Regulatory

42 Olympus Medical Devices Face FDA Import Alert Over Quality Violations

Following multiple unresolved warnings, the U.S. FDA enforces import restrictions on 42 Olympus endoscopic devices, spotlighting persistent quality system lapses at its Aizu facility in Japan and triggering global scrutiny of manufacturing and patient safety standards. ...

ANACONDA Biomed Earns CE Mark for ANA5 Funnel Catheter

Next-Gen Stroke Device Aims to Enhance Clot Removal and Improve Outcomes in Ischemic Stroke Treatment Across Europe...

Medtech Industry Prioritizes Postmarket Quality Overhaul

88% of Companies Set Modernization Plans in Motion Within Three Years ...

JBA AI Secures FDA Recognition for Software as a Medical Device (SaMD)

Regulatory Milestone Validates JBA AI’s Clinical-Grade Software for Advanced Diagnostic Support...

ZYLOX Wins Indonesian Approval for Unicorn™ Vascular Closure Device

Regulatory clearance marks strategic expansion of ZYLOX’s innovative vascular technology in Southeast Asia....

Koning Health Partners with Sage Tap Poder to Advance Global Adoption of Koning Breast CT

New investment to accelerate global rollout of Koning’s 3D breast imaging technology....

Median Technologies Unveils eyonis® LCS at Major North American Health Conferences

Groundbreaking Imaging Technology for Cancer Detection to Be Presented in May 2025...

VUNO’s AI Cardiac Risk System Gains CE MDR and UKCA Certifications

Milestone Approvals Enable European and UK Market Access for AI-Based Cardiac Arrest Prediction Tool...

Teal Health’s Teal Wand™ Receives FDA Approval as First At-Home Cervical Cancer Screening Device

Breakthrough self-collection technology offers women a more comfortable, accessible alternative to traditional in-clinic screenings, aiming to boost early detection and public health outcomes. ...

InMode Secures Injunction to Halt Counterfeit Morpheus8 Sales

Court Blocks Unauthorized Distribution of InMode’s RF Microneedling Devices and Cartridges in Major IP Protection Win ...