Regulatory

FDA Approves First Medical Device for Asherman Syndrome Treatment

FDA Approves Henlius-Organon Denosumab Biosimilars for Osteoporosis and Bone Cancer Treatment

Fairtility Receives FDA Clearance for AI-Powered Embryo Assessment Tool

AbbVie Receives UK MHRA Approval for Ovarian Cancer Treatment ELAHERE

Neuspera Wins FDA Approval for Battery-Free Sacral Neuromodulation Device for Bladder Control

Femasys Receives European Approval for FemBloc Non-Surgical Permanent Birth Control

Inne Receives UK and European Approval for Novel Saliva-Based Contraception Method

Clairity Receives First FDA De Novo Authorization for AI-Based Breast Cancer Risk Prediction Platform

Overture Life’s Automated Fertility Preservation Platform Receives Regulatory Clearance in Brazil

FDA Approves Teal Health’s At-Home Cervical Cancer Screening Device

German Cycle Tracking App Ovy Receives MDR Certification as Contraceptive Medical Device

Ark Surgical Receives FDA Clearance for Dual-Wall System in Gynecologic Surgery

Visby Medical Receives FDA De Novo Authorization for First-Ever OTC PCR Test for Women’s Sexual Health

FDA Approves First New UTI Antibiotic Class in 30 Years

PeriGen’s AI-Powered Fetal Monitoring System Receives FDA Clearance for Use from 32 Weeks

FemPulse Receives FDA Clearance to Begin Pivotal Trial for Women’s Overactive Bladder Device

BrightHeart Receives FDA Clearance for AI-Powered Fetal Heart Ultrasound Software

AbbVie’s ELAHERE Receives EU Approval for Treating Platinum-Resistant Ovarian Cancer

FDA Approves Genentech’s Itovebi for Advanced Breast Cancer with PIK3CA Mutation

Femasys Receives FDA Clearance for FemChec, Its Diagnostic Tool for Fallopian Tube Evaluation

Menstrual Care Company Sunny Earns FDA Clearance for Its Sunny Cup + Applicator