Product News: Irvine Scientific Receives FDA Clearance for Novel Human Embryo Culture Solution

21 Sep 2012

Irvine Scientific, a global leader in Assisted Reproductive Technologies (ART), has announced that it has received 510(k) clearance from the FDA for its Continuous Single Culture™ - Complete product (CSCM-C). The company will commence commercialization at IVF centers across the United States immediately.

CSCM-C 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. CSCM-C is the first and only single-step culture medium used in an uninterrupted culture environment, without the need for medium renewal or dish change. Designed for laboratories who want to reduce stress on embryos while improving clinical results, the optimized formulation reduces embryo stress by eliminating the need to expose embryos to varying media environments, temperature and pH fluctuations. The new CSCM-C product improves blastocyst formation with a demonstrated increase in blastocyst utilization and fertilization rates.

“We are very pleased to be the first and only company at this time that offers a monoculture solution for both fertilization and extended embryo culture in an uninterrupted culture environment”, expresses Tim Mullane, COO. He adds that “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. But more importantly, provides a complete solution for laboratories that strive to reduce embryo stress while providing patients with a healthy baby. ”