News

News

Mirabilis has completed a multi-center pilot study, investigating the use of the Mirabilis System for the treatment of uterine fibroids. The Mirabilis System is an ultrasound guided High Intensity Focused Ultrasound (HIFU) device. The study (NCT01946178) enrolled and treated 73 adult patients at clinical centers in Mexico City and Monterrey, Mexico. Interim data has been presented at symposia of the International Society of Therapeutic Ultrasound and at the European Society of Gynaecological Endoscopy annual congresses.
We are pleased to announce that Mirabilis has received ISO-13485 certification for its quality system, covering the "design and development, manufacture, distribution, installation and service of ultrasound devices for the non-invasive ablation of uterine fibroid tissue in the field of Gynecology."
ISO-13485 is an internationally recognized standard for quality systems covering medical devices, and is an important milestone in bringing the Mirabilis system to market in Europe and elsewhere. Audit and certification was performed by Dekra Certification, B.V.

Caution: The Mirabilis System has not been approved for sale or use in the United States.