Global/International

Medtronic Secures FDA Approval for BrainSense™ Adaptive DBS, Pioneering Largest BCI-Enabled Therapy Launch

New real-time, self-adjusting deep brain stimulation system transforms Parkinson’s care with personalized neuromodulation...

Immunovia to Appoint New CFO as Company Shifts Focus to U.S. Market

With plans to commercialize its pancreatic cancer test in the U.S. by late 2025, Immunovia seeks financial leadership with diagnostics expertise and global capital market experience....

Co-Diagnostics Withdraws 510(k) Submission for COVID-19 Test to Pursue Enhanced Version

Following constructive discussions with the FDA, Co-Dx shifts focus to an improved test submission, incorporating platform advancements and optimizing long-term performance....

UroMems Achieves Major Milestone in First-Ever Smart Implant Study for Female SUI Patientsv

With all female patients in its groundbreaking clinical feasibility study reaching six-month primary endpoints, UroMems' UroActive System marks a transformative step in treating stress urinary incontinence. The AI-powered smart implant, designed to enhance patient quality of life, is now paving the way for expanded adoption in the U.S. and Europe. ...

CathVision Secures CE Mark for ECGenius System, Expanding Electrophysiology Innovation Across Europe

With CE Mark certification, the AI-powered ECGenius System is now approved for commercialization in the European Economic Area, enhancing real-time electrogram recording and clinical decision-making for healthcare providers....

AESOP Technology Unveils AI-Driven Model to Combat Wrong-Site Surgery and Enhance Patient Safety

Leveraging machine learning, the Association Outlier Pattern (AOP) model provides real-time decision support and retrospective analysis, addressing surgical errors and strengthening healthcare reporting systems....

B. Braun Launches Emergency Department Single-Shot Nerve Block Tray to Enhance Acute Pain Management

Designed for emergency settings, the new tray features the Ultraplex® 360 Needle with advanced echogenic technology, enabling precise regional anesthesia as a safer alternative to opioids. ...

QuantalX Secures CE MDR Approval for Delphi-MD, Paving the Way for EU Commercialization

Breakthrough Neurodiagnostic Device Aims to Transform Early Detection and Treatment of Neurological Disorders Across Europe...

Intelligent Bio Solutions expands global reach with Drug Screening System upgrade

The enhanced system now supports multiple languages, improving accessibility for global drug screening operations....

UCSF and GE HealthCare Launch Care Innovation Hub to Tackle Cancer and Neurodegenerative Diseases with Advanced Imaging Solutions

New joint research initiative combines UCSF’s clinical and research expertise with GE HealthCare’s engineering innovation to improve diagnosis, enhance access to precision treatments, and drive breakthroughs in brain health, oncology, and imaging technology....