FDA Clears Alydia Health’s Postpartum-Bleeding Device

The FDA has given Alydia Health 510(k) clearance for its Jada system, a device that controls and treats postpartum hemorrhage (PPH) and abnormal postpartum uterine bleeding.

The system, a thin tube that is placed in the uterus, treats PPH and abnormal postpartum uterine bleeding using a gentle vacuum to induce the postpartum contraction that normally occurs after childbirth.

The technology “offers a mechanical alternative to uterotonic drugs, which are also intended to contract the uterus but are limited by contraindications and side effects in certain patients,” the company said.