Q300 Israeli Ministry of Health Medical Device Division (AMAR) Approval

QART Medical is excited to announce a major milestone for our company: Our flagship product, the Q300™ has received approval from the Israeli Ministry of Health Medical Device Division (AMAR) to be marketed and commercially sold in Israel. The Q300™ system 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).

The Q300™ is a first of its kind, clinically-adapted QPM (quantitative phase microscopy) system, which includes state-of-the-art image processing algorithms, machine vision and complete log and traceability of each sperm cell that is selected for injection.

These unique offerings uniquely position the Q300™ to detect, measure, and quantitatively analyze sperm cells, providing objective information in real-time to aid in the sperm selection process.

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 topographic imaging. The Q300™ is registered with the US FDA, has received Israeli regulatory registration for commercial sales, and is in the process of CE-Mark registration.