europe; Motive Health Unveils New At-Home Therapy for Lower Back Relief; Gore Reports Strong 12-Month Results for VIABAHN® FORTEGRA Venous Stent in Iliocaval Disease; Vexev Marks Completion of Enrollment in AV Fistula Mapping Clinical Study
Nitinotes Received CE Mark Approval of EndoZip™, the First Fully Automated Suturing System for Endoscopic Sleeve Gastroplasty On November 06, 2025, Nitinotes Ltd., a medical device company focused on transforming obesity treatment, announced that it had received CE Mark approval for its EndoZip™ System, th...
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