MedTech Market
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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Nov 07, 2024
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
Beta Bionics Launched iLet Bionic Pancreas Along With Abbott’s FreeStyle Libre 3 Plus sensor On October 30, 2024, Beta Bionics, Inc., a leader in developing advanced diabetes management solutions, announced the launch of its iLet Bionic Pancreas and its integration with Abbott’s FreeStyle Libre® 3 Plus sen...
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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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Oct 10, 2024
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
Johnson & Johnson Completed Acquisition of V-Wave On Oct 09, 2024, Johnson & Johnson announced that it successfully completed the acquisition of V-Wave Ltd., a privately-held company dedicated to developing innovative treatments for heart failure patients. V-Wave will now operate under Johnson & John...
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