MedTech Market
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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Jan 09, 2025
Roche Secures FDA Clearance for High-Volume Slide Scanner; Pacira Gets 510(k) Approval for Iovera° SmartTip for Chronic Back Pain; ClearCut Presents Clearcoast™ Study Results at San Antonio Breast Cancer Symposium; NanoVibronix Completes UroShield® Pilot Study at University of Michigan; Hologic Finalizes Acquisition of Gynesonics; Movano Health Launches EvieAI Virtual Wellness Assistant.
Roche's Momentum in Digital Pathology Continued With FDA Clearance on its High-Volume Slide Scanner On January 09, 2025, Roche announced that its whole slide imaging system, Roche Digital Pathology Dx, received an additional 510(k) clearance from the United States Food and Drug Administration (FDA). This c...
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Jan 02, 2025
Genesis Medtech Secures Chinese Approval for Innovative 90° Articulating Stapler; Inogen Secures FDA 510(k) Clearance for SIMEOX 200 Airway Clearance Device; Microtech Unveils First Human Trial of Implantable Microsensor for Heart Failure Monitoring; NAVIGANTIS VASCO™ Platform Begins Clinical Role in Neurovascular Patient Study; Innovent Secures Global Rights from Roche for Novel DLL3 ADC in Exclusive Deal; Treace Expands Portfolio with Percuplasty
Genesis Medtech's World's First 90° Articulation Powered Stapler Achieved Chinese Approval On January 01, 2025, Genesis Medtech announced that iReach Omnia, the world's first powered stapler with 90° articulation capability, received market approval in China from the National Medical Products Administratio...
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Dec 26, 2024
FDA Grants Approval to Merit Medical’s WRAPSODY Endoprosthesis; FDA Clears AVITA Medical’s Cohealyx, Expanding Treatment Potential; SeaStar Medical Launches 14th Location for Adult AKI Pivotal Study; Contego Medical’s Neuroguard IEP System Treats First Patients; SMT Introduces Hydra™ TAVI System in Russia; SandboxAQ Raises $300M+ to Accelerate AI’s Next Frontier
Merit Medical Announced FDA Approval of the WRAPSODY Cell-Impermeable Endoprosthesis On December 20, 2024, Merit Medical Systems, Inc., a leading global manufacturer and marketer of advanced healthcare technologies, announced that its WRAPSODY® Cell-Impermeable Endoprosthesis received premarket approval (P...
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Dec 19, 2024
Siemens Healthineers Acquires Molecular Imaging Division from Novartis; BD and Babson Diagnostics Unveil Fingertip Blood Testing for Health Care; Medtronic Completes First Ingestion of Pillcam™ Genius SB Kit; FDA Expands Impella Heart Pump Use to Pediatric Patients; Zimmer Biomet Receives FDA Nod for OsseoFit™ Stemless System; enVVeno Medical Completes Final Implants in Pre-Clinical GLP Study
Siemens Healthineers Acquired Novartis’s Advanced Accelerator Applications Molecular Imaging On December 10, 2024, Siemens Healthineers completed the acquisition of Advanced Accelerator Applications Molecular Imaging from Novartis. This European manufacturing and distribution network specializes in diagnos...
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