MedTech Market
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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Feb 06, 2025
Bioretec Ltd. Gains CE Mark for RemeOs™ Trauma Screw; HoneyNaps’ AI Sleep Diagnostic Software Achieves Recognition as the 73rd and 74th Innovative Medical Devices by South Korea’s MFDS; Movano Health Advances Clinical Trials for Innovative Non-Cuff Blood Pressure Monitor; IRB Approves PathMaker Neurosystems’ MyoRegulator® ALS Study; Aspen Medical Products Closes Deal to Acquire Advanced Orthopaedics; Surmodics Achieves Early Clinical Success with Pounce™ XL Thrombectomy System
Bioretec Ltd. Secured CE Mark Approval for RemeOs™ Trauma Screw, Enabling European Market Launch On January 31, 2025, Bioretec Ltd., a leader in absorbable orthopedic implants, successfully completed the CE mark approval process and began the commercialization of its RemeOs™ Trauma Screw product portfolio ...
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Jan 30, 2025
Norlase’s LYNX Receives FDA and CE Approval for Clinical Use; FDA Approves Imperative Care’s Zoom System; Lunit AI Enhances Predictive Accuracy for HER2-Targeted Therapy in Metastatic Colorectal Cancer; ImmunoMet Reports New Insights from Phase 1b Study of Lixumistat in Pancreatic Cancer; Lumicell Announces U.S. Launch of LumiSystem; Inventia Life Science Introduces RASTRUM™ Allegro to Advance High-Throughput 3D Cell Culture
Norlase Received FDA 510(k) Clearance and CE Mark for LYNX™ Indirect Laser Ophthalmoscope with Pattern Tracking On January 27, 2025, Norlase, a leading global manufacturer of ophthalmic lasers developing next-generation laser solutions, announced the commercial launch and receipt of FDA 510(k) clearance and CE M...
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Jan 23, 2025
Tempus Launches FDA-Approved xT CDx Test Nationwide; B. Braun Enhances Catheter Securement with the Launch of Clik-FIX; Illuccix® Secures European Regulatory Approval; FDA Clears CapsoCam Plus® for Remote Ingestion; BellaSeno Marks Success in Two Clinical Trials for Revolutionary Breast Implant Technology; AF Symposium to Feature Conformal Medical’s Groundbreaking GLACE Study
Tempus Announced the National Launch of the FDA-Approved xT CDx Test On January 15, 2025, Tempus AI, Inc., a technology company driving the use of AI to advance precision medicine and improve patient care, announced the nationwide launch of its FDA-approved, NGS-based in vitro diagnostic device, xT CDx. Th...
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Jan 16, 2025
Johnson & Johnson MedTech Secures CE Mark for Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter; Medtronic Secures CE Mark for BrainSense™ Adaptive Deep Brain Stimulation; Inquis Medical Finalizes Enrollment for U.S. Pivotal Study on Aventus Thrombectomy System for Pulmonary Embolism; First Patient Enrolled in Argon Medical’s CLEAN-PE Study for Novel Pulmonary Embolism Therapy; Sutter Health and GE HealthCare Partner to Revolutionize Patient Care with AI-Driven Imaging Solution; Saluda Medical Closes $100M Financing to Expand Neuromodulation Portfolio
Johnson & Johnson MedTech Announced CE Mark Approval for Dual Energy THERMOCOOL SMARTTOUCHTM SF Catheter, Bolstering Capabilities in Cardiac Arrhythmias Treatment On January 10, 2025, Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, announced the receipt of European CE ma...
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