(Image from Philips)

Royal Philips (NYSE:PHG) announced that it has won FDA 510(k) clearance for a wearable biosensor to help manage confirmed and suspected COVID-19 patients in the hospital.

The Amsterdam-based company described the BX100 biosensor as a wireless wearable sensor designed to help healthcare providers detect when COVID-19 patients in lower-acuity units are at risk for deterioration so they can intervene.

The lightweight, disposable biosensor is a 5-day, single-use wearable patch can be integrated with a scalable hub to monitor multiple patients across different rooms, according to Philips. It is designed to adhere discreetly to the chest to collect, store, measure and transmit respiratory rate and heart rate every minute — the top two predictors of deterioration — as well as contextual parameters such as posture, activity level and ambulation. The sensor is built to work with existing clinical workflows for mobile viewing and notifications and requires no cleaning or charging.

The biosensor has already received the CE Mark, and is being used at a hospital in the Netherlands to help manage the triage and clinical surveillance of COVID-19 patients, according to Philips.

“During this unprecedented time of COVID-19, the Philips biosensor BX100 helps provide rapid deployment for clinical surveillance to help decrease risk of exposure of healthcare workers while acquiring frequent patient vitals, and easing the demand for personal protective equipment (PPE),” said Peter Ziese, GM of monitoring and analytics at Philips. “The biosensor is an integral component in our patient deterioration detection solution which helps aid in the identification of the subtle signs of deterioration in a patient’s condition at the point of care, hours before a potential adverse event would occur.”