Regulatory

Visby Medical Gains FDA De Novo Authorization for First OTC PCR Sexual Health Test

Groundbreaking Approval Expands Access to Rapid, At-Home STI Diagnostics ...

Abbott’s Volt™ PFA System Gains CE Mark for Treating Abnormal Heart Rhythms

Innovative Pulsed Field Ablation Technology Advances Cardiac Care in Europe ...

Newronika’s AlphaDBS Secures CE Mark for Adaptive Deep Brain Stimulation System

Next-generation closed-loop DBS device now approved in Europe, offering real-time, personalized neuromodulation for Parkinson’s and other neurological disorders....

Okami Medical Secures FDA 510(k) Clearance for SENDERO MAX Delivery Catheter

Expanded SENDERO portfolio now supports LOBO occluders across 1.5mm to 9.0mm vessels, offering physicians a comprehensive embolization solution for rapid and reliable vessel closure. ...

Anuncia Wins FDA Breakthrough Status for ReFlow® EVD

With its expanded ReFlow® portfolio, Anuncia targets improved ICU outcomes, reduced surgical interventions, and greater global access to CSF management—from U.S. hospitals to underserved regions in Africa....

Subtle Medical’s AI-Powered SubtleHD™ Secures CE Mark, Bringing Faster, Higher-Quality MRI Imaging to Europe

Innovative software enhances MRI scan quality, reduces scan times by up to 80%, and optimizes radiology workflows without requiring hardware upgrades. ...

Boulder iQ Executives to Share Fast-Track Strategies for MedTech Innovation at LSI USA 25

Industry leaders Jim Kasic and Larry Blankenship to present time- and cost-efficient approaches for accelerating medical device development and market entry. ...

Spinal Resources Inc. Secures Patent for Bezier Parametric Curve Spinal Rod System

Innovative Spinal Rod Technology Enhances Surgical Flexibility and Patient-Specific Customization ...

Baird Medical Gains Indonesian Regulatory Approval for Microwave Ablation Technology

Approval paves the way for broader adoption of Baird Medical’s minimally invasive treatment for tumor ablation, expanding access to advanced cancer care in Indonesia. ...

Beckman Coulter Secures FDA Clearance for DxC 500i Clinical Analyzer

The integrated clinical chemistry and immunoassay system enhances efficiency, streamlines lab workflows, and delivers accurate diagnostics in a compact design....