Invictus Medical has submitted a De Novo application to the FDA for its Neoasis incubator-based active noise control device. FDA clearance is an essential step in the commercialization process of all medical devices, and this type of application is used for first-of-kind medical devices.
“With this submission, Invictus has made a huge step towards deploying the Neoasis active noise control 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,” says George Hutchinson, Invictus Medical’s CEO. “The Invictus team and our regulatory partners at ProximaCRO have prepared a substantial submission with guidance from the FDA and we’re optimistic about a smooth review process.”
After a series of pre-submission consultative meetings with the FDA, Invictus Medical amassed comprehensive performance and safety data covering a wide range of conditions for the application. Pre-submission meetings are conducted to expedite the review process by establishing the FDA’s expectations prior to the submission.
“Excessive environmental noise has long been a concern for NICU admitted preterm infants due to the duration of their hospital stay, the constant exposure to alarms, and the exposure from noise secondary to ventilators and other respiratory equipment,” says Kaashif Ahmad, MD, of Pediatrix Neonatology of Houston, co-author of a study on the Neoasis performance. “Existing mitigation measures for neonatal noise exposure are inadequate.”
The Neoasis is in development and is not currently commercially available.
Invictus Medical aims to provide safe and effective medical products and high levels of service to the healthcare and consumer markets.
