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Cardiovascular Diseases

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

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 (Ibrance®) and fulvestrant, for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence after completing adjuvant endocrine therapy. The PIK3CA mutation ...

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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

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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

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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.

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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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The Rise of Energy Drinks: Power in a Can or a Health Hazard?

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Eisai Announces Solo Development of Farletuzumab Ecteribulin (FZEC); Johnson & Johnson’s Nipocalimab Phase III Trial; Merck’s WINREVAIR EU CHMP Recommendation; Verona Pharma’s Ohtuvayre FDA Approval; AstraZeneca’s Lynparza and Imfinzi EU Approval

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Alnylam’s HELIOS-B Phase III Study of Vutrisiran; Bristol Myers Squibb Secures FDA Nod for KRAZATI and Cetuximab; Daichii Sankyo’s EZHARMIA® Receives Japan Approval; Vertex’s Phase I/II VX-880 Trial; argenx’s VYVGART Hytrulo FDA Approval

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Revolutionizing Dilated Cardiomyopathy Treatment: The Road Ahead

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Boston Scientific Corporation Agreement to Acquire Silk Road Medical; Philips Introduced Duo Venous Stent System; Akili’s EndeavorOTC Received FDA Clearance; Roche Achieved FDA Clearance; atHeart Medical Reported Long and Short-term Clinical Data; Bioretec Announced Successful Clinical Outcomes

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WINREVAIR Approval for Pulmonary Arterial Hypertension Treatment: Is It A Game-Changer for Merck?

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Asensus Surgical Acquired by Karl Storz; Allosource® Launched Aceconnex®; Siemens Healthineers FDA Clearance for Chiller-Free Biograph Trinion PET/CT; Abbott Received FDA Clearance; Foldax® Reported Positive Clinical Results; Amber Implants Completed Enrolment of First-In-Human Clinical Trial

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Solis Mammography’s Acquisition of MUSIC Imaging Center; Nikon’s SI-PH Phase Condenser Accessory Option; Teijin Launch Surgical Patch; Terumo Cardiovascular’s FDA 510(K) Clearance; Spineart’s 510(k) Clearance; Ceretrieve’s Success in FIH Ischemic Stroke Cases

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From Lab to Lifesaver: Advancing Artificial Blood Vessels for Healthier Tomorrows

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Laborie’s Enhanced Gastrointestinal Diagnostics; Carestream’s Image Suite MR 10 Software Launch; Implicity’s Heart Failure Algorithm FDA 510(k) Approval; AngioDynamics’ AlphaVac F1885 System CE Mark Approval; HeartBeam’s Artificial Intelligence Algorithm for Arrhythmias; Onward ARC-EX Nerve Stim Hit Pivotal Trial

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Nanomedicine Market: Evaluating the Pioneering Innovations and Future Growth Prospects

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Xtant Medical’s SimipliGraft TM and SimpliMaxTM Launch; Perelel’s Fertility Support Products Expansion; Medtronic’s InceptivTM FDA Approval; GE Healthcare’s Vital Signs Monitor FDA 510(K) Clearance; Merck’s Pneumonia Vaccine Positive Results; Artivion’s Aortic Devices AATS Win

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