Medical Devices Market
Sep 11, 2025
ONWARD Medical’s ARC-EX System Gains CE Mark; Microbot Medical Secures FDA 510(k) Clearance for LIBERTY® Endovascular Robotic System; Fraiya Launches Major NHS Clinical Trial Using AI for Pregnancy Ultrasounds; Medtronic Hugo™ Robotic-assisted Surgery System in Hernia Repair Met Safety and Effectiveness Endpoints; Willow Launches Willow Wave, Pioneering a New Standard in Breastfeeding; Vivalink Launches New Adhesive to Improve Wearable ECG Performance
ONWARD Medical Received CE Mark for ARC-EX, Enabling Commercial Launch of Breakthrough Spinal Cord Stimulation System in Europe On September 8, 2025, ONWARD Medical N.V., a leading neurotechnology company developing therapies to restore movement, function, and independence for individuals with spinal cord ...
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Sep 10, 2025
From Lab to Bedside: The Rise of AI-Enabled Digital Pathology
Pathology—the discipline of diagnosing disease through tissue analysis, has long depended on glass slides and microscopes. Today, digital pathology is undergoing a remarkable shift, as whole-slide imaging (WSI) and artificial intelligence (AI) come together to streamline lab workflows, accelerate diagnoses, and enh...
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Sep 04, 2025
Geneseeq Technology Inc.’s GENESEEQPRIME® Assay Receives FDA 510(k) Clearance; Medtronic’s MiniMed™ 780G Gains FDA Approval for Abbott Instinct Sensor Integration and Type 2 Diabetes Use; CorNeat Vision’s Artificial Cornea Restores 20/20 Vision for Shingles-Induced Blindness; Johnson & Johnson Reports Favorable Outcomes from Real-World VARIPULSE™ PFA Study at 2025 ESC Congress; SprintRay Strengthens Dental 3D Printing Portfolio with EnvisionTEC Acquisition; Olympus Unveils Latest Imaging Platform for ENT and Urology in the U.S.
Geneseeq Technology Inc. Received FDA 510(k) Clearance for GENESEEQPRIME® Assay On September 02, 2025, Geneseeq Technology Inc. announced that the U.S. Food and Drug Administration (FDA) had granted 510(k) clearance for its GENESEEQPRIME® NGS Tumor Profiling Assay. This in vitro diagnostic (IVD) test kit used ne...
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Sep 03, 2025
AI Stethoscope: Transforming the Stethoscope Market and Cardiac Diagnostics with Unmatched Accuracy
Each year, cardiovascular diseases claim approximately 17.9 million lives globally, accounting for about one-third of all deaths, most due to heart attacks and strokes. Despite notable advancements in imaging and a growing cardiac diagnostics market, early detection of conditions like heart failure, atrial fibrilla...
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Aug 28, 2025
Esaote’s MyLab™ A50 and A70 Ultrasound Systems Achieve FDA 510(k) Clearance; Health Canada Approves MedMira’s Reveal® TP Rapid Test for Syphilis; MolecuLight’s Transformative Effect on Wound Care Confirmed by Large Randomized Trial; Arctx Medical’s ACC Kit Receives FDA IDE Approval and Dr. Robert Kieval Appointed CEO; Quest’s Haystack MRD Test Awarded FDA Breakthrough Device Designation for Post-Surgical Colorectal Cancer Monitoring; Sonic Healthcare USA Strengthens Oncology Diagnostics with Acquisition of Cairo Diagnostics
FDA Granted Approval to Esaote’s MyLab™ A50 and MyLab™ A70 Ultrasound Systems On August 25, 2025, Esaote announced that its MyLab™ A50 and MyLab™ A70 ultrasound systems had received FDA approval, marking a significant milestone that confirmed the systems’ compliance with the highest standards of safety and clini...
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Aug 27, 2025
The Revolution of Healthcare: Smart Medical Devices Transforming the Future
The global healthcare landscape is witnessing a seismic shift, propelled by the rapid integration of smart healthcare technology into everyday medical practice. At the forefront of this transformation are smart medical devices are intelligent tools that combine advanced sensors, wireless connectivity, data analytic...
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Aug 27, 2025
10 Powerful Applications of Mobile Clinics Around the World Bridging the Healthcare Gap
In a world where access to healthcare can mean the difference between life and death, mobile clinics are revolutionizing the delivery of medical services. A fully equipped van rolling into a remote village, transforming a dusty parking lot into a bustling hub of hope and healing. These "healthcare on wheels" units ...
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Aug 21, 2025
FDA Grants 510(k) Clearance to Nerveblox AI; Labcorp Introduces the First FDA-Cleared Alzheimer’s Blood Test; Calidar Introduces First-of-its-Kind 4D Mammography System; ONWARD Medical to Initiate Empower BP Pivotal Study Following FDA IDE Approval; Tenon® Medical Launches Catamaran® SE SI Joint Fusion System Nationwide; Rivanna Secures $800,000 Virginia Catalyst Grant Plus Matching Funds to Advance AI-Driven Ultrasound Innovation
Nerveblox, the Ultrasound AI for Regional Anesthesia Received FDA Clearance On August 18, 2025, Nerveblox, an AI-powered software developed by SmartAlpha to assist physicians in performing ultrasound-guided regional anesthesia, received U.S. Food and Drug Administration (FDA) 510(k) clearance. This milesto...
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Aug 20, 2025
Top 5 Surgical Simulation Companies Revolutionizing Surgical Education
Surgical simulation has emerged as one of the most transformative shifts in medical education and practice. With patient safety at the forefront and growing pressure to reduce medical errors, simulation technologies offer a safe, controlled, and repeatable way to train. Unlike traditional cadaver labs or observatio...
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Aug 14, 2025
Nyxoah Secures FDA Nod for Genio® System in OSA Treatment; FDA Grants First 510(k) Clearance to DeepSight™-Powered NeedleVue™ LC1 Ultrasound System; TITAN CSR® Retractor Tops U.S. Military List for Trauma Care in Deployed Settings; FDA Clears Myra Vision to Begin US IDE Study for Glaucoma; HistoIndex Advances Fibrosis Assessment with AI-Powered FibroSIGHT™ Plus; Gentuity Partners with GE HealthCare to Broaden Access to Cutting-Edge Intravascular Imaging
FDA Approves Nyxoah’s Genio® System for Treating Obstructive Sleep Apnea On August 08, 2025, Nyxoah SA, a medical technology company that developed breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, announced that the U.S. Food and Drug Administration (FDA) had a...
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