medical device
Dec 26, 2024
FDA Grants Approval to Merit Medical’s WRAPSODY Endoprosthesis; FDA Clears AVITA Medical’s Cohealyx, Expanding Treatment Potential; SeaStar Medical Launches 14th Location for Adult AKI Pivotal Study; Contego Medical’s Neuroguard IEP System Treats First Patients; SMT Introduces Hydra™ TAVI System in Russia; SandboxAQ Raises $300M+ to Accelerate AI’s Next Frontier
Merit Medical Announced FDA Approval of the WRAPSODY Cell-Impermeable Endoprosthesis On December 20, 2024, Merit Medical Systems, Inc., a leading global manufacturer and marketer of advanced healthcare technologies, announced that its WRAPSODY® Cell-Impermeable Endoprosthesis received premarket approval (P...
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Dec 19, 2024
Siemens Healthineers Acquires Molecular Imaging Division from Novartis; BD and Babson Diagnostics Unveil Fingertip Blood Testing for Health Care; Medtronic Completes First Ingestion of Pillcam™ Genius SB Kit; FDA Expands Impella Heart Pump Use to Pediatric Patients; Zimmer Biomet Receives FDA Nod for OsseoFit™ Stemless System; enVVeno Medical Completes Final Implants in Pre-Clinical GLP Study
Siemens Healthineers Acquired Novartis’s Advanced Accelerator Applications Molecular Imaging On December 10, 2024, Siemens Healthineers completed the acquisition of Advanced Accelerator Applications Molecular Imaging from Novartis. This European manufacturing and distribution network specializes in diagnos...
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Dec 12, 2024
Stereotaxis and Shanghai MicroPort EP Medtech Co., Ltd. Receives Approval for Magbot Robotic Magnetic Navigation Ablation Catheter From China’s NMPA; AngioDynamics NanoKnife® System Approved by FDA for Prostate Tissue Treatment; Zynex Successfully Completes Laser Pulse Oximetry Clinical Trial; COTA, PreciseDx, and Baptist Health Validate AI-Powered PreciseBreast as Equivalent to Oncotype DX; Medtronic Introduces Percept™ RC Rechargeable Neurostimulator; Crown Aesthetics Raises the Bar with the Introduction of SkinPen® Precision Elite
China's NMPA Approved Magbot Robotic Magnetic Navigation Ablation Catheter On December 9, 2024, Stereotaxis and Shanghai MicroPort EP Medtech Co., Ltd., announced that the Magbot™ Magnetic Navigation Ablation Catheter received regulatory approval from China’s National Medical Products Administration (NMPA). T...
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Dec 05, 2024
FDA Approves Zimmer Biomet’s Oxford® Cementless Partial Knee; ReCerf® Sets Milestone as First All-Ceramic Hip Resurfacing Approved Worldwide; Orthocell Achieves US FDA 510(k) Clearance Milestone for Remplir Regulatory Study; Hologic’s Research Shows AI Breast Imaging Maintains Performance Across All Demographics; GE HealthCare Expands MRI Capabilities with Sonic DL’s Advanced Deep Learning; Terumo Unveils the R2P NaviCross Peripheral Support Catheter
Zimmer Biomet Received FDA Approval for Oxford® Cementless Partial Knee, the Only Cementless Partial Knee Replacement Implant in the U.S. On November 25, 2024, Zimmer Biomet Holdings, Inc., a global leader in medical technology, announced that its Oxford® Cementless Partial Knee received Premarket Approval...
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Nov 28, 2024
FDA Clears Medtronic’s New Inpen™ App; Zimmer Biomet Gets FDA Approval for Oxford® Cementless Partial Knee; Perimeter B-Series OCT with ImgAssist AI 2.0 Shows Significant Superiority Over Standard-of-Care in Pivotal Clinical Trial; Edwards’ SAPIEN 3 Ultra RESILIA Valve Maintains Exceptional Patient Outcomes in Real-World Settings; Abbott Introduces AVEIR™ VR Leadless Pacemaker System to Indian Market; GE HealthCare’s Pristina Via Transforms Mammography with Improved Workflow and Patient Care
Medtronic Received FDA Clearance for the New Inpen™ App, Paving the Way for its Smart MDI System Launch with Simplera™ CGM On November 20, 2024, Medtronic, a global leader in healthcare technology, announced the U.S. Food and Drug Administration (FDA) clearance for its new InPen™ app, which includes advanc...
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Nov 21, 2024
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
Cartessa Aesthetics Partnered With Classys, Inc. to Bring Everesse to the US Market On November 14, 2024, Cartessa Aesthetics, a leading North American aesthetic medical device company, collaborated with Classys, Inc., a prominent global aesthetics firm based in South Korea, to introduce EVERESSE by Volnew...
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Nov 14, 2024
FDA Grants Approval to Caris Life Sciences for MI Cancer Seek; Johnson & Johnson MedTech Secures FDA IDE Approval for OTTAVA; Organogenesis Shares Positive Interim Data from Second Phase 3 Study of ReNu; LivaNova’s OSPREY Trial Achieves Key Safety and Efficacy Milestones; Hyperfine Launches Advanced Portable MR Brain Imaging Swoop® System Across Europe; Nihon Kohden Strengthens Neurological Solutions Through Ad-Tech Medical Instrument Corporation Acquisition
Caris Life Sciences Received FDA Approval for MI Cancer Seek™ as a Companion Diagnostic (CDx) Test On November 6, 2024, Caris Life Sciences, a leading next-generation AI TechBio company and precision medicine pioneer, announced that the U.S. Food and Drug Administration (FDA) approved MI Cancer Seek™ for u...
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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 24, 2024
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
iRhythm Technologies Received FDA 510(k) Clearance for Design Updates Previously Made to Its Zio® AT Device On October 21, 2024, iRhythm Technologies, Inc., a leading digital healthcare company specializing in solutions to detect, predict, and prevent disease, announced that the U.S. Food and Drug Administ...
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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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