Royal Philips (NYSE:PHG) announced today that it received FDA emergency use authorization (EUA) for its IntelliVue patient monitors and active displays.
The Amsterdam-based company’s IntelliVue monitors MX750/MX850 and active displays AD75/D85 received authorization to support infection-control protocols and provide caregivers information remotely during the ongoing COVID-19 pandemic.
Both sets of IntelliVue products received CE Mark approval last year and the MX750 patient monitor already received EUA in April. The latest EUA allows Philips to begin delivering the remote monitoring products to hospitals in the U.S., while it is preparing to submit to the FDA for 510(k) clearance this year.
The monitors and active displays include Philips’ IntelliVue Horizon Trends information view that shows deviations in vital signs. It also features an alarm advisor and alarm reporting to reduce caregivers’ alarm fatigue. Philips noted in a news release that the systems have updated features, including strengthened cybersecurity functionalities.
“As the world continues to battle against COVID-19, we’re committed to ramping up production of all critical solutions that can help in this time of crisis,” Philips GM of motoring & analytics Peter Ziese said in the release. “This FDA EUA for our MX750 and MX850 monitors and IntelliVue AD75 and AD85 active displays allows us to do that for these remote patient monitoring solutions, which are of vital need in the ICU.
“At Philips, being able to provide the right information at the right time to caregivers has always been a top priority. Now more than ever, there’s an urgent need to make sure those on the frontline have all the available resources at their disposal.”