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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Okami Medical Secures Expanded Indication for LOBO Vascular Occluder; CraniUS Therapeutics Secures Second FDA 510(k) Clearance in Six Weeks and U.S. Patent for NeuroPASS™ 3; Danaher Accelerates Life Sciences Research with New AI-Powered Autonomous Lab; Aesthetic Brokers Advises SDBotox on Strategic Partnership; BD Advances Peripheral Vascular Innovation with Positive AGILITY Trial Results; Sonorous Neurovascular Secures FDA IDE Approval for Pivotal U.S. Trial of Venous Sinus Stent in Pulsatile Tinnitus

Okami Medical Received Expanded Indication for the LOBO Vascular Occluder On 07 October 2026, Okami Medical received an expanded FDA indication for its LOBO Vascular Occlusion System, extending the device's application from peripheral arterial procedures to peripheral venous embolization. The expanded indication broadened the potential use of the device for treating venous conditions, including pelvic venous disease and portal hypertension. The LOBO Vascular Occluder was developed as a mechanical embolization device for controlled and reliable vessel occlusion. Its proprietary HDBRAID technology was designed to provide a high-density, small-pore structure that supp...

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UTR Therapeutics’ UTRxMYCN M1-14 Granted FDA Orphan Drug and Rare Pediatric Disease Designations; Medtronic Announces Regulatory Milestones for New Cardiac Mapping and Ablation Software; Abbott Adds SimpleScreen™ CRC Blood Test to Colorectal Cancer Screening Portfolio; VEMERIX Introduces Patented Single-Use Ultrasound Puncture Kit With Customized Probe Compatibility; Avisi Technologies to Showcase Two-Year VisiPlate® Results at AAO Annual Meeting; FIRE1 Implants First Patient in NORM-HF Pivotal Trial for Innovative Heart Failure Management

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Ferronova Announces Preliminary MAGMAP Results in 62-Patient Gastric and Oesophageal Cancer Trial; Powerful Medical Secures FDA De Novo Authorization for AI ECG Model; ZEISS Advances Cataract Surgery with Introduction of AT LUCIA toric 721P; Waters Launches BD FACSDiscover A7 Cell Analyzer for Standardized Spectral Flow Cytometry; Nicklaus Children’s Hospital Completes One of the Country’s First Transcatheter Fontan Procedures in a Two-Year-Old

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Emboline Secures FDA 510(k) Clearance for Emboliner® Embolic Protection System; Alcon’s Clareon Monofocal IOL Secures EU MDR Certification from TÜV SÜD; Shoulder Innovations Enters Exclusive Partnership with ALM Ortho for Complex Shoulder Reconstruction Solutions; Avo Expands MEDITECH Alliance, Bringing Full Suite of AI Solutions to EHR; Nicklaus Children’s Hospital Performs Pioneering Transcatheter Fontan Completion in Two-Year-Old Child; AEYE Health Publishes AEYE-DS Clinical Trial Results Demonstrating High Diagnostic Accuracy and >99% Imageability

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Spineart’s PERLA® TL Application Receives FDA 510(k) Clearance for eCential Robotics’ Op.n® Platform; Alcon’s Clareon Monofocal IOL Earns EU MDR Certification; BTL Expands Into Laser Technology With New Division and EXOLASE ONE; Stryker, IAGE Collaborate to Enhance Fluorescence-Guided Surgery Training in India; Galmed Announces Positive First-in-Human Results for Colospan’s Novel Tissue Assessment Platform; FastWave Medical Secures FDA IDE Approval for Pivotal Artero Peripheral IVL Trial

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Spineart and eCential Robotics Gain FDA Clearance for PERLA® TL Robotic Surgery Application; ZEISS CLINIC 360 Earns FDA 510(k) Clearance, Strengthening Data-Driven Patient Care; Bittium Introduces Faros Pro™ and EasyFlex™ for Extended Ambulatory ECG Monitoring; Cytrellis Expands ellacor® Micro-Coring® Technology to Australia for Full-Body Skin Resurfacing; Galmed Announces Successful First-in-Human Study of Colospan’s Novel Tissue Assessment Technology; FastWave Medical Secures FDA IDE Approval for Pivotal Artero™ Peripheral IVL Trial

