QART MEDICAL – FDA Registration

QART Medical is excited to announce a major milestone for our company: We have registered our flagship product, the Q300™ with the United States Food and Drug Administration (FDA). 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.

Before registration, the Q300™ 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.