Article Name Medical Devices
Concept Medical Launches Major U.S. Trial for Sirolimus-Coated Balloon in Small Vessels
Concept Medical Announces First Patient Enrollment in MAGICAL-SV IDE Trial, Expanding its Coronary Clinical Program Across the U.S. and Europe
05th August, 2025
Roche’s cobas® Respiratory 4-flex wins FDA nod for customisable, multi-virus PCR testing.
Designed for use with cobas® 5800, 6800, and 8800 systems, the cobas Respiratory 4-flex assay simultaneously detects and differentiates SARS-CoV-2, influenza A/B, and RSV, leveraging TAGS technology and digital reflex capabilities to enhance diagnostic precision and efficiency.
05th August, 2025
Sony Expands Surgical Display Portfolio with Launch of 43” 4K Mini LED Monitor for Advanced Operating Environments
The new LMD-43M1MD delivers immersive, high-resolution visualisation with wide-angle team visibility and multi-source flexibility, designed to meet the evolving demands of hybrid ORs, complex procedures, and surgical training.
04th August, 2025
ELIXIR MD Expands into Australia and New Zealand with Exclusive Launch of Breakthrough Facial Surgery Device
In partnership with High Tech Medical Pty Ltd., ELIXIR MD brings its proprietary ELIXIR MD™ device and advanced perioperative protocols to one of the world’s fastest-growing aesthetic surgery markets, redefining post-operative care and patient recovery outcomes.
04th August, 2025
MiRus Secures NTAP Approval from CMS for Breakthrough EUROPA® Cervical Spine System
Awarded for its proprietary MoRe® alloy-based 2.9 mm rod, the EUROPA® PCF System offers a low-profile, high-strength solution for cervical and upper thoracic spine surgery—now eligible for Medicare reimbursement under the New Technology Add-on Payment programme.
04th August, 2025
Galaxy Therapeutics Opens New 9,200 Sq. Ft. Facility to Support Global Scale-Up of Brain Aneurysm Solutions
Equipped with ISO Class 7 cleanrooms and expanded R&D capacity, the new site accelerates Galaxy’s path to commercial readiness and global distribution of its breakthrough neurovascular technologies.
31st July, 2025
ClariMed Achieves ISO 13485:2016 Certification, Strengthening Global Medical Device Development Capabilities
Milestone underscores ClariMed’s commitment to quality excellence and reinforces its position as a trusted partner in navigating complex global regulatory landscapes
30th July, 2025
Quasar Medical Establishes Global Headquarters in Singapore to Drive MedTech Innovation and Global Growth
Strategic relocation from Hong Kong strengthens ties to Asia’s thriving MedTech ecosystem, enhances collaboration with global partners, and supports ambitious expansion plans
30th July, 2025
Johnson & Johnson MedTech Launches VIRTUGUIDE™ System to Transform Bunion Surgery with AI Precision
AI-powered, patient-matched solution aims to simplify Lapidus procedures and enhance surgical outcomes
30th July, 2025
How the FDA’s 510(k) Pathway and Risk-Based Oversight Are Shaping the Future of Medical Device Regulation
By aligning regulatory rigour with technological complexity, the FDA safeguards public health while accelerating access to life-changing medical innovations through adaptive pathways and total lifecycle vigilance
30th July, 2025
Surgical Safety Technologies Introduces AI-Powered Kinematic Analysis in OR Black Box
First camera-agnostic motion tracking solution for laparoscopic surgery delivers real-time insight into surgical technique and proficiency across all devices and operating rooms
30th July, 2025
Stryker’s Inari Division Debuts InThrill Thrombectomy System
First and only purpose-built solution delivering rapid and complete luminal clot removal in small vessel and arteriovenous access cases
30th July, 2025
Siemens Healthineers Leads the Way in Laboratory Sustainability with ACT Ecolabel Certification for Over 150 Diagnostic Reagents
First in the industry to achieve dual certification for both reagents and analysers within its Atellica portfolio
30th July, 2025
Aptitude Medical Secures $9M BARDA Partnership to Advance Rapid Filovirus Diagnostic for Ebola and Marburg Detection
New Metrix Filovirus Panel to deliver 30-minute, lab-quality results from blood samples in remote and point-of-care settings—marking a pivotal step in global outbreak preparedness.
29th July, 2025
Stereotaxis Secures FDA Clearance for MAGiC Sweep Catheter
New magnetic ablation catheter designed to enhance precision and reach in robotic electrophysiology procedures across the U.S.
28th July, 2025
Embolx Unveils Sniper G3: Next-Generation Pressure-Directed Microcatheter for Embolization
Designed for greater control, streamlined usability, and longer shelf life, Sniper G3 sets a new benchmark in targeted vascular intervention.
28th July, 2025
Quanterix Unveils Next-Generation p-Tau 205 and p-Tau 212 Assays to Propel Alzheimer’s Research
Launched at AAIC 2025, the ultra-sensitive assays aim to improve early detection, disease monitoring, and biomarker discovery in neurodegenerative research.
28th July, 2025
Matrix Medical Network Partners with Molecular Testing Labs to Expand In-Home Diagnostic Capabilities
Collaboration aims to improve access to advanced lab testing through at-home services, supporting earlier detection and personalized care delivery.
28th July, 2025
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