Bellabeat Begins Application Process with The FDA For Bellabeat Ivy Certification

NEW YORK, Feb. 17, 2022 /PRNewswire/ -- Bellabeat Inc., (https://bellabeat.com/), a leader in creating wellness technology aimed exclusively at women, announced today that they have started the process of submitting an official application to the FDA for their product the Bellabeat Ivy. Obtaining a license from the U.S. Food and Drug Administration (FDA) would allow doctors and clinicians to officially use the Ivy wearable technology to monitor the menstrual cycle in the treatment of women. The Bellabeat Ivy is specifically made for women and has been seen in recent coverage as an outstanding health tracker to monitor and track a woman's menstrual cycle, fertility, postpartum depression symptoms, menopause symptoms, and more. The Ivy monitors the body's reactions and daily habits continuously during both the day and night through a set of advanced sensors. In turn, providing women with a complete insight into the pace of life. Elegantly designed, The Ivy is a smart bracelet and one gem of a find retailing at $249 on bellabeat.com and is available in a multitude of gorgeous different colors. FDA approval will allow the use of all IVY features such as recording the activity of the heart and breathing, sleep, menstrual cycle, and all other indicators of complete psychophysical condition, in clinics and offices as a verified medical product.

"Ivy is a product that can help women on so many levels and we are thrilled about taking the next steps in applying our physical response monitoring technology to treatment for women." said Urška Sršen, Co-founder of Bellabeat "We understand that the approval and certification process for medical devices in the United States can take up five years and are taking care with our trials to ensure that there are no foreseeable delays. We are excited to be a strong player leading the charge for the monitoring and treatment of all things Women's health." 

The Bellabeat Ivy, which is in this initial phase of obtaining the data required for registration with the FDA, is already being used as an adjunct in the treatment of women in a private clinic in Florida and is currently expanding to be used in three to four more. For now, these therapies are in psychiatry and mostly for the treatment of depression and anxiety. Clinical trial doctors are now using the Ivy to collect data on the patient before and after drug therapy, and using their independent interpretation of such data to determine the best therapy and treatment plans. During treatment, if relaxation drugs, breathing techniques, meditation, or more are used in therapeutical treatment, doctors can now monitor their effect via the Ivy.

"This year, Bellabeat will establish cooperation with about fifty clinics in the world. For now, the cooperation is focused on women's mental health, and after psychotherapy, we will go to other areas of medicine, "explained Sandro Mur, Co-founder of Bellabeat.

The Bellabeat Ivy's key features include:

• A Daily Readiness Score
• A Wellness Score
• Heart Rate & Fitness levels
• Respiratory Rate
• Cardiac Coherence
• Hydration
• Unmatched Cycle Tracking
• Mindfulness
• Activity
• Sleep Tracking
• The App Provides A Wealth of Meditations, A Coach, Dietary Suggestions, Quick Recipes, and more.

For media inquiries on the Bellabeat Ivy or its participating athletes in conjunction with it, please email [email protected] or call 877.841.7244.

About Bellabeat

Bellabeat Inc. is a Silicon Valley company building tech-powered wellness products for women. The Bellabeat team previously released the disruptive Leaf health tracking jewelry for women and the first smart water bottle powered by AI. Bellabeat is now revolutionizing the FemTech space by taking natural cycles into account when creating its guided programs and Ivy Smart Bracelet, helping women reach their health goals more effectively and enjoyably. Visit https://bellabeat.com/ for additional information.

Media Contact: Monique Tatum
BPM-PR Firm
Office: 1.877.841.7244
[email protected]

SOURCE Bellabeat Inc.