The receipt of FDA 510(k) clearance for Venus Freedom follows the recent receipt of Health Canada authorization to market the Venus Fiore Feminine Health System in July 2021
FDA Building 66 houses the Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration/Wikipedia)
Venus Concept Inc. (“Venus Concept” or the “Company”) (NASDAQ: VERO), a global medical aesthetic technology leader, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market the Venus Freedom device in the United States.
Venus Freedom is a noninvasive, non-ablative device with three applicators for the delivery of non-thermal radiofrequency energy combined with massage and magnetic field pulses. It is intended for the treatment of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.
“Following the receipt of Health Canada authorization for our Venus Fiore Feminine Health System in July, we are very pleased to further expand our portfolio of technologies that can treat a broad range of common women’s health conditions with the FDA 510(k) clearance of Venus Freedom,” said Domenic Serafino, Chief Executive Officer and Director of Venus Concept Inc. “Venus Concept devoted nearly six years to developing this technology in order to create a comprehensive, safe and effective system that has the ability to treat a variety of different women’s wellness issues, addressing important medical needs and supported with significant clinical data. We look forward to commencing a limited launch of the Venus Freedom in the U.S. during the first quarter of 2022. We intend to sell the Venus Freedom using a unique utilization-focused business model which we believe will make the return on investment of this system very attractive for both Venus Concept and the OBGYN community.”
The receipt of FDA 510(k) clearance for Venus Freedom follows the recent receipt of Health Canada authorization to market the Venus Fiore Feminine Health System in July 2021. In Canada, Venus Fiore is intended for women who are post-menopausal, or have undergone surgically induced menopause, and is intended to treat the vaginal canal to improve symptoms of vaginal laxity and for increased sexual function, skin tightening/improvement in skin laxity of the Mons Pubis (MP) anatomy and the Labia Majora (LA) anatomy and to improve blood flow.
Source: Company Press Release