Raanana, Israel – QART Medical has met another major regulatory milestone in its corporate strategy. QART’s flagship product, the Q300™, now bears the CE (Conformité Européenne) Mark, indicating declared conformity with regulations applicable to the product. This achievement follows approval from the Israeli Ministry of Health (a.k.a AMAR) and registration of the Q300™ with the US-FDA, allowing QART to market and sell the Q300™ United States, the EU and Israel.
Q300™ is a QPM (quantitative phase microscope) based optical imaging system for analysis and selection of individual sperm cells for IVF (in vitro fertilization). Q300™ performs morphological human sperm cell analysis that provides high resolution 3D imaging of sperm cell structure and internal organelles. Q300™ empowers embryologists to make objective, quantitative, recorded, and highly-informed decisions about the sperm cells that they intend to select for injection into oocytes during the most prevalent IVF procedure, ICSI (intra cytoplasmic sperm injection).
Q300™ utilizes state-of-the-art digital-holographic-microscopy, advanced image processing algorithms, machine vision and complete log and traceability of each sperm cell that is analyzed and considered for injection. These unique offerings position the Q300™ to revolutionize the ability to detect, measure, and quantitatively analyze sperm cells, providing objective information in real-time to aid in the sperm selection process.
A multi-center clinical outcome study, exploring the impact of using the Q300™ on IVF success is now on-going. Initial clinical outcome results are highly favorable. “We are pleased with the CE Mark and are eager to bring the QART’s groundbreaking technology to the European market”, said QART Medical’s CEO and co-founder Alon Shalev.
About QART Medical
QART Medical is an ISO13485 certified MedTech company addressing the global infertility epidemic. To do so, QART has developed the Q300™, a breakthrough solution to male infertility issues that provides a quantitative characterization of sperm cell morphology to facilitate informed clinical decision making when selecting cells for use in in-vitro fertilization (IVF). QART aims to improve current success rates of Intra-Cytoplasmic Sperm Injection (ICSI) by quantitatively characterizing the morphology and composition of individual sperm cells with 3D imaging. The Q300™ is registered with the US FDA, has received Israeli regulatory registration for commercial sales, and bears the CE (Conformité Européenne) Mark.