Masimo Gains Additional FDA Clearance for RD SET Sensor

Masimo’s RD SET sensor has received FDA’s 510(k) clearance for improved oxygen saturation accuracy specifications for neonates.

The updated sensor features better oxygen saturation accuracy for neonatal patients under 6.6 pounds both when they are still and moving, monitoring them to see how efficiently oxygen is being sent to different body parts.

The lightweight device connects to the patient’s foot or hand. It has been demonstrated to reduce severe retinopathy of prematurity in neonates, an eye disease that can cause blindness.