Medtech

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. ...

MAGENTIQ EYE Secures Series A Funding to Accelerate Global Expansion of AI-Powered Colonoscopy Platform

Led by aMoon, the round fuels development of advanced GI diagnostics and supports global rollout of MAGENTIQ-COLO™, the FDA- and CE-cleared solution enhancing real-time polyp detection and analysis during colonoscopy procedures. ...

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. ...

Alafair Biosciences Earns Dual FDA 510(k) Clearances for VersaCoat™ Flowable Hydrogel

VersaCoat, a syringe-deliverable soft-tissue protector, brings Alafair’s proven hyaluronic acid and alginate formula to complex surgical sites—expanding its impact in orthopedic, trauma, and sports medicine procedures....

RIVANNA Secures $9.92M BARDA Funding to Fast-Track AI-Powered Fracture Detection System

With total federal support exceeding $52M, RIVANNA accelerates development of CADe/x — an AI-driven diagnostic tool poised to transform musculoskeletal care through automated ultrasound image analysis and real-time fracture triage. ...

TrilliumBiO and T-NeuroDx Partner to Advance Blood-Based Diagnostics for Early Alzheimer’s Detection

Strategic collaboration aims to accelerate validation and commercialisation of non-invasive tests, enabling earlier, more accessible diagnosis of Alzheimer’s disease ...

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 ...

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...

MD Anderson and TOPPAN Forge Alliance to Advance invivoid™ 3D Organoid Technology for Personalized Cancer Therapy

Partnership aims for CAP/CLIA certification of organoid-based assay to guide patient-specific treatment decisions; $10 million investment to fuel clinical validation across multiple cancer types ...

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...