Philips wins 510(k) for sensor to detect COVID-19 patient deterioration

(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 …

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Philips lands 510(k) to market ultrasound systems for COVID-19

The FDA has granted Royal Philips (NYSE:PHG) 510(k) clearance to market a wide range of its ultrasound systems to help manage COVID-19-related lung and cardiac complications.

Handheld and portable ultrasound solutions in particular have become valuable tools for clinicians treating COVID-19 patients due to their imaging capabilities, portability and ease of disinfection, according to Philips.

The 510(k) clearance, which Philips called an industry first, allows the Netherlands-based company to provide detailed, practical guidance to support clinicians using its systems and software for COVID-19 patients. The clearance applies to Philips’ EPIQ series, Affiniti series, Lumify, CX50 and Sparq diagnostic ultrasound systems, and to off-cart solutions like QLAB advanced quantification software.

Ultrasound has shown value in imaging peripheral lung tissue affected by pneumonia, which is closely tied to COVID-19 lung complications, according to Philips. As …

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