Regulatory

Autonomix Medical Secures New U.S. Patent for Advancing Nerve-Targeted, Minimally Invasive Therapies

Patent strengthens company’s IP portfolio as it expands innovative treatments for chronic pain, oncology, and other high-need conditions ...

Takeda Secures FDA 510(k) Clearance for HyHub™ and HyHub™ Duo Devices

New devices designed to streamline and personalize HYQVIA® administration for patients receiving subcutaneous immune globulin therapy...

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. ...