Regulatory

The 2025 Index: 100 FDA-Approved AI-Driven Medical Devices

Spanning Radiology, Cardiology, Neurology, and More, the List Highlights FDA’s Ongoing Commitment to Advancing Safe and Effective AI Integration in Healthcare...

SimBioSys Earns Third FDA Clearance for TumorSight™ Viz

AI-Powered 3D Surgical Planning Tool Advances Precision Breast Cancer Surgery with Latest Regulatory Milestone...

U.S. FDA Grants Breakthrough Device Designation to Artera’s AI-Powered Prostate Cancer Decision Support Tool

Innovative software platform leverages artificial intelligence to personalize therapy decisions and improve clinical outcomes for prostate cancer patients....

MediView Launches Multicenter Study to Validate XR90™ Extended Reality Surgical Navigation

Study to Evaluate Accuracy and Clinical Impact of XR-Guided Soft Tissue Biopsy Across Leading U.S. Medical Centers...

Boston Scientific Secures FDA Approval for Expanded Labeling of FARAPULSE™ PFA System

Milestone enhances clinical use of the FARAPULSE™ Pulsed Field Ablation platform for treatment of atrial fibrillation, strengthening its role in next-generation cardiac electrophysiology....

Morphic Medical Secures CE Mark for RESET® Endoscopic Therapy Device

Regulatory milestone paves the way for expanded access to Morphic’s non-implant, incisionless solution for treating acid reflux and related gastrointestinal disorders across Europe....

ReCerf Receives CE Mark, Expanding Access to Advanced Hip Resurfacing in Europe

Ceramic-based hip resurfacing implant gains European regulatory approval, offering patients a bone-preserving, metal-free alternative for hip joint restoration....

BCC Research Publishes 2024 Review of Global Medical Devices Market

Comprehensive Report Highlights Emerging Trends, Market Drivers, and Forecasts Shaping the Future of the Medical Devices Industry....

Philips Secures FDA Clearance for SmartSpeed Precise, Advancing MRI Speed and Image Precision

Dual AI-Powered Imaging Software Set to Enhance Diagnostic Confidence and Workflow Efficiency in MRI...

Median Technologies Advances AI-Powered Lung Cancer Screening with CE Mark Filing for eyonis® LCS

Regulatory submission for Class IIb CE Mark and ISO 13485 certification paves the way for European launch of Median’s AI-driven SaMD platform targeting early lung cancer detection....