FDA Marketing Clearance of its ZILOS-tk® ZonaLaser Drill
for Additional Clinical Applications of Blastomere Biopsy and Trophectoderm Biopsy
(sz) Hamilton Thorne Biosciences Announces Third-round FDA Marketing Clearance of its ZILOS-tk® Zona Laser Drill for Additional Clinical Applications of Blastomere Biopsy and Trophectoderm Biopsy.
Hamilton Thorne Biosciences reported [today – ed.] that it has received third-round FDA marketing clearance for additional clinical applications for its ZILOS-tk® zona laser drill. The ZILOS-tk® is now the only non-contact laser device to be awarded marketing clearance for zona-pellucida drilling for blastomere biopsy and trophectoderm biopsy of human embryos in clinical applications. The ZILOS-tk was the first laser granted clearance for laser-assisted hatching of human embryos.
Both blastomere biopsy and trophectoderm biopsy are used in the practice of preimplantation genetic diagnosis (PGD), which determines the genetic composition of the embryo and ascertains whether it carries any disease-producing mutations. One or more embryos free of conditions that would cause serious disease may then be implanted in a woman’s uterus. more…
From: »Business Wire« (press release)