Medical Devices Market
Oct 08, 2026
Okami Medical Secures Expanded Indication for LOBO Vascular Occluder; CraniUS Therapeutics Secures Second FDA 510(k) Clearance in Six Weeks and U.S. Patent for NeuroPASS™ 3; Danaher Accelerates Life Sciences Research with New AI-Powered Autonomous Lab; Aesthetic Brokers Advises SDBotox on Strategic Partnership; BD Advances Peripheral Vascular Innovation with Positive AGILITY Trial Results; Sonorous Neurovascular Secures FDA IDE Approval for Pivotal U.S. Trial of Venous Sinus Stent in Pulsatile Tinnitus
Okami Medical Received Expanded Indication for the LOBO Vascular Occluder On 07 October 2026, Okami Medical received an expanded FDA indication for its LOBO Vascular Occlusion System, extending the device's application from peripheral arterial procedures to peripheral venous embolization. The expanded indication...
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Oct 01, 2026
UTR Therapeutics’ UTRxMYCN M1-14 Granted FDA Orphan Drug and Rare Pediatric Disease Designations; Medtronic Announces Regulatory Milestones for New Cardiac Mapping and Ablation Software; Abbott Adds SimpleScreen™ CRC Blood Test to Colorectal Cancer Screening Portfolio; VEMERIX Introduces Patented Single-Use Ultrasound Puncture Kit With Customized Probe Compatibility; Avisi Technologies to Showcase Two-Year VisiPlate® Results at AAO Annual Meeting; FIRE1 Implants First Patient in NORM-HF Pivotal Trial for Innovative Heart Failure Management
UTR Therapeutics Inc. Announced U.S. FDA Orphan Drug Designation and Rare Pediatric Disease Designation for UTRxMYCN M1-14 On 29 September 2026, UTR Therapeutics Inc. announced that the U.S. FDA had granted Orphan Drug Designation to UTRxMYCN M1-14 for the treatment of soft tissue sarcoma, including rhabdomyosar...
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Sep 24, 2026
Powerful Medical’s AI ECG Technology Earns FDA De Novo Authorization for Heart Attack Detection; Werfen Secures US FDA 510(k) Clearance and CE Mark for Aptiva® APS IgA Reagent; Ontario Introduces Fetal Blood Type Screening to Improve Pregnancy Care; Medvue Concorde Acquires Next-Generation AI-Powered MRI System; Cardiol Therapeutics Hits Phase III MAVERIC Enrollment Target Early and Expands Pivotal Trial for CardiolRx; Ferronova Reports Preliminary MAGMAP Results in 62-Patient Gastric and Oesophageal Cancer Trial
Powerful Medical Receives FDA De Novo Authorization for AI-Based ECG Model for Acute Heart Attack Detection On 15 September 2026, Powerful Medical announced that the U.S. Food and Drug Administration had granted De Novo authorization for its Queen of Hearts ACS AI ECG Model. The AI-powered technology was d...
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Sep 17, 2026
Ferronova Announces Preliminary MAGMAP Results in 62-Patient Gastric and Oesophageal Cancer Trial; Powerful Medical Secures FDA De Novo Authorization for AI ECG Model; ZEISS Advances Cataract Surgery with Introduction of AT LUCIA toric 721P; Waters Launches BD FACSDiscover A7 Cell Analyzer for Standardized Spectral Flow Cytometry; Nicklaus Children’s Hospital Completes One of the Country’s First Transcatheter Fontan Procedures in a Two-Year-Old
Ferronova Announced Preliminary Results of MAGMAP, a 62-Patient Gastric and Oesophageal Cancer Trial Investigating Lymph Node Mapping On 09 September 2026, Emboline announced that it had received U.S. FDA 510(k) clearance for its Emboliner Embolic Protection System, supporting the company's advancement in the em...
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Sep 10, 2026
Emboline Secures FDA 510(k) Clearance for Emboliner® Embolic Protection System; Alcon’s Clareon Monofocal IOL Secures EU MDR Certification from TÜV SÜD; Shoulder Innovations Enters Exclusive Partnership with ALM Ortho for Complex Shoulder Reconstruction Solutions; Avo Expands MEDITECH Alliance, Bringing Full Suite of AI Solutions to EHR; Nicklaus Children’s Hospital Performs Pioneering Transcatheter Fontan Completion in Two-Year-Old Child; AEYE Health Publishes AEYE-DS Clinical Trial Results Demonstrating High Diagnostic Accuracy and >99% Imageability
Emboline Received U.S. FDA 510(k) Clearance for Emboliner® Embolic Protection System On 09 September 2026, Emboline announced that it had received U.S. FDA 510(k) clearance for its Emboliner Embolic Protection System, supporting the company's advancement in the embolic protection device market. The system ...