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Empatica Secures FDA Clearance for Parkinson’s Monitoring; ZEISS CLINIC 360 Secures FDA 510(k) Clearance; BioLab Holdings Strengthens Tissue Restoration Portfolio With Addition of FastSkin® Technology; Surity™ Expands Urinary Incontinence Care Portfolio with New At-Home Urinary Management System; Galmed Announces Positive First-in-Human Proof-of-Concept Results for Colospan’s Intraoperative Tissue Assessment Platform; FastWave Medical Secures FDA IDE Approval for Pivotal Artero™ Peripheral IVL Trial

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Sobi Partners with Innate Pharma to License Lacutamab for T-Cell Lymphoma; Yochanra Makes Global Debut in China as First Innovative Drug Designed to Overcome FGFR Inhibitor Resistance; Replimune Secures FDA Accelerated Approval for TUDRIQEV Plus Nivolumab in Advanced Cutaneous Melanoma; FDA Accepts Supplemental Biologics License Application for ENFLONSIA to Broaden RSV Indication in Young Children; Tarsus Pharmaceuticals to Acquire Alkeus Pharmaceuticals

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Ultomiris Phase III Trial Update Highlights Progress in Post-Transplant TMA; argenx Acquires Forte Biosciences; Otsuka’s SIMTRIYO Receives FDA Nod as a First-in-Class ADHD Treatment; Outlook Therapeutics Secures FDA Approval for LYTENAVA to Treat Wet AMD; Merck Reveals Future Access Strategy for Once-Monthly Oral HIV Prevention Therapy Alimatravir

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Zymeworks Announces Acquisition of Theravance Biopharma; Ipsen to Acquire Kartos Therapeutics; Viridian Therapeutics Wins U.S. FDA Approval for Lumvoa; Replimune Reaches FDA Milestone with RP1 BLA Resubmission Acceptance; Epicrispr Announces Encouraging Clinical Data for EPI-321 in FSHD

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Olympus Secures FDA Clearance for POWERSEAL™ Open Extended Jaw Device; Abbott’s Ultreon™ 3.0 Receives FDA Clearance and CE Certification; LTS Broadens CDMO Capabilities with Ophthalmic Drug Delivery Expertise; BD Transforms Central Line Placement with Groundbreaking Technology; AI Models Deliver Up to 73% Fewer Genome Analysis Errors in New Research; Calidar Finishes Enrollment in First-in-Human Trial of 4D Mammography System

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Unlocking Growth Potential in the Presbyopia Treatment Market: Innovations Reshaping Age-Related Vision Loss

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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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Top 8 Breakthrough Gene Therapies for Retinitis Pigmentosa Treatment

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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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Sana Biotechnology Reveals Long-Term Positive Data from Type 1 Diabetes Islet Cell Transplant Trial; Bayer’s Finerenone Demonstrates Efficacy in Phase III FIND-CKD Study in Non-Diabetic CKD Population; Immutep Halts Phase III NSCLC Trial; REGENXBIO’s RGX-202 Demonstrates Promising Interim Results in Phase I/II AFFINITY DUCHENNE Trial; Ultragenyx’s DTX301 Gene Therapy Delivers Positive 36-Week Phase 3 Data

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Pilatus Biosciences Advances PLT012 Into the Clinic Following FDA IND Clearance; ENHERTU + pertuzumab Receives US Approval as the First New First-line Option in a Decade for HER2-positive Metastatic Breast Cancer; Sanofi Reports on Tolebrutinib Development in Primary Progressive MS; Gilead Reports Positive Phase 3 Results for Bictegravir–Lenacapavir Investigational HIV Therapy; argenx Announces Study Update for UplighTED Program of Efgartigimod SC in Thyroid Eye Disease

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