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. ...
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. ...
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. ...
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....
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. ...
Strategic collaboration aims to accelerate validation and commercialisation of non-invasive tests, enabling earlier, more accessible diagnosis of Alzheimer’s disease ...
Strategic relocation from Hong Kong strengthens ties to Asia’s thriving MedTech ecosystem, enhances collaboration with global partners, and supports ambitious expansion plans ...
AI-powered, patient-matched solution aims to simplify Lapidus procedures and enhance surgical outcomes...
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 ...
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...