Wednesday, 24 September 2025

Regulatory

Medtronic Earns CE Mark for Expanded Use of MiniMed™ 780G Insulin Pump System

Approval now includes children as young as two, pregnant individuals, and people with type 2 diabetes across Europe...

Spirair Secures FDA Clearance for TurbAlign™ Bioabsorbable Nasal Implant

Innovative device designed to maintain sinus patency post-surgery, enhancing healing and patient comfort without the need for removal...

Johnson & Johnson’s TAR-200 for Bladder Cancer Granted FDA Priority Review

NDA for TAR-200 targets high-risk non-muscle invasive bladder cancer, highlighting potential to transform treatment for patients unresponsive to BCG therapy...

Texas Cardiac Arrhythmia Institute Becomes First in U.S. to Use FDA-Approved Wireless System for Arrhythmia Treatment

St. David's Medical Center pioneers clinical use of innovative wireless EP solution, marking a new chapter in minimally invasive cardiac care....

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....