MedTech Spectrum

Article Name Medical Devices

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

Philips Partners with Epic to Advance Ambulatory Cardiac Monitoring Integration

Collaboration aims to streamline cardiac data workflows and enhance clinical decision-making through seamless EHR integration.

28th July, 2025

GE HealthCare Launches Advanced Digital X-Ray System for High-Volume Imaging Environments

New solution aims to enhance workflow efficiency, image quality, and accessibility in busy hospitals and diagnostic centers worldwide.

28th July, 2025

Seegene Debuts World’s First Fully Unattended PCR Automation at ADLM 2025

Breakthrough system set to revolutionize molecular diagnostics by enabling 24/7 sample-to-result PCR testing with no human intervention.

25th July, 2025

Scopio Labs Launches World’s First Fully Automated AI Blood Morphology System

Breakthrough technology aims to transform hematology diagnostics by combining full-field imaging and AI-driven analysis for faster, more accurate results.

25th July, 2025