Medical Devices Market
Apr 10, 2025
Ventris Medical Secures Additional FDA Clearance for Backpack® Bone Graft in Intervertebral Disc Applications; Orthocell Gains FDA 510(k) Clearance for Remplir™; ICU Medical Launches New Infusion Device Category with FDA-Cleared Plum Solo™ and Plum Duo™ IV Pumps; Anaconda Biomed Kicks Off U.S. Enrollment for ATHENA Trial Testing ANA Funnel Catheter in Stroke Care; OrthoPediatrics Expands Scoliosis Portfolio with Launch of Innovative VerteGlide™ System; 3D Systems Powers World’s First On-Site Facial Implant Manufacturing at Point-of-Care
Ventris Medical Received Additional FDA Clearance for Backpack® Bone Graft in the Intervertebral Disc Space On April 08, 2025, Ventris Medical, a privately held leader in orthobiologics and tissue regeneration, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance fo...
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Apr 09, 2025
AI-Driven Diagnostics: Why are They the Next Big Thing in Healthcare?
Just a few years back, imagining a machine detecting a heart attack before symptoms surfaced or spotting a tumor more accurately than the human eye sounded like science fiction. Today, it’s just another day in AI-powered healthcare diagnostics. Artificial Intelligence is no longer a distant promise—it's a living...
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Apr 03, 2025
Abbott Secures CE Mark for Volt™ Pulsed Field Ablation System and Unveils TRILUMINATE™ Trial Data on TriClip™ for Tricuspid Valve Repair; Zimmer Biomet’s RibFix Advantage® Fixation System Earns CE Mark; Teleflex Announces Initial Clinical Data from IDE Study Evaluating Ringer™ PBC in Coronary Perforation Treatment; GE HealthCare Launches Revolution™ Vibe CT, Bringing Unlimited One-Beat Cardiac Imaging and AI Solutions; TELA Bio Launches Larger OviTex® PRS Sizes in the U.S.
Abbott Received CE Mark for Volt™ Pulsed Field Ablation System, Offering New Therapy Option for Heart Rhythm Disorders On March 27, 2025, Abbott announced that it received the CE Mark in Europe for its VoltTM Pulsed Field Ablation (PFA) System, designed to treat patients with atrial fibrillation (AFib). Th...
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Mar 27, 2025
Alcon Gains CE Mark for Clareon Vivity IOL in Europe; MicroPort MedBot’s Toumai SP Robot Wins NMPA Approval; Abbott Launches Intravascular Lithotripsy Trial; BD Advances GalaFLEX LITE™ Clinical Trial; GE HealthCare Unveils AI-Powered Invenia ABUS Premium; Okami Medical Introduces SENDERO® MAX Catheter
Alcon Announced CE Mark Approval and Launch of Clareon Vivity IOL in Europe, Expanding Visual Options On March 25, 2025, Alcon, the global leader in eye care committed to enhancing vision, announced that Vivity®, the most widely implanted extended depth of focus (EDOF) intraocular lens (IOL), became availa...
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Mar 20, 2025
Illuccix Receives Dutch Approval for PSMA-PET Imaging in Prostate Cancer; FDA Approves Valcare Medical’s Early Feasibility Study for Novel Amend™ Trans-Septal System; RevBio Launches Pivotal Clinical Trial in Europe for Dental Implant Stabilization; Insulet’s RADIANT Trial Highlights Improved Glycemic Outcomes with Omnipod® 5 Following Direct Transition; Envoy Medical Raises $10 Million to Drive Clinical Progress on Next-Gen Hearing Device; Vave Health Unveils World’s First Wireless Whole-Body Ultrasound with Single PZT Transducer
Illuccix® Prostate Cancer PSMA-PET Imaging Agent Approved in the Netherlands On March 18, 2025, Telix announced that its prostate cancer PET imaging agent, Illuccix® (kit for the preparation of gallium-68 gozetotide injection), received marketing authorization from the Medicines Evaluation Board (MEB) in t...
