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March 16, 2022

Philips receives FDA 510(k) clearance for Capsule Surveillance solution

The new solution can use streaming data from any connected medical device virtually.

Royal Philips has received 510(k) clearance from the US Food and Drug Administration (FDA) for its latest Capsule Surveillance solution.

The new solution is designed to aggregate and analyse patient data to produce actionable insights.

It also alerts and sends notifications to patient caregivers, allowing them to intervene before deterioration progresses further.

Furthermore, the Philips Capsule Surveillance solution has the capability to use streaming data from any connected medical device virtually.

Philips stated that the new release of the software covers additional use cases and new ways to access patient information.

The software can be used with existing mobile clinical communication and collaboration tools at hospitals, electronic intensive care units (eICUs) and virtual care population health management systems.

This gives clinicians better visibility into live streaming data, device alarms, contextual alerts and waveforms.

Philips Clinical Data Services general manager Elad Benjamin said: “This FDA clearance of the latest release of clinical surveillance solution enables more integrated viewing options within electronic medical records (EMR) and health information technology (HIT) tools through the secure web-based user interface.

“The updated intended use provides flexible deployment configurations that Philips Capsule can offer to hospitals and health systems in the USA.

“Properly implemented clinical surveillance has the potential to significantly improve patient outcomes by helping to avoid deterioration, while also improving the care team experience via clinical decision support and minimising the burden of false and clinically unactionable alarms.”

The Philips Capsule Surveillance can reduce the risks for clinical staff treating infectious patients.

It also provides early identification of deteriorating patient conditions, which helps to reduce care costs and use resources efficiently by avoiding escalations and complications.

Philips plans to release the latest version of the surveillance solution to limited sites in the US in the second quarter of the year.

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