The only FDA-authorized therapeutic vibrational mattress for newborns with neonatal abstinence syndrome

On April 4, 2025 the FDA created a new category of medical devices by granting De Novo authorization to the Prapela SVS hospital bassinet pad.

The Prapela SVS hospital bassinet pad

Which is remarkable because for more than 50 years, water beds, air mattresses, swinging beds, bouncing chairs, swaying cribs, and massage devices have failed to gain FDA authorization to treat newborns in hospitals. So, what makes Prapela's bassinet pad different? It's the first mattress with a stochastic vibration.

Barely perceptible to the touch, Prapela's stimulation vibrates randomly with a precise motion and speed. So precise that the stimulation is measured with laser optics. Developed by Prapela Co-founder Dr. David Paydarfar, our stimulation was created to improve the detection of weak signals of the autnomic nervous system that drive breathing and heart rate. Ours is a stimulation therapy 30 years in the making, supported by mathematical modeling of human respiration and proven in randomized clinical trials. The first indication of the pad is for neonatal abstinence syndrome otherwise known as neonatal opioid withdrawal syndrome.

In future posts we'll be discussing more about our therapeutic stimulation and its application as an adjunctive therapy for opioid exposed newborns. Welcome to our blog!