The US Food and Drug Administration (FDA) has granted 510(k) clearance to Irvine Scientific's newly developed Continuous Single Culture - Complete product (CSCM-C), designed for improving blastocyst formation.
CSCM-C, which is designed for laboratory use, is a complex solution which is pre-supplemented with Human Serum Albumin, intended to be used for fertilization and culture of embryos to D-3, or D-5/D-6 of development.
The optimized solution also reduces embryo stress by eliminating the need to expose embryos to varying media environments, temperature and pH fluctuations.
Irvine Scientific COO Tim Mullane said the company has developed a monoculture solution for both fertilization and extended embryo culture in an uninterrupted culture environment.
"CSCM-C represents an important addition to a series of innovative products offered by Irvine Scientific that provide a simplified and efficient approach to achieving pregnancies in-vitro," Mullane added.
"But more importantly, provides a complete solution for laboratories that strive to reduce embryo stress while providing patients with a healthy baby."