Wednesday, 24 September 2025

Regulatory

Medtronic Responds to CMS Proposed National Coverage Determination for Symplicity Spyral™ RDN System

Company Welcomes Milestone Toward Expanding Medicare Access to Innovative Renal Denervation Therapy for Uncontrolled Hypertension...

AirLife and Vyaire Recall Infant Ventilation Circuits Over Life-Threatening Disconnection Risk

FDA issues Class I recall for AirLife Infant Heated Wire Circuits following reports of adapter disconnections that could lead to hypoxia or respiratory failure in neonatal patients. ...

FDA Lists 200+ Sensor-Based Digital Health Devices Cleared Between 2014–2025, Redefining Remote Patient Monitoring

From smartwatches to continuous glucose monitors, the growing FDA list highlights how wearable sDHTs are transforming healthcare beyond the clinic into homes and everyday life...

FDA Lists 90+ AR/VR Medical Devices Approved Between 2015–2025, Cementing a Decade of Immersive Tech in Clinical Care

With dozens of approved devices across neurology, orthopaedics, and radiology, the FDA underscores its commitment to guiding safe, innovative integration of augmented and virtual reality in healthcare...

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....