Alio Receives First FDA 510(k) Clearance

Press Release

Alio takes steps toward making better chronic care management a reality

BROOMFIELD, Colo., April 13, 2022— Today, Alio Inc., announced it received FDA 510(k) clearance for its remote monitoring system intended for use by healthcare professionals to intermittently collect physiological data in home use settings. Collected physiological data includes skin temperature, auscultation sound data and heart rate.

Alio technology provides real-time, 24/7, noninvasive remote patient monitoring. By sharing clinical data, Alio makes it possible for caregivers and clinicians to enable better patient care. The Alio SmartPatch can potentially serve as a remote patient monitoring system for a number of conditions.

“Remote patient monitoring is by no means a new concept in the patient care landscape but advancements in the technology that’s deployed have lagged behind,” said Richard Neville, MD, Chairman of the Department of Surgery at Inova and Director of Inova Vascular. “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 submissions for the company. 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 such end stage kidney disease (ESKD), patients undergoing hemodialysis, and patients with heart failure and peripheral vascular disease.

At present, Alio’s primary focus is the management of ESKD which is not just a technological challenge but one which continues to expand in scope – almost 150,000 new patients start dialysis each year in the USA and arguably more need dialysis treatment. In fact, The National Institutes of Health estimates that 9 out of 10 people in the US who have chronic kidney disease don’t realize it.

Eric Hargan, former HHS Deputy Secretary commented on the relevance of the Alio 510(k) clearance in hemodialysis patients, “a lot of progress has been made in recent years to improve care for dialysis, such as CMS continuing to expand its reimbursement for remote patient monitoring technologies, and the CURES Act mandating dialysis patients be given access to Medicare Advantage plans. The tragic reality is that many patients may unnecessarily end up in the hospital, while we as a country spend $14 billion on dialysis-related hospitalizations, 65% of which are preventable.  Alio is poised to make a significant impact in decreasing hospitalizations and improving dialysis patients’ quality of life.”

“Alio is driven by innovation. 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,” said David Kuraguntla, Chief Executive Officer of Alio. “We are thrilled to have reached this important milestone as a company, it truly makes our vision feel even closer to reality.”

About Alio

Alio Inc. is a medical technology company developing SmartPatch technology and using artificial intelligence (AI) to monitor multiple chronic indications, including end stage kidney disease (ESKD) patients undergoing hemodialysis.  Alio is dedicated to the development of tools and products for monitoring multiple metrics and providing actionable clinical data for a variety of conditions to better target interventions for improved outcomes and reduced hospitalizations.  The company’s products include SmartPatch and its remote monitoring system, which provides clinical data based on continuous monitoring of multiple metrics. Alio has an experienced management team with extensive experience in medical technology and devices.


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