• Skip to main content
  • Skip to secondary menu
  • Skip to primary sidebar
  • Skip to secondary sidebar
  • Skip to footer

  • Opinion
  • Health IT
    • Behavioral Health
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Patient Engagement
    • Population Health Management
    • Revenue Cycle Management
    • Social Determinants of Health
  • Digital Health
    • AI
    • Blockchain
    • Precision Medicine
    • Telehealth
    • Wearables
  • Life Sciences
  • Investments
  • M&A
  • Value-based Care
    • Accountable Care (ACOs)
    • Medicare Advantage

FemTech: Mosie Baby Awarded FDA Clearance for At-Home Intravaginal Insemination

by Syed Hamza Sohail 12/06/2023 Leave a Comment

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

What You Should Know:

  •  Mosie Baby, a pioneering at-home fertility care company, has secured FDA Class II clearance for its Mosie Baby Kit making it the first and only FDA-cleared over-the-counter kit for use in intravaginal insemination (IVI).
  • The kit was created to support those who are unable to conceive with intercourse or for whom intercourse is not an option. Following its FDA 510k Class II clearance, Mosie Baby looks forward to expanding access to its Mosie Baby Kit which was determined to be “substantially equivalent” to a predicate device used in clinically-administered intrauterine insemination (IUI).

FDA-Cleared Over-The-Counter Kit for Intravaginal Insemination

The Mosie Baby Kit is designed for at-home insemination with either fresh or cryogenically frozen donor semen samples. Each kit includes two patented syringes with a barrel-free tip and slit opening for optimal transfer and minimal waste. Additionally, two proprietary collection cups are provided for semen collection, featuring a design that supports maximum collection. The kit has received FDA Class II clearance after rigorous clinical and technical testing, including Human Sperm Survival Assay, vaginal irritation testing, and biocompatibility testing. Mosie Baby confirmed that the device is non-cytotoxic, non-irritating, non-sensitizing, and free from microbial contamination through these tests.

“Nearly 10 years ago, my husband and I were devastated by a diagnosis of unexplained infertility and were desperate for options that were safe, financially accessible and easy to use at home,” said co-founder and CEO Maureen Brown. “Since inventing the Mosie Baby Kit in 2014, we realized we weren’t alone in our fertility journey as it’s reported that one in six people experience infertility. To date, we’re very proud to share that Mosie Baby has helped more than 100,000 families inseminate from the comfort of their own home.  We are now thrilled to offer our device as an FDA reviewed option for families looking to inseminate at home.”

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

Tagged With: FDA Clearance, FDA clearance 510k, Femtech

Tap Native

Get in-depth healthcare technology analysis and commentary delivered straight to your email weekly

Reader Interactions

Primary Sidebar

Subscribe to HIT Consultant

Latest insightful articles delivered straight to your inbox weekly.

Submit a Tip or Pitch

Featured Interview

Reach7 Diabetes Studios Founder Chun Yong on Reimagining Chronic Care with a Concierge Medical Model

Most-Read

HHS Finalizes HTI-4 Rule: Prior Authorization & E-Prescribing Interoperability

HHS Finalizes HTI-4 Rule: Prior Authorization & E-Prescribing Interoperability

Meaningful Use Penalties_Meaningful Use_Partial Code Free_Senators Urge CMS to Establish Clear Metrics for ICD-10 Testing

CMS Finalizes TEAM Model: A New Era of Value-Based Surgical Care

White House Event Unveils CMS Health Tech Ecosystem Initiative

White House Event Unveils CMS Health Tech Ecosystem Initiative

Digital Health Faces Q2'25 Pullback: Funding Falls to 5-Year Low, But AI Dominates and $1B+ IPOs Emerge

Healthcare Investment Shifts in 1H 2025: AI Remains a Bright Spot Amidst Fundraising Decline

Digital Health Faces Q2'25 Pullback: Funding Falls to 5-Year Low

Digital Health Faces Q2’25 Pullback: Funding Falls to 5-Year Low

Beyond the Hype: Building AI Systems in Healthcare Where Hallucinations Are Not an Option

Beyond the Hype: Building AI Systems in Healthcare Where Hallucinations Are Not an Option

Health IT Sector Navigates Policy Turbulence with Resilient M&A

Health IT’s New Chapter: IPOs Return, Resilient M&A, Valuations Rise in 1H 2025

PwC Report: US Medical Cost Trend to Remain Elevated at 8.5% in 2026

PwC Report: US Medical Cost Trend to Remain Elevated at 8.5% in 2026

Philips Launches ECG AI Marketplace, Partnering with Anumana to Enhance Cardiac Care with AI-Powered Diagnostics

Philips Launches ECG AI Marketplace, Partnering with Anumana to Enhance Cardiac Care with AI-Powered Diagnostics

WeightWatchers Emerges from Bankruptcy, Launches New Menopause Program

WeightWatchers Emerges from Bankruptcy, Launches New Menopause Program

Secondary Sidebar

Footer

Company

  • About Us
  • Advertise with Us
  • Reprints and Permissions
  • Submit An Op-Ed
  • Contact
  • Subscribe

Editorial Coverage

  • Opinion
  • Health IT
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Population Health Management
    • Revenue Cycle Management
  • Digital Health
    • Artificial Intelligence
    • Blockchain Tech
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • Value-Based Care
    • Accountable Care
    • Medicare Advantage

Connect

Subscribe to HIT Consultant Media

Latest insightful articles delivered straight to your inbox weekly

Copyright © 2025. HIT Consultant Media. All Rights Reserved. Privacy Policy |