Invictus Announces FDA Clearance of Ground-Breaking Neoasis ® ANC Device

First of its kind incubator-based device cleared for use by FDA

Summation

  • “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.
  • “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.
  • 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.

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.

Other FDA News of Interest

FDA Grants AI-Powered Notal Vision Home OCT “SCANLY” De Novo Marketing Authorization

“We are very excited to receive FDA authorization to market SCANLY Home OCT as the first-ever patient self-operated, home-use device that gives physicians remote access to high-resolution, cross-sectional retinal images and AI-based analytical biomarkers of their patients eyes between office visits,” said Kester Nahen, PhD, CEO of Notal Vision. “We look forward to supporting our referring physicians in navigating their wet AMD patients’ care.”

Atraverse Medical Receives FDA Clearance for HOTWIRE™ Left Heart Access Device, Oversubscribes Seed Round with $12.5M Invested

The HOTWIRE system, invented by Atraverse Medical Co-Founders Dr. Steven Mickelsen and Eric Sauter, introduces a paradigm shift in left-heart access.

RapidAI Secures FDA Clearance for Perfusion Imaging in the Angiography Suite

“We are pleased to expand our stroke AI imaging portfolio, the broadest in the industry, to include this new module. With AngioFlow™ by RapidAI, we can now support stroke AI imaging along the entire patient pathway, from the initial non-contrast CT scan all the way to the interventional suite,” said Karim Karti, CEO of RapidAI. “Already registered and used in Japan and Europe, we believe this technology will make a significant difference in the lives of U.S. stroke patients.”

By using this website you agree to accept Medical Device News Magazine Privacy Policy