We are proud to announce that our flagship product FOLLISCAN has officially received FDA 510(k) clearance.
This milestone positions our company among an elite group of global innovators who meet the world’s most rigorous medical safety standards. This milestone marks a critical turning point in addressing one of the most persistent challenges in the field: the need for standardized, high-precision follicle analysis in a high-pressure clinical environment.
What is FOLLISCAN?
FOLLISCAN is a sophisticated Software as a Medical Device (SaMD) designed to support clinicians in the analysis of ovarian follicles. Using advanced artificial intelligence, the system automates the:
- Detection of follicles
- Counting and categorization
- Measurement of follicles to ensure clinical precision
Streamlining these tasks, FOLLISCAN enhances work efficiency and ensures consistent, high-quality assessments, allowing fertility specialists to focus more on patient care and less on manual data entry.
Read more about FOLLISCAN here
Why FDA 510(k) Clearance Matters
The U.S. Food and Drug Administration (FDA) is the global benchmark for medical safety. Receiving FDA 510(k) clearance confirms that Folliscan is safe, effective and substantially equivalent to legally marketed devices, but with the added power of modern AI.
FDA 510(k) clearance is not a formality. It means our algorithms were tested against stringent regulatory standards, our software performs reliably in real clinical conditions and our development processes meet medical-grade quality requirements. For our partners, it means one thing: FOLLISCAN is ready.
What This Means for the World of IVF
- For Clinics: Access to a rare, high-tech tool that standardizes ultrasound analysis.
- For Patients: Greater peace of mind knowing their treatment is supported by FDA-vetted technology.
- For the Industry: A major step forward in making AI-assisted reproductive medicine a global reality.
For MIM FERTILITY this clearance is especially significant because the number of comparable FDA-cleared AI technologies in reproductive medicine remains incredibly limited.
FOLLISCAN now stands among an elite group of technologically advanced tools developed specifically for the real-world needs of modern reproductive medicine.
Why This is a Game-Changer
This clearance opens the U.S. market for FOLLISCAN and signals to international partners that the technology meets the world’s highest regulatory standard. It also serves as a foundation for global expansion, as FDA approval is a recognized seal of quality in almost every international market.
We want to thank our dedicated team of engineers, embryologists and clinical partners who made this possible. Behind every ultrasound image is a patient waiting for an answer. FOLLISCAN helps clinicians give that answer faster and with greater confidence. That’s what this clearance means to us.
Interested to test FOLLISCAN? Click here to request a demo
Our commitment
We recognize that behind every data point and ultrasound frame is a person navigating one of life’s most profound journeys. This drives us to maintain the highest standards of clinical integrity and transparency, ensuring that our AI remains a reliable, ethical and seamless partner in the exam room. By relentlessly pursuing global certifications like the FDA 510(k), we promise to provide clinicians with the most validated tools available, empowering them to deliver faster answers, more accurate insights and ultimately, a more hopeful path toward parenthood for patients worldwide.
