US-based gynecologic medical devices company Meditrina has received the UKCA Mark and CE Mark approvals for its fully disposable Aveta Hysteroscopy System.
Hysteroscopy is a key diagnostic and therapeutic procedure intended to evaluate and treat conditions that affect the uterus.
Meditrina’s Aveta hysteroscopy system is designed to provide physicians with the best care in diagnosing and treating endometrial polyps and uterine fibroids.
It combines advanced technology with ergonomic design to help healthcare professionals perform minimally invasive procedures, with enhanced visualisation and control.
The UKCA and CE Mark approvals indicate that Meditrina’s hysteroscope meets the quality, safety, and efficacy standards for marketing in the EU and the UK.
The regulatory approvals validate its regulatory compliance and strengthen its position as a provider of advanced medical solutions, said the US medical device maker.
Meditrina CEO Csaba Truckai said: “We are excited to receive UKCA and CE Mark approval for our hysteroscopy system, as it validates the exceptional quality and performance of our product.
“Furthermore, the successful completion of our initial international procedures in Spain and Denmark signifies a significant milestone in our mission to revolutionize women’s healthcare on a global scale.
Meditrina introduced the Aveta Hysteroscopy System in 2019 and conducted inaugural procedures in Spain and Denmark.
The hysteroscopy suite comprises the single-use Aveta Pearl Hysteroscope for myomectomy and the single-use Aveta Coral Hysteroscope for polypectomy procedures.
The Aveta Pearl Hysteroscope is the first single-use hysteroscope to offer full physician control over fluid management and video control function directly on the hysteroscope handle.
Furthermore, it is well-positioned to capitalise on new market opportunities and forge strong partnerships with healthcare providers worldwide, said the medical devices company.
Truckai added: “We are proud to collaborate with healthcare providers worldwide in delivering advanced solutions that empower women to lead healthier lives.
“The UKCA and CE Mark approval and successful international procedures represent significant milestones for the company, and I am eager to lead our global sales efforts in bringing our innovative hysteroscopy system to healthcare providers around the world.”
