Cardiac Ablation Devices
May 01, 2025
Medtronic Receives FDA Approval for OmniaSecure™ Lumenless Defibrillation Lead and Presents Positive Clinical Trial Results for Hugo™ Robotic-Assisted Surgery System; Roche’s AI Companion Diagnostic for NSCLC Earns FDA Breakthrough Device Designation; Boston Scientific Announces Positive 12-Month Phase 2 Results from ADVANTAGE AF Trial of FARAPULSE™ PFA System; Bausch Health Launches Fraxel FTX™ to Advance Skin Rejuvenation Treatments; Gestalt Diagnostics Secures $7.5M in Series A to Scale AI Pathology Solutions
Medtronic Received FDA Approval for Smallest-Diameter, Lumenless Defibrillation Lead, the Omniasecure™ Lead and Published Investigational Clinical Study Results, Offering New Therapy Option for Heart Rhythm Disorders On April 25, 2025, Medtronic plc., a global leader in healthcare technology, received U.S....
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Apr 03, 2025
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.
Abbott Received CE Mark for Volt™ Pulsed Field Ablation System, Offering New Therapy Option for Heart Rhythm Disorders On March 27, 2025, Abbott announced that it received the CE Mark in Europe for its VoltTM Pulsed Field Ablation (PFA) System, designed to treat patients with atrial fibrillation (AFib). Th...
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Mar 06, 2025
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
ABANZA Received FDA 510(k) Clearance for WasherCap™ Mini Implantable Fixation Device, Advancing Soft Tissue Repair Solutions On February 26, 2025, ABANZA, a leader in advanced soft tissue repair solutions announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its innovative...
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Feb 20, 2025
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
Neonav® ECG Tip Location System Received FDA 510(k) Clearance to Improve Pediatric Vascular Access Care On February 16, 2025, Navi Medical Technologies, a leader in pediatric healthcare innovation, announced that its Neonav® ECG Tip Location System received 510(k) clearance from the U.S. Food and Drug Admi...
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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...
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Oct 31, 2024
Medtronic Secures FDA Green Light for Affera™ Mapping and Ablation System Alongside Sphere-9™ Catheter; Precision Optics Gets FDA 510(k) Clearance; Abbott Launches New Clinical Trial Aimed at Enhancing Care for Advanced Heart Failure Patients; Fresenius Medical Care’s Study Confirms Efficacy of New Anemia Therapy Software in Enhancing Outcomes for Hemodialysis Patients; Inspira™ Announces New Distribution Center to Support INSPIRA™ ART100’s U.S. Introduction; WellSky Expands Home Care Offerings with Acquisition of Bonafide
Medtronic Received FDA Approval for Affera™ Mapping and Ablation System and Sphere-9™ Catheter, Pioneering Advances in Arrhythmia Treatment On October 24, 2024, Medtronic plc, a global leader in healthcare technology, announced the United States Food and Drug Administration (FDA) approval of its Affera™ Ma...
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Oct 17, 2024
Roche Receives FDA Approval for Itovebi; FDA Approves Bausch + Lomb’s Envista® Envy™; Microbot Medical Successfully Completes Pivotal Human Clinical Trial and Accelerates Go-to-Market Strategy for LIBERTY® Launch; Positive FDA Guidance on Phase III Trial of 64Cu-SAR-Bispsma for Recurrent Prostate Cancer; ELEHEAR Launches Hearing Aids at Just $399; Abbott Advances Pulsed Field Ablation Studies and Launches New Technology for Cardiac Mapping
FDA Approved Roche’s Itovebi, a Targeted Treatment for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation On October 11, 2024, Roche announced that the United States Food and Drug Administration (FDA) approved Itovebi™ (inavolisib), in combination with palbociclib (Ibran...
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Jan 11, 2024
Medtronic Announced World’s First Approval for MiniMed 780G System; CE Mark for Medtronic’s Next Generation Micra Leadless Pacing Systems; Biosense Webster Received Approval for VARIPULSE PFA Platform; Rivermark Medical Updated on Flostent System; Cala Disclosed TAPS Therapy Data for Essential Tremor; Medline Introduced Transparent Wound Dressing
Medtronic Received CE Mark for its Next Generation Micra Leadless Pacing Systems On January 5, 2024, Medtronic announced that the Micra AV2 and Micra VR2, the next generation of its industry-leading tiny, leadless pacemakers, earned the CE (Conformité Européenne) Mark. The world's tiniest pacemakers, the rMic...
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Sep 01, 2022
Miracor Medical’s Picso Pivotal Study; Medtronic’s Extravascular ICD; Galaxy Medical’s CENTAURI Pulsed Electric Field System; UltraSight’s Novel Cardiac AI Technology; Oticon Launched the World’s Smallest Hearing Aid; Medtronic Completes Acquisition of Affera
FDA Approved IDE for Picso® Pivotal Study of Miracor Medical On August 23, 2022, Miracor Medical SA, a provider of innovative solutions for the treatment of severe cardiac diseases, announced that the FDA has approved an Investigational Device Exemption (IDE), allowing the company to begin a pivotal study with i...
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Aug 25, 2022
Edwards’s Pascal Precision System; Abbott’s New Spinal Cord Stimulation Device; Imagin to Acquire enCAGE Coil Precision Ablation System; Boston Heart Diagnostics Launches LipidSeqTM; Rocket VR Health Partners with Penn Medicine’s Abramson Cancer Center; Thermedical’s Clinical Trial to Treat Ventricular Tachycardia
Edwards Pascal Precision Transcatheter Mitral And Tricuspid Valve Repair System Receives CE Mark On August 17, 2022, Edwards Lifesciences Corporation, an American medical technology company headquartered in Irvine, California, specializes in artificial heart valves and hemodynamic monitoring. The company announc...
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