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Cardiovascular Diseases

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Cartessa Aesthetics teams with Classys for Everesse; LogicMark unveils Freedom Alert Max; GE HealthCare clears SIGNA MAGNUS MRI; OMRON’s BP monitor with AI-powered AFib detection gets FDA approval; Boston Scientific’s WATCHMAN FLX™ cuts bleeding risk; Encora Therapeutics wraps ULTRE trial for tremor device

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Beta Bionics Introduces iLet Bionic Pancreas with Abbott’s FreeStyle Libre 3 Integration; Merit Medical Successfully Acquires Cook Medical’s Lead Management Portfolio; Elixir Medical’s LithiX HC-IVL System Maintains Safety and Efficacy at Six-Month Mark; Philips Launches U.S. Clinical Trial with First Patient Enrolled for New Integrated Device for PAD; FDA Grants iRhythm Technologies 510(k) Clearance for Enhanced Zio AT Device; SeeMedX Submits 510(k) for Cardiac Monitoring System Aiming to Revolutionize Heart Failure Management

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6 Groundbreaking Applications of Organoids That Are Changing Healthcare

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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

medtech-news-for-endospan-boston-scientific-ge-healthcare

iRhythm’s Zio® AT Device Improvements Receive FDA Clearance; Epitel Adds REMI AI Device to Portfolio with Fourth FDA 510(k); SeaStar Medical Advances Acute Kidney Injury Trial, Approaches Interim Analysis; Endospan Completes Primary Enrollment for TRIOMPHE Study of NEXUS® Stent Graft; Boston Scientific Enhances FARAPULSE™ PFA with New Cardiac Mapping Technology; GE HealthCare Debuts CareIntellect to Support Oncologists with AI-Enhanced Patient Insights

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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

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Johnson & Johnson Acquires V-Wave; CalmiGo Launches Anxiety-Management Platform CalmiGo Plus; Vy Spine Secures FDA Clearance for 3D-Printed Lumbar IBF; InspireMD Receives IDE Approval for CGuard Stent Study; GE Healthcare Reveals Phase I MRI Contrast Results; Medinol Completes First Human Implantation of Drug-Eluting Stent

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Establishment Labs Gains FDA Approval for Motiva Implants; Surmodics Receives 510(k) Clearance for Pounce™ XL Thrombectomy System; Synergy Spine Solutions Completes Patient Enrollment in Synergy Disc® 2-Level IDE Clinical Trial; Medtronic Reports Strong Lesion Durability Data for PulseSelect™ Ablation System and Expands AiBLE™ Spine Surgery Ecosystem with Siemens Healthineers Partnership; Globus Medical Launches New Orthopedic Trauma Solutions

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Boston Scientific INGEVITY™ gets Expanded Indication and acquires Silk Road Medical; FDA Approves Philips’ LumiGuide Guidewire; Microbot Completes LIBERTY Trial Enrollment; Innovent Presents Data at ESMO 2024; Argon Medical Launches CLEANER Vac™ System

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SpectraWAVE raised $50M; Rockwell Medical signed dialysis deal; Modular Medical got FDA nod for Modd1 pump; iRhythm’s Zio approved in Japan; Autonomix trial showed 83% pain reduction; Insulin Efsitora Alfa improved A1C.

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Bayer Phase III NSCLC Trial; D&D Pharmatech Gets FDA Nod for GLP-1R Agonist in Multiple Scletosis; Merck Halts Two KEYTRUDA Trials; Novartis Expands LEQVIO After Phase III Success; Alnylam Reports Strong Phase III Data for Vutrisiran

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Insulet Corporation’s Omnipod® 5 Automated Insulin Delivery System Receives FDA Approval; FDA Gives Green Light to Expand Vericel’s MACI Arthro Label; SkinCure Oncology Announces New Study of Non-melanoma Skin Cancer Through Image-guided Superficial Radiation Therapy; SDC’s BYOD ePRO Solution Clinical Trial; PaceMate® Acquires Paceart Optima™ System; KARL STORZ Acquires a US-headquartered Company

Pharma-news-for-merck-pfizer-novartis

Merck’s WINREVAIR™ EU Approval; BALVERSA for Urothelial Carcinoma; Novartis and Versant’s Borealis Launched; Moderna’s RSV mRESVIA® EU Approval; FDA Nods RYBREVANT® and LAZCLUZE™ for EGFR-mutated Lung Cancer

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MIMEDX Launches HELIOGENTM Fibrillar Collagen Matrix; DocGo Launches Mobile X-ray Program; Labcrop’s FDA De Novo Marketing Authorization; Inspire Medical Systems Receives FDA Approval; Alcyone Therapeutics Announces Continued Enrollment Approval from the FDA; Lunit’s AI for Tuberculosis Detection

medtech-news-for-stryker-vialase-diamyd-medical

Stryker’s Spine Guidance 5 Software FDA Approval; VIALASE Received CE Mark; The Texas Heart Institute Implanted the BiVACOR® Total Artificial Heart; Diamyd Medical’s Phase 3 Trial Positive Results; Cardio Diagnostics Holdings Inc.’s CDIO.AI; GE Healthcare and AWS Strategic Collaboration

medtech-news-for-inspira-oticon-medical-spineguard

Inspira™ Approval of INSPIRA™ ART100 System; Oticon Medical’s Sentio™ System Received Regulatory Clearance; SpineGuard Filed its “510K” Dossier in the US; Vectorious Medical Technologies’ V-LAP Left Atrial Pressure Sensor Successful Implantation; Bedal International Raised $11 Million; Mytonomy Inc. Agreement With Vizient, Inc.

medtech-news-for-cordis-forma-medical-virpax

Cordis FDA Approval for MYNX CONTROL VENOUS Vascular Closure Device;  Forma Medical’s Optimal Plating System FDA Approval; Virpax’s Swine Model Pilot Study Positive Results; SetPoint Medical Positive Topline Results from Pioneering RESET-RA Study; Signature Orthopaedics Partnered with THINK Surgical; Nusano and PharmaLogic Formed Strategic Supply Agreement

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