Alio remote monitoring technology receives first FDA 510(k) clearance

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Alio has announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its remote monitoring system, which is intended for use by healthcare professionals to intermittently collect physiological data—including skin temperature, auscultation sound data and heart rate—in home use settings.

The company’s technology provides real-time, 24/7, non-invasive remote patient monitoring and, by sharing clinical data, is intended to make it possible for caregivers and clinicians to enable better patient care. The Alio SmartPatch device can potentially serve as a remote patient monitoring system for a number of conditions, a company press release notes.

“Remote patient monitoring is by no means a new concept in the patient care landscape, but advancements in the technology that is deployed have lagged behind,” said Richard Neville (Inova Health System, Falls Church, USA). “Patients should be able to benefit from the latest innovations technology has to offer. The Alio clearance is a step in the right direction in terms of ushering in a new era of remote patient monitoring.”

This is the first of several intended regulatory submissions for the company, the release notes. Currently, Alio is undergoing clinical investigations to assess additional indications for use in remote patient monitoring of electrolytes, fluid management, and fistula status, and specific patient populations, such as chronic care patients with conditions like end-stage kidney disease (ESKD), patients undergoing haemodialysis, and patients with heart failure and peripheral vascular disease. At present, however, Alio’s primary focus is the management of ESKD.

“Alio is driven by innovation,” said David Kuraguntla, CEO of Alio. “Since the founding of Alio, we have always known that remote patient monitoring with Alio can improve patient outcomes and increase the likelihood of a better quality of life at a lower cost to the healthcare system. We are thrilled to have reached this important milestone as a company—it truly makes our vision feel even closer to reality.”

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