FDA approves BEI's ThermAblator sheath changes:
This article was originally published in Clinica
Executive Summary
The US FDA has given BEI Medical Systems the green light to incorporate cost-saving modifications to the way that it assembles the sheath used in its Hydro ThermAblator (HTA) procedure set for treating excessive menstrual bleeding. "The allowance of this modification is an important step in our ongoing objective to reduce production costs of the HTA single-patient-use procedure set, which is expected to result in eventual savings of approximately 50% as production volumes accelerate," said the Teterboro, New Jersey firm.