QART MEDICAL – FDA Registration

QART Medical is excited to announce a major milestone for our company: We have registered our flagship product, the Q300TM with the United States Food and Drug Administration (FDA). The Q300TM 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 Q300TM 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 Q300TM to detect, measure, and quantitatively analyze sperm cells, providing objective information in real-time to aid in the sperm selection process.

Before registration, the Q300TM has undergone numerous technical and biological safety tests in leading qualified labs around the world. The performance of the Q300™ is currently being evaluated in a multi-center clinical study in five IVF clinics and enrollment is expected to be completed before the end of 2022.

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