Regulatory

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....

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. ...

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....

Medtronic Secures FDA Approval for BrainSense™ Adaptive DBS, Pioneering Largest BCI-Enabled Therapy Launch

New real-time, self-adjusting deep brain stimulation system transforms Parkinson’s care with personalized neuromodulation...

Japan Approves Sarclisa-VRd for Newly Diagnosed Multiple Myeloma Patients

Regulatory green light follows IMROZ Phase 3 study results showing significant progression-free survival benefit...

CathVision Secures CE Mark for ECGenius System, Expanding Electrophysiology Solutions Across Europe

With CE Mark approval, CathVision’s AI-powered ECGenius System is set to launch in the European market, enhancing real-time electrogram recording and clinical decision-making for healthcare providers....

EMA Approves Takeda’s TAKHZYRO Pre-Filled Pen for Subcutaneous Administration in Adolescent and Adult HAE Patients

The new 2 mL pre-filled pen option expands individualized treatment choices for hereditary angioedema (HAE) patients, reinforcing Takeda’s commitment to reducing disease burden and improving quality of life....

IceCure Medical Seeks Israeli Regulatory Approval for Next-Gen XSense™ Cryoablation System

Building on FDA clearance, IceCure files for Israeli approval of its XSense™ System, expanding minimally invasive cryoablation solutions across multiple medical specialties in line with the growing trend of surgical de-escalation. ...