medical device
Apr 30, 2025
Navigating U.S. Tariffs in 2025: Impacts and Strategies for Pharma and Healthcare
In 2025, the United States launched a bold new wave of tariffs, targeting imports critical to the pharmaceutical and healthcare industries. These policies, driven by a push to strengthen domestic manufacturing, impose a 10% tariff on all imported goods, alongside steeper levies of up to 245% on Chinese active pharm...
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Apr 24, 2025
FDA Approves Simplera Sync™ Sensor for MiniMed™ 780G System; BVI Medical Secures FDA 510(k) Clearance for Leos™ Laser Endoscopy System in Ophthalmology; Surmodics Announces TRANSCEND Trial Data Supporting SurVeil™ Drug-Delivery Platform; Elutia Launches EluPro™ Registry Study to Gather Real-World Clinical Data; BD Launches Next-Generation AI-Driven Hemodynamic Monitoring and Industry-First Bioabsorbable Mesh for Umbilical Hernia Repair
New Simplera Sync™ Sensor for the MiniMed™ 780G System Secured FDA Approval, Advancing Insulin Delivery On April 18, 2025, Medtronic plc, a global leader in healthcare technology, received FDA approval for its Simplera Sync™ sensor for integration with the MiniMed™ 780G system. This approval enhances the f...
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Apr 23, 2025
Exploring the Impact of AI in Mental Health: How it is Going to Revolutionize Diagnosis and Treatment for a Better Tomorrow?
One in every eight people worldwide lives with a psychiatric disorder—a staggering statistic that underscores the deep and growing impact of mental illness on global health. The mental health crisis has evolved into a pressing public health emergency, fueled by increasing social pressures, lifestyle changes, enviro...
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Apr 17, 2025
Edwards’ SAPIEN M3 Becomes First Transfemoral TMVR System to Receive CE Mark; Terumo Neuro Receives FDA Clearance for Carotid Stent System; Microbot Medical Reports Complete Robotic Navigation Success in LIBERTY® System Pivotal Trial; J&J MedTech Marks Milestone with First OTTAVA™ Robotic Surgeries; Baxter Introduces Room-Temperature Hemopatch for Faster Surgical Hemostasis; Merit Medical Introduces the Ventrax™ Delivery System
Edwards' SAPIEN M3 Received CE Mark as the World’s First Transfemoral TMVR System On April 14, 2025, Edwards Lifesciences Corporation announced that its SAPIEN M3 mitral valve replacement system had received CE Mark for the transcatheter treatment of patients with symptomatic (moderate-to-severe or severe)...
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Apr 16, 2025
Non-Surgical Body Contouring: What’s Fueling Its Growth in Aesthetic Medicine?
In the ever-evolving world of aesthetic medicine, non-surgical body contouring has emerged as a beacon of innovation, offering patients a path to their ideal physique without the scalpel. Imagine a treatment that melts away stubborn fat, tightens skin, and even tones muscle—all while you relax, with no downtime to ...
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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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