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Mar 13, 2025
Caristo Wins FDA Clearance for AI Solution to Prevent Heart Attacks; Lindus Health and Sooma Medical Announce Key Clinical Trial for MDD Device; GT Metabolic Secures FDA Clearance for Expanded 50mm MagDI System; Beckman Coulter’s DxC 500i Integrated Analyzer Earns FDA Clearance for Enhanced Diagnostics
Caristo Wins FDA Clearance for AI Solution to Prevent Heart Attacks Caristo Diagnostics, focused on transforming the diagnosis and treatment of cardiovascular disease, has announced that its CaRi-Plaque technology has received 510(k) clearance from the FDA. CaRi-Plaque is an AI-powered image analysis tool design...
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Mar 06, 2025
ABANZA Secures FDA 510(k) Clearance for WasherCap™ Mini; Cerus Corporation Secures CE Mark for Next-Gen INTERCEPT Illumination Device; Spinal Stabilization Technologies Enrolls First U.S. Patient in IDE Trial for PerQdisc™; Inspira Technologies Reports Positive Clinical Results for AI-Integrated HYLA Blood Sensor; iCAD and RamSoft Partner to Expand ProFound AI Mammography Solutions in North America; Pulnovo Medical Secures Nearly $100M in Series C Funding
ABANZA Received FDA 510(k) Clearance for WasherCap™ Mini Implantable Fixation Device, Advancing Soft Tissue Repair Solutions On February 26, 2025, ABANZA, a leader in advanced soft tissue repair solutions announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its innovative...
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Feb 27, 2025
Medtronic Secures FDA Approval for First-Ever Adaptive Deep Brain Stimulation System for Parkinson’s; FDA Grants Breakthrough Device Designation to Averto Medical’s ColoSeal™ System; Biomerica’s inFoods® IBS clinical trial findings were published in Gastroenterology; Lungpacer Medical’s STIMULUS Trial Highlights Improved Hemodynamics With Diaphragm Neurostimulation; Alcon Introduces Voyager DSLT; Stryker Finalizes Acquisition of Inari Medical
Medtronic Earned U.S. FDA Approval for the World's First Adaptive Deep Brain Stimulation System for People With Parkinson's On February 24, 2025, Medtronic plc, a global leader in healthcare technology, announced that it had received U.S. Food and Drug Administration (FDA) approval for BrainSense™ Adaptive...
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Feb 20, 2025
FDA Grants 510(k) Clearance to Neonav® ECG Tip Location System; ClearPoint Neuro Secures EU MDR Certification for SmartFlow Cannula; Volta Medical’s AI-Driven Ablation Procedure Improves Outcomes in Persistent Atrial Fibrillation Trial; WhiteSwell Presents New Clinical Data on eLym System for Acute Heart Failure Treatment; J&J MedTech Introduces CEREGLIDE™ 92 Catheter System; Thermo Fisher Launches New Spatial Imaging System for Tissue Proteomics
Neonav® ECG Tip Location System Received FDA 510(k) Clearance to Improve Pediatric Vascular Access Care On February 16, 2025, Navi Medical Technologies, a leader in pediatric healthcare innovation, announced that its Neonav® ECG Tip Location System received 510(k) clearance from the U.S. Food and Drug Admi...
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Feb 13, 2025
Agiliti Launches Essentia; KUBTEC Introduces PICASSO Plus; FDA Clears Neuvotion’s NeuStim™ for Non-Invasive Hand Stimulation in Stroke & SCI Patients; Ibex Medical Analytics Achieves Milestone with FDA 510(k) Clearance; BlueWind Medical Reports Strong Two-Year Outcomes for Revi® System in Peer-Reviewed Study; Reprieve Cardiovascular’s FASTR Pilot Trial Shows Positive Outcomes, FDA Approves IDE for Next Phase
Agiliti Launched Essentia, an Innovative Multi-Acuity Hospital Bed that Helps Lower Patient Risk and Accelerate Mobility On February 11, 2025, Agiliti, a prominent manufacturer and provider of medical device solutions for the U.S. healthcare industry, introduced Essentia™, a versatile multi-acuity bed fram...
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