Invictus Medical announced today that the culmination of their De Novo application to the FDA for its Neoasis® incubator-based active noise control (ANC) device has resulted in a clearance-for-use declaration by the FDA.
“With this clearance for use, Invictus has made a huge step towards deploying the Neoasis® ANC device in neonatal intensive care units. It is well documented that a quieter environment has a positive impact, including improved sleep hygiene and weight gain in infants where both are critical for development,” said George Hutchinson, Ph.D., Invictus Medical’s Chief Executive Officer.
The Neoasis utilizes a proprietary, innovative active noise control (ANC) system to attenuate noise with canceling sound wave technology. At the same time, it allows a parent’s voice to be directed to the infant, which can also be beneficial for cognitive development.
“The increasing sophistication of NICU care has created a burden of noxious stimuli for critically ill infants,” said Dr. Robert White, Practice Medical Director, Pediatrix Medical Group. “The rapidly growing auditory cortex of these neonates can only develop properly when background noise doesn’t interfere with nurturing sounds of parents and caregivers.”
The functionality and performance of the Neoasis® were highlighted in a recent presentation at the Pediatric Academic Society conference. “In our study, we sought to measure the level of noise reduction provided by commercially available neonatal ear covers in a simulated NICU environment and compare this to levels provided by this novel noise reduction device designed specifically for use in neonatal incubators,” explained Dr. Hutchinson.
“What was demonstrated and what our article shows is that the Neoasis® ANC device is effective over a broad area in the incubator and is superior to commercially available adhesive ear muffs. In previously published clinical studies, this level of noise attenuation resulted in improved sleep hygiene and rate of growth.”
Throughout the De Novo application process, multiple consultative meetings were conducted to expedite the review process and understand the FDA’s expectations. As a result, Invictus Medical amassed comprehensive performance and safety data covering a wide range of conditions for the application.
By defining a new class of active noise control devices, Invictus has now established the special requirements for this entire device class.
