medical device
Jan 30, 2025
Norlase’s LYNX Receives FDA and CE Approval for Clinical Use; FDA Approves Imperative Care’s Zoom System; Lunit AI Enhances Predictive Accuracy for HER2-Targeted Therapy in Metastatic Colorectal Cancer; ImmunoMet Reports New Insights from Phase 1b Study of Lixumistat in Pancreatic Cancer; Lumicell Announces U.S. Launch of LumiSystem; Inventia Life Science Introduces RASTRUM™ Allegro to Advance High-Throughput 3D Cell Culture
Norlase Received FDA 510(k) Clearance and CE Mark for LYNX™ Indirect Laser Ophthalmoscope with Pattern Tracking On January 27, 2025, Norlase, a leading global manufacturer of ophthalmic lasers developing next-generation laser solutions, announced the commercial launch and receipt of FDA 510(k) clearance and CE M...
Read More...
Jan 23, 2025
Tempus Launches FDA-Approved xT CDx Test Nationwide; B. Braun Enhances Catheter Securement with the Launch of Clik-FIX; Illuccix® Secures European Regulatory Approval; FDA Clears CapsoCam Plus® for Remote Ingestion; BellaSeno Marks Success in Two Clinical Trials for Revolutionary Breast Implant Technology; AF Symposium to Feature Conformal Medical’s Groundbreaking GLACE Study
Tempus Announced the National Launch of the FDA-Approved xT CDx Test On January 15, 2025, Tempus AI, Inc., a technology company driving the use of AI to advance precision medicine and improve patient care, announced the nationwide launch of its FDA-approved, NGS-based in vitro diagnostic device, xT CDx. Th...
Read More...
Jan 16, 2025
Johnson & Johnson MedTech Secures CE Mark for Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter; Medtronic Secures CE Mark for BrainSense™ Adaptive Deep Brain Stimulation; Inquis Medical Finalizes Enrollment for U.S. Pivotal Study on Aventus Thrombectomy System for Pulmonary Embolism; First Patient Enrolled in Argon Medical’s CLEAN-PE Study for Novel Pulmonary Embolism Therapy; Sutter Health and GE HealthCare Partner to Revolutionize Patient Care with AI-Driven Imaging Solution; Saluda Medical Closes $100M Financing to Expand Neuromodulation Portfolio
Johnson & Johnson MedTech Announced CE Mark Approval for Dual Energy THERMOCOOL SMARTTOUCHTM SF Catheter, Bolstering Capabilities in Cardiac Arrhythmias Treatment On January 10, 2025, Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, announced the receipt of European CE ma...
Read More...
Jan 09, 2025
Roche Secures FDA Clearance for High-Volume Slide Scanner; Pacira Gets 510(k) Approval for Iovera° SmartTip for Chronic Back Pain; ClearCut Presents Clearcoast™ Study Results at San Antonio Breast Cancer Symposium; NanoVibronix Completes UroShield® Pilot Study at University of Michigan; Hologic Finalizes Acquisition of Gynesonics; Movano Health Launches EvieAI Virtual Wellness Assistant.
Roche's Momentum in Digital Pathology Continued With FDA Clearance on its High-Volume Slide Scanner On January 09, 2025, Roche announced that its whole slide imaging system, Roche Digital Pathology Dx, received an additional 510(k) clearance from the United States Food and Drug Administration (FDA). This c...
Read More...
Jan 02, 2025
Genesis Medtech Secures Chinese Approval for Innovative 90° Articulating Stapler; Inogen Secures FDA 510(k) Clearance for SIMEOX 200 Airway Clearance Device; Microtech Unveils First Human Trial of Implantable Microsensor for Heart Failure Monitoring; NAVIGANTIS VASCO™ Platform Begins Clinical Role in Neurovascular Patient Study; Innovent Secures Global Rights from Roche for Novel DLL3 ADC in Exclusive Deal; Treace Expands Portfolio with Percuplasty
Genesis Medtech's World's First 90° Articulation Powered Stapler Achieved Chinese Approval On January 01, 2025, Genesis Medtech announced that iReach Omnia, the world's first powered stapler with 90° articulation capability, received market approval in China from the National Medical Products Administratio...
Read More...
