Regulatory

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. ...Read more

10th March, 2025 | By Ankit Kankar | ankit.kankar@mmactiv.com 


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...Read more

10th March, 2025 | By Ankit Kankar | ankit.kankar@mmactiv.com 


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....Read more

05th March, 2025


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....Read more

04th March, 2025


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

Pioneering Extravascular Renal Denervation for Resistant Hypertension ...Read more

04th March, 2025


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. ...Read more

03rd March, 2025


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 Marc...Read more

03rd March, 2025


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....Read more

28th February, 2025


OrthoNovis Secures FDA Clearance for BPS Wrist Fracture System

The 510(k) clearance enables OrthoNovis to enter the U.S. orthopedic fracture fixation market with its innovative locking wrist plates, advancing treatment options for distal radius fractures and fusions. ...Read more

26th February, 2025


Averto Medical’s ColoSeal™ Wins FDA Breakthrough Device Designation for Colorectal Surgery

Minimally invasive ICD system aims to eliminate temporary ostomies, improving recovery and quality of life for patients undergoing colorectal surgery....Read more

26th February, 2025


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