Cardiac monitoring devices
Apr 23, 2026
Utepreva Announces FDA 510(k) Clearance for Endometrial Sampler Aimed at Early Cancer Detection; Sonorous Neurovascular Announces FDA 510(k) Clearance of BosCATH Neurovascular Catheter; OrganaBio and RxMP Therapeutics Partner to Support Manufacturing of RMP-402 Hemostatic Therapy; RhythMedix Introduces the New RhythmStar® SL Advanced Cardiac Monitor; Nicklaus Children’s Hospital Achieves First Traveling Bedside PDA Closure in Fort Lauderdale NICU; RIVANNA Advances Multi-center Clinical Study of Accuro XV Musculoskeletal Imaging System
Utepreva Introduced FDA 510(k)-Cleared Endometrial Sampler Designed to Support Early Detection of Endometrial Cancer On 22 April 2026, Utepreva LLC announced the launch of the Utepreva Endometrial Sampler, a patented, FDA 510(k)-cleared, single-use endometrial sampling device designed to enhance tissue capture a...
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Mar 05, 2026
Abbott’s New CardioMEMS™ Remote Monitoring Reader Gains FDA Approval; Mobia Medical and Sanford Health Secure FDA Approval for Vivistim Stroke Therapy; Johnson & Johnson Introduces Cereglide™ 42, Cereglide™ 57, and Innerglide™ 7 to Strengthen Catheter Portfolio; Baird Medical Advances Worldwide Registration of AI-Based Surgical Technology; THINK Surgical Achieves First Clinical Use of the TMINI Miniature Robotic System Paired With the Stryker Triathlon Knee System; Monteris Medical Reports Study Linking NeuroBlate® Laser Ablation to Stronger Immunotherapy Response in Recurrent High-Grade Brain Tumors
Abbott’s Next‑Generation Cardiomems™ Remote Heart Failure Monitoring Reader Received FDA Approval to Enhance Patient Experience and Help Detect Disease Progression On 27 February 2026, Abbott announced that the U.S. Food and Drug Administration (FDA) had approved the company’s CardioMEMS™ HERO device, a ne...
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Feb 19, 2026
Medtronic Wins FDA Green Light for Stealth AXiS; Retia Medical Secures FDA 510(k) Clearance for Argos Infinity; Danaher Announces Plan to Acquire Masimo Corporation; Dynarex Introduces New Advanced Negative Pressure Therapy Device; Valcare Medical Reports First U.S. Transseptal AMEND™ Implant in Early Feasibility Study; Envoy Medical Reports Enrollment Nearly Complete for Acclaim Cochlear Implant Pivotal Trial
Medtronic Received FDA Clearance for Stealth AXiS™ Surgical System, First Integrated Planning, Navigation and Robotics Platform for Spine Surgery On February 13, 2026, Medtronic, a global leader in healthcare technology, announced U.S. Food and Drug Administration (FDA) clearance of the Stealth AXiS™ surgical sy...
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Sep 03, 2025
AI Stethoscope: Transforming the Stethoscope Market and Cardiac Diagnostics with Unmatched Accuracy
Each year, cardiovascular diseases claim approximately 17.9 million lives globally, accounting for about one-third of all deaths, most due to heart attacks and strokes. Despite notable advancements in imaging and a growing cardiac diagnostics market, early detection of conditions like heart failure, atrial fibrilla...
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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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Feb 15, 2024
Tandem’s Automated Insulin Patch Pump; ResMed’s Bilevel Sleep Respiratory Devices; Masimo’s First Over-The-Counter Fingertip Pulse Oximeter; Viz.Ai Algorithm for Quantifying Intracerebral Hemorrhage; Canary Medical’s Heart Sound Monitor; UroMems’ Smart Urinary Sphincter System
Tandem Diabetes Care Launched Mobi Mini Automated Insulin Patch Pump On February 13, 2024, announced that it started off the U.S. commercial launch of its Mobi insulin patch pump. The San Diego-based business claims that Mobi, which is fully controllable via a smartphone app, is the world's smallest durable a...
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Oct 05, 2023
Boston Scientific’s Insertable Cardiac Monitor; Phillips-Medisize Teamed up with GlucoModicum; Boston Scientific’s Intravascular Ultrasound System; Enable Injections Received First US FDA Approval; Amber Implants’s VCFix® Spinal System; Loci Orthopaedics’s “InDx” Thumb Base Joint Replacement Study
Boston Scientific Launched Next-Generation Insertable Cardiac Monitor On October 2, 2023, Boston Scientific, announced the launch of its next-generation LUX-Dx II+ insertable cardiac monitor (ICM) system. Long-term monitoring is provided by the system for arrhythmias connected to conditions like AFib, c...
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Sep 28, 2023
Orthofix Launched the Galaxy Fixation Gemini System; Oxford Biodynamics Launched the EpiSwitch Prostate Screening Blood Test; CE Mark for the Medtronic’s New Simplera CGM; FDA 510(k) Clearance to MicroVention’s SOFIA™ EX 5F 115cm; SHL Telemedicine’s SmartHeart® Technology; Cardiosense’s Nationwide Heart Failure Study
Orthofix Launched the Galaxy Fixation Gemini System and Expanded Sterile Kit Offerings for Orthopedic Trauma Procedures On September 20, 2023, Orthofix Medical Inc., a leading global spine and orthopedics company, launched the Galaxy Fixation Gemini™ system. It is a stable external fixation system that ...
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Jun 01, 2023
THINK Surgical’s TMINI Miniature Robotic System; Cepheid’s Xpert NPM1 Mutation Test; Anika’s Hyalofast® US Pivotal Phase III Study; EMVision’s Portable Brain Scanner Trial; HeartBeam and Samsung’s Strategic Alliance Agreement; Eosolutions’s Dr. Banner Balloon Guide Catheter
TMINI Miniature Robotic System by THINK Surgical Received FDA 510(k) Clearance On May 30, 2023, THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TMINI™ Miniature Robotic System. A wireless r...
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