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Notizia - Recent Pharma, Healthcare and Biotech Happenings

STARMED Secures FDA 510(k) Clearance for Benign Thyroid Nodule Ablation; SciBase Advances U.S. Expansion with FDA 510(k) Submission for Nevisense; ALR Technologies to Acquire CGM Medical Technology in US$45 Million and 200 Million Share Deal; Co-Diagnostics Completes Validation Studies Ahead of FDA 510(k) Submission for Upper Respiratory Point-of-Care Test; Corvention Launches Innovative Balloon Catheter in the U.S. Following First Clinical Case; OrthAlign Reports First Clinical Cases Using Lantern® ASC System

STARMED Received FDA 510(k) Clearance for a Benign Thyroid Nodule Ablation Indication On 01 July 2026, STARMED America announced that it had received FDA 510(k) clearance for the first radiofrequency ablation (RFA) system in the United States specifically indicated for the treatment of benign thyroid nodules. The clearance made STARMED the first and, at the time, the only company in the U.S. to receive an FDA indication for thyroid nodule RFA, representing a major milestone in the adoption of minimally invasive thyroid treatments. The FDA-cleared indication covered the company's VIVA combo RF Generator, STARMED RF Electrodes, and VIVA RF Electrodes for ultrasoun...

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Waters Receives FDA Approval for Advanced HPV Self-Collection and Testing Kit; MedCAD Achieves FDA 510(k) Clearance for AccuStride® Tib/Fib Anatomical Solution; Mercy Medical Center Expands IBD Care with Office-Based Intestinal Ultrasound; BD Introduced Next-Generation TIPS Innovation to Enhance Portal Hypertension Care in the European Union; KingstronBio Completes First ProStyle M® Mitral Valve Implant in Confirmatory Trial; MiRus Launches Enrollment for STAR Randomized Study of Siegel™ TAVR System

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Acute Ischemic Stroke Treatment and Diagnosis Devices: Technologies Transforming Stroke Care

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Restore Robotics Secures FDA 510(k) Clearance for Two New da Vinci Xi® Instruments; Medtronic Wins FDA Approval for OmniaSecure™ Defibrillation Lead Enabling Conduction System Pacing; Bebird Introduces EarSight Ultra; BD Introduces AI-Driven Medication Dispensing System in Europe; i-Lumen Scientific Secures FDA IDE Approval to Launch U.S. Enrollment for i-SIGHT2 Dry AMD Trial; Belay Diagnostics Highlights 82% Clinical Impact Rate in CNS Lymphoma Evaluation

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AI Integration in Radiopharmaceuticals: Transforming Precision Diagnostics and Targeted Therapy

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LiviWell Receives FDA Clearance for Livi, Pioneering Post-Intercourse Vaginal Care; Medtronic Advances Spine and Cardiac Care with ViaVerte Partnership and FDA Approval of OmniaSecure Lead; ZEISS Broadens Its Ophthalmic Workflow Portfolio in Canada; Starlight Cardiovascular Reports First-Ever Infant Treated with Lifeline Stent System at Cincinnati Children’s Hospital; Belay Diagnostics Highlights 82% Clinical Impact Rate for Summit™ and Vantage™ in CNS Lymphoma

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Molecular Diagnostics: Bridging the Gap Between Diagnosis and Treatment

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MiniMed Secures FDA Clearance for MiniMed Flex; Spinal Elements Expands Portfolio with FDA-Cleared Ventana® Platform and Initial ALIF Launch; Mindray North America Strengthens Respiratory Care Offering Through Ventilator Market Entry; Micro-Tech Endoscopy Enters Definitive Deal to Acquire Key GI Product Lines from CONMED; Composite Manufacturing Inc. Unveils Study Showing NekSpine® Exoskeleton Eases Neck and Back Load During Simulated Surgeries; SkinVision Partners on Landmark Trial to Expand Dermatology Care Access in the U.S.

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Defibrillators at the Heart of Cardiac Care: Challenges, Innovations, and the Road Ahead

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QT Imaging Secures FDA Clearance for Enhanced Breast Acoustic CT Scanner Configuration; LifeVac Secures FDA Authorization as the First and Only Anti-Choking Device; Smith+Nephew Introduces Next-Generation ALLEVYN COMPLETE CARE Foam Dressing for Enhanced Wound Management; Olympus Corporation Debuts Next-Gen Surgical Visualization Platform in the U.S.; IceCure Medical Receives FDA Approval for Post-Marketing ‘CHOICE’ Study of ProSense Cryoablation System; Envoy Medical Concludes Enrollment for Landmark Trial of Fully Implanted Cochlear Implant

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Companion Diagnostics in Healthcare: Powering the Era of Precision Medicine

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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

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Foot and Ankle Devices: Transforming Orthopedic Care Through Innovation

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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

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Electrophysiology Devices: The Future of Cardiac Arrhythmia Management

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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

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Diabetes Care Devices: Transforming Management Through Innovation and Precision

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