Regulatory

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 ...

Turbett Surgical Secures FDA 510(k) Clearance for Enhanced Instrument Pod Portfolio

New TS1200 model supports up to 300 lbs, offering hospitals a more efficient, scalable solution for surgical instrument transport and storage....

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. ...