FDA Clears TMRW Life Sciences’ IVF CryoRobot
New York-based fertility technology company TMRW Life Sciences’ CryoRobot Select has received 510(k) marketing clearance, making it the only FDA-cleared automated device that digitally monitors and manages frozen eggs and embryos for in vitro fertilization (IVF).
The device uses the company’s proprietary ivfOS software, which assigns a unique identifier for each specimen in the cryogenic process of freezing eggs, sperm or embryos. The automated system captures inventory in real-time and reduces potential manual points of failure.
"Until recently, we didn't ask how our frozen eggs or embryos were managed, unaware of how manual and archaic the systems have been until this point,” said TMRW Life Sciences CEO Tara Comonte. “Patients and clinicians are demanding innovations to make the [IVF] process safer, more transparent and more accurate," she said.