Regulatory

ZEISS CLARUS 700 Gains Regulatory Nod in China, Expanding Ophthalmic Portfolio

The NMPA approval of the ZEISS CLARUS 700 represents a major leap forward in ultra-widefield retinal imaging, offering high-resolution, true color visualization to support early detection and management of complex eye diseases across China....

Fulgent Genetics Secures EU CE Mark for FulgentExome and FulgentPLM

Certification Advances Global Access to Comprehensive Genetic Testing and Precision Medicine Solutions in Europe...

UroMems Secures FDA and ANSM Clearance to Begin Pivotal Study of UroActive® Smart Implant for Male SUI

Landmark trial to evaluate world’s first autonomous, electronic artificial urinary sphincter for stress urinary incontinence in men...

Medtronic Secures CE Mark for LigaSure™ Integration on Hugo™ Robotic System, Advancing the Future of Surgery

The regulatory milestone enables the use of Medtronic’s trusted vessel sealing technology on its Hugo™ robotic-assisted surgery platform, enhancing precision and expanding clinical versatility across Europe. ...

HistoSonics Secures Expanded Insurance Coverage for Liver Tumor Therapy

Non-Invasive Histotripsy Treatment Now Accessible to 7 Million Blue Cross Blue Shield Highmark Members Across U.S....

Zimmer Biomet to Acquire Monogram Technologies in Strategic Move to Enhance Robotic Surgery Portfolio

Definitive agreement strengthens Zimmer Biomet’s position in orthopedic innovation by integrating autonomous robotic technology into its surgical solutions suite....

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...