Cardiovascular Diseases

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ACC.25 Highlights: Groundbreaking Advances in Cardiovascular Medicine and Emerging Therapeutics

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Edwards’ SAPIEN M3 Becomes First Transfemoral TMVR System to Receive CE Mark; Terumo Neuro Receives FDA Clearance for Carotid Stent System; Microbot Medical Reports Complete Robotic Navigation Success in LIBERTY® System Pivotal Trial; J&J MedTech Marks Milestone with First OTTAVA™ Robotic Surgeries; Baxter Introduces Room-Temperature Hemopatch for Faster Surgical Hemostasis; Merit Medical Introduces the Ventrax™ Delivery System

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Non-Surgical Body Contouring: What’s Fueling Its Growth in Aesthetic Medicine?

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Abbott Secures CE Mark for Volt™ Pulsed Field Ablation System and Unveils TRILUMINATE™ Trial Data on TriClip™ for Tricuspid Valve Repair; Zimmer Biomet’s RibFix Advantage® Fixation System Earns CE Mark; Teleflex Announces Initial Clinical Data from IDE Study Evaluating Ringer™ PBC in Coronary Perforation Treatment; GE HealthCare Launches Revolution™ Vibe CT, Bringing Unlimited One-Beat Cardiac Imaging and AI Solutions; TELA Bio Launches Larger OviTex® PRS Sizes in the U.S.

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Alcon Gains CE Mark for Clareon Vivity IOL in Europe; MicroPort MedBot’s Toumai SP Robot Wins NMPA Approval; Abbott Launches Intravascular Lithotripsy Trial; BD Advances GalaFLEX LITE™ Clinical Trial; GE HealthCare Unveils AI-Powered Invenia ABUS Premium; Okami Medical Introduces SENDERO® MAX Catheter

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Caristo Wins FDA Clearance for AI Solution to Prevent Heart Attacks; Lindus Health and Sooma Medical Announce Key Clinical Trial for MDD Device; GT Metabolic Secures FDA Clearance for Expanded 50mm MagDI System; Beckman Coulter’s DxC 500i Integrated Analyzer Earns FDA Clearance for Enhanced Diagnostics

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Roche’s TNKase — First New Acute Ischemic Stroke Drug in Nearly 30 Years

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ABANZA Secures FDA 510(k) Clearance for WasherCap™ Mini; Cerus Corporation Secures CE Mark for Next-Gen INTERCEPT Illumination Device; Spinal Stabilization Technologies Enrolls First U.S. Patient in IDE Trial for PerQdisc™; Inspira Technologies Reports Positive Clinical Results for AI-Integrated HYLA Blood Sensor; iCAD and RamSoft Partner to Expand ProFound AI Mammography Solutions in North America; Pulnovo Medical Secures Nearly $100M in Series C Funding

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FDA Grants 510(k) Clearance to Neonav® ECG Tip Location System; ClearPoint Neuro Secures EU MDR Certification for SmartFlow Cannula; Volta Medical’s AI-Driven Ablation Procedure Improves Outcomes in Persistent Atrial Fibrillation Trial; WhiteSwell Presents New Clinical Data on eLym System for Acute Heart Failure Treatment; J&J MedTech Introduces CEREGLIDE™ 92 Catheter System; Thermo Fisher Launches New Spatial Imaging System for Tissue Proteomics

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Bioretec Ltd. Gains CE Mark for RemeOs™ Trauma Screw; HoneyNaps’ AI Sleep Diagnostic Software Achieves Recognition as the 73rd and 74th Innovative Medical Devices by South Korea’s MFDS; Movano Health Advances Clinical Trials for Innovative Non-Cuff Blood Pressure Monitor; IRB Approves PathMaker Neurosystems’ MyoRegulator® ALS Study; Aspen Medical Products Closes Deal to Acquire Advanced Orthopaedics; Surmodics Achieves Early Clinical Success with Pounce™ XL Thrombectomy System

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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

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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

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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

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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

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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

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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

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FDA Grants Fast Track for Lin BioScience’s LBS-007; Alnylam’s AMVUTTRA sNDA Under Review; FDA Approves RAPIBLYK for Atrial Fibrillation; Applied Therapeutics Receives CRL for Govorestat in Galactosemia; R289 Gets Fast Track for Lower-Risk MDS.

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