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Sep 03, 2026
Spineart’s PERLA® TL Application Receives FDA 510(k) Clearance for eCential Robotics’ Op.n® Platform; Alcon’s Clareon Monofocal IOL Earns EU MDR Certification; BTL Expands Into Laser Technology With New Division and EXOLASE ONE; Stryker, IAGE Collaborate to Enhance Fluorescence-Guided Surgery Training in India; Galmed Announces Positive First-in-Human Results for Colospan’s Novel Tissue Assessment Platform; FastWave Medical Secures FDA IDE Approval for Pivotal Artero Peripheral IVL Trial
Spineart and eCential Robotics received FDA 510(k) Clearance for the PERLA® TL Application for Use with the eCential® Op.n® Navigation System for Robotic Procedures On 26 August 2026, Spineart and eCential Robotics received FDA 510(k) clearance for the PERLA TL application for use with eCential Robotics’ Op.n Na...
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Aug 27, 2026
Spineart and eCential Robotics Gain FDA Clearance for PERLA® TL Robotic Surgery Application; ZEISS CLINIC 360 Earns FDA 510(k) Clearance, Strengthening Data-Driven Patient Care; Bittium Introduces Faros Pro™ and EasyFlex™ for Extended Ambulatory ECG Monitoring; Cytrellis Expands ellacor® Micro-Coring® Technology to Australia for Full-Body Skin Resurfacing; Galmed Announces Successful First-in-Human Study of Colospan’s Novel Tissue Assessment Technology; FastWave Medical Secures FDA IDE Approval for Pivotal Artero™ Peripheral IVL Trial
Spineart and eCential Robotics Received FDA 510(k) Clearance for the PERLA® TL Application for Use with eCential® Op.n® Navigation System for Robotic Procedures On 26 August 2026, Spineart and eCential Robotics received FDA 510(k) clearance for the PERLA TL application for use with eCential Robotics’ Op.n ...
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Aug 26, 2026
How is the Active Implantable Medical Devices Market Evolving?
Active implantable medical devices (AIMDs) represent one of the most transformative categories of modern medical technology, combining electronics, materials science, and clinical medicine to deliver therapy or monitoring from within the human body itself. Unlike passive implants such as joint prostheses or vascula...
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Aug 20, 2026
Empatica Secures FDA Clearance for Parkinson’s Monitoring; ZEISS CLINIC 360 Secures FDA 510(k) Clearance; BioLab Holdings Strengthens Tissue Restoration Portfolio With Addition of FastSkin® Technology; Surity™ Expands Urinary Incontinence Care Portfolio with New At-Home Urinary Management System; Galmed Announces Positive First-in-Human Proof-of-Concept Results for Colospan’s Intraoperative Tissue Assessment Platform; FastWave Medical Secures FDA IDE Approval for Pivotal Artero™ Peripheral IVL Trial
Empatica Received FDA Clearance for Parkinson's Monitoring On 19 August 2026, Empatica announced that its Health Monitoring Platform for Parkinson’s disease had received 510(k) clearance from the U.S. Food and Drug Administration. The clearance expanded Empatica’s clinical-grade monitoring capabilities int...
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Aug 13, 2026
Leica Biosystems Expands Digital Pathology Portfolio with Multiple FDA Clearances; Bracco’s VueJect Ultrasound Contrast Delivery System Gains FDA and Health Canada Authorizations; Oticon Introduces Next-Generation Reveal Hearing Aid With AI; Zepto Life Technology Secures Up to $8.9 Million NIAID Award for Infectious Disease Liquid Biopsy Platform; Nitinotes Broadens EASE IDE Trial Network for EndoZip; FastWave Medical Secures FDA IDE Approval for Pivotal Artero Peripheral IVL Trial
Leica Biosystems Expanded Digital Pathology Portfolio with Multiple FDA Clearances On 11 August 2026, Leica Biosystems announced that it had received multiple U.S. FDA 510(k) clearances for its connected clinical digital pathology portfolio. The regulatory clearances strengthened the company's digital path...
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