Regulatory

Baird Medical Gains Indonesian Regulatory Approval for Microwave Ablation Technology

Approval paves the way for broader adoption of Baird Medical’s minimally invasive treatment for tumor ablation, expanding access to advanced cancer care in Indonesia. ...

Beckman Coulter Secures FDA Clearance for DxC 500i Clinical Analyzer

The integrated clinical chemistry and immunoassay system enhances efficiency, streamlines lab workflows, and delivers accurate diagnostics in a compact design....

SkinCure Oncology Submits GentleBeam™ for FDA Clearance, Expanding Noninvasive Skin Cancer Treatment

GentleBeam™ aims to enhance Image-Guided SRT for nonmelanoma skin cancer, reinforcing SkinCure Oncology’s commitment to patient-centered, nonsurgical care. ...

Zimmer Biomet Wins FDA Nod for Metal-Safe Knee Implant

Zimmer Biomet Secures FDA Clearance for Persona® Revision SoluTion™ Femur, Expanding Options for Metal-Sensitive Knee Implant Patients...

Optellum and Volpara Health Partner to Enhance AI-Driven Cancer Risk Assessment

Strategic agreement integrates Optellum’s AI-powered lung nodule analysis with Volpara’s early cancer detection tools, enabling a more comprehensive approach to patient risk evaluation....

NAMSA acquires WuXi AppTec’s US medical device testing operations to expand expertise and capacity

The acquisition strengthens NAMSA’s leadership in medical device biological safety testing, adding expertise, lab capacity, and scientific resources to support global manufacturers....

South Korea’s DeepQure Advances Global Clinical Trials for Innovative RDN Technology

Pioneering Extravascular Renal Denervation for Resistant Hypertension ...

Sebelas Miudella™ Becomes First FDA-Approved Hormone-Free IUD in 40 Years

Offering a long-acting, non-hormonal birth control option, the approval marks a significant milestone in expanding contraceptive choices for individuals seeking hormone-free alternatives. ...

1 in 3 at Risk: Cardiologists Urge Global Action on Pulse Day to Tackle Silent Epidemic of Heart Rhyhm Disorders

With cases of atrial fibrillation and other heart rhythm disorders rising rapidly, the European Heart Rhythm Association (EHRA) calls for greater awareness and early detection—starting with a simple pulse check on 1 March....

Arcuro Medical Secures FDA 510(k) Clearance for SuperBall-RC™ Rotator Cuff Repair System

New device simplifies graft fixation, enhancing rotator cuff repair outcomes with a planned launch in 2025....