Regulatory

December 17, 2025
BlueWind Medical Receives FDA Clearance for Updated Revi Wearable for Urinary Incontinence
December 17, 2025
Flow Neuroscience Receives FDA Approval for At-Home Brain Stimulation Device for Depression
November 25, 2025
Overture Life Receives CE Mark for DaVitri Automated Egg Freezing Platform
November 14, 2025
Hologic’s Digital Pathology System Gains Expanded CE Marking for Cervical and Breast Cancer Diagnostics
November 3, 2025
Pulsenmore Receives FDA De Novo Authorization for Home Prenatal Ultrasound Device
October 24, 2025
Alife Health Receives CE Mark for AI-Powered Embryo Selection Tool
September 16, 2025
FDA Approves First Medical Device for Asherman Syndrome Treatment
September 5, 2025
FDA Approves Henlius-Organon Denosumab Biosimilars for Osteoporosis and Bone Cancer Treatment
September 3, 2025
Fairtility Receives FDA Clearance for AI-Powered Embryo Assessment Tool
August 15, 2025
AbbVie Receives UK MHRA Approval for Ovarian Cancer Treatment ELAHERE
July 17, 2025
Neuspera Wins FDA Approval for Battery-Free Sacral Neuromodulation Device for Bladder Control
June 25, 2025
Femasys Receives European Approval for FemBloc Non-Surgical Permanent Birth Control
June 19, 2025
Inne Receives UK and European Approval for Novel Saliva-Based Contraception Method
June 3, 2025
Clairity Receives First FDA De Novo Authorization for AI-Based Breast Cancer Risk Prediction Platform
May 14, 2025
Overture Life’s Automated Fertility Preservation Platform Receives Regulatory Clearance in Brazil
May 9, 2025
FDA Approves Teal Health’s At-Home Cervical Cancer Screening Device
April 29, 2025
German Cycle Tracking App Ovy Receives MDR Certification as Contraceptive Medical Device
April 22, 2025
Ark Surgical Receives FDA Clearance for Dual-Wall System in Gynecologic Surgery
April 7, 2025
Visby Medical Receives FDA De Novo Authorization for First-Ever OTC PCR Test for Women’s Sexual Health
March 28, 2025
FDA Approves First New UTI Antibiotic Class in 30 Years
February 24, 2025
PeriGen’s AI-Powered Fetal Monitoring System Receives FDA Clearance for Use from 32 Weeks
December 16, 2024
FemPulse Receives FDA Clearance to Begin Pivotal Trial for Women’s Overactive Bladder Device
November 18, 2024
BrightHeart Receives FDA Clearance for AI-Powered Fetal Heart Ultrasound Software
November 18, 2024
AbbVie’s ELAHERE Receives EU Approval for Treating Platinum-Resistant Ovarian Cancer