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. By defining a new class of active noise control devices, Invictus has now established the special requirements for this entire device class.
“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,” said George Hutchinson, Invictus Medical’s Chief Executive Officer. “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.”
“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,” said Dr Kaashif Ahmad of Pediatrix Neonatology of Houston, co-author of a study on the Neoasis™ performance. “Existing mitigation measures for neonatal noise exposure are inadequate.”
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.
Source: Company Press Release