Dec 26, 2024
FDA Grants Approval to Merit Medical’s WRAPSODY Endoprosthesis; FDA Clears AVITA Medical’s Cohealyx, Expanding Treatment Potential; SeaStar Medical Launches 14th Location for Adult AKI Pivotal Study; Contego Medical’s Neuroguard IEP System Treats First Patients; SMT Introduces Hydra™ TAVI System in Russia; SandboxAQ Raises $300M+ to Accelerate AI’s Next Frontier
Merit Medical Announced FDA Approval of the WRAPSODY Cell-Impermeable Endoprosthesis On December 20, 2024, Merit Medical Systems, Inc., a leading global manufacturer and marketer of advanced healthcare technologies, announced that its WRAPSODY® Cell-Impermeable Endoprosthesis received premarket approval (P...
Read More...
Dec 19, 2024
Siemens Healthineers Acquires Molecular Imaging Division from Novartis; BD and Babson Diagnostics Unveil Fingertip Blood Testing for Health Care; Medtronic Completes First Ingestion of Pillcam™ Genius SB Kit; FDA Expands Impella Heart Pump Use to Pediatric Patients; Zimmer Biomet Receives FDA Nod for OsseoFit™ Stemless System; enVVeno Medical Completes Final Implants in Pre-Clinical GLP Study
Siemens Healthineers Acquired Novartis’s Advanced Accelerator Applications Molecular Imaging On December 10, 2024, Siemens Healthineers completed the acquisition of Advanced Accelerator Applications Molecular Imaging from Novartis. This European manufacturing and distribution network specializes in diagnos...
Read More...
Dec 12, 2024
Stereotaxis and Shanghai MicroPort EP Medtech Co., Ltd. Receives Approval for Magbot Robotic Magnetic Navigation Ablation Catheter From China’s NMPA; AngioDynamics NanoKnife® System Approved by FDA for Prostate Tissue Treatment; Zynex Successfully Completes Laser Pulse Oximetry Clinical Trial; COTA, PreciseDx, and Baptist Health Validate AI-Powered PreciseBreast as Equivalent to Oncotype DX; Medtronic Introduces Percept™ RC Rechargeable Neurostimulator; Crown Aesthetics Raises the Bar with the Introduction of SkinPen® Precision Elite
China's NMPA Approved Magbot Robotic Magnetic Navigation Ablation Catheter On December 9, 2024, Stereotaxis and Shanghai MicroPort EP Medtech Co., Ltd., announced that the Magbot™ Magnetic Navigation Ablation Catheter received regulatory approval from China’s National Medical Products Administration (NMPA). T...
Read More...
Dec 05, 2024
FDA Approves Zimmer Biomet’s Oxford® Cementless Partial Knee; ReCerf® Sets Milestone as First All-Ceramic Hip Resurfacing Approved Worldwide; Orthocell Achieves US FDA 510(k) Clearance Milestone for Remplir Regulatory Study; Hologic’s Research Shows AI Breast Imaging Maintains Performance Across All Demographics; GE HealthCare Expands MRI Capabilities with Sonic DL’s Advanced Deep Learning; Terumo Unveils the R2P NaviCross Peripheral Support Catheter
Zimmer Biomet Received FDA Approval for Oxford® Cementless Partial Knee, the Only Cementless Partial Knee Replacement Implant in the U.S. On November 25, 2024, Zimmer Biomet Holdings, Inc., a global leader in medical technology, announced that its Oxford® Cementless Partial Knee received Premarket Approval...
Read More...
Nov 28, 2024
FDA Clears Medtronic’s New Inpen™ App; Zimmer Biomet Gets FDA Approval for Oxford® Cementless Partial Knee; Perimeter B-Series OCT with ImgAssist AI 2.0 Shows Significant Superiority Over Standard-of-Care in Pivotal Clinical Trial; Edwards’ SAPIEN 3 Ultra RESILIA Valve Maintains Exceptional Patient Outcomes in Real-World Settings; Abbott Introduces AVEIR™ VR Leadless Pacemaker System to Indian Market; GE HealthCare’s Pristina Via Transforms Mammography with Improved Workflow and Patient Care
Medtronic Received FDA Clearance for the New Inpen™ App, Paving the Way for its Smart MDI System Launch with Simplera™ CGM On November 20, 2024, Medtronic, a global leader in healthcare technology, announced the U.S. Food and Drug Administration (FDA) clearance for its new InPen™ app, which includes advanc...
Read More...
-Agonist.png "Toll-like Receptors Agonist")
