Alio receives second FDA clearance


Alio, the medical technology company behind the SmartPatch device for chronic disease, has announced its latest US Food and Drug Administration (FDA) clearance. The company’s second clearance added three additional metrics to its remote patient monitoring platform—haematocrit, haemoglobin and potassium.

The platform consists of a SmartPatch, hub, and portal, which non-invasively capture clinical-grade metrics for care teams. Alio makes it possible for patients and their care teams to monitor their condition on an ongoing basis by issuing actionable notifications. With this clearance, the SmartPatch is cleared for use in monitoring key metrics including skin temperature, auscultation, heart rate, haematocrit, haemoglobin, and potassium.

While the technology can be deployed to monitor a number of chronic conditions, the company’s first area of focus is patients with end-stage kidney disease (ESKD). Until now, there has been little to no advancement in care management or innovative solutions for patients on dialysis and their care teams, an Alio press release states. Patients with ESKD, they add, are at particularly heightened risk for hospitalisations due to complications like fluid overload, dyskalemia, and more. Unfortunately, the current standard of care only monitors key metrics through a monthly blood draw whereas the Alio SmartPatch painlessly takes readings every few hours.

“This is such a pivotal moment for our organisation, one which is the culmination of years of hard work, the trust of our amazing clinical partners, and the backing of our forward-thinking investors,” said David Kuraguntla, CEO and co-founder of Alio. “When we began this journey we knew better care was possible but it would require purpose-built technology designed with altruistic intentions and the patient in mind. At Alio, we believe in a world where no patient with a chronic condition will have to wonder whether their health is being properly managed and no family member will have to say goodbye to a loved one too soon simply because they didn’t have insight into their own condition.”

Receiving this latest clearance means Alio’s technology is officially available for commercial deployment and will allow hospitals and health systems to bridge the gap in care by better connecting clinicians to their patients without requiring more frequent visits to any clinical site. This will ultimately drive down healthcare costs and help prevent adverse health events, particularly because 65% of dialysis-related hospitalisations are preventable. And, considering the average ESKD patient in the USA is hospitalised twice per year for an average of 11 days, creating a national spend of over US$12 billion, the potential is enormous.

“There are millions of people around the world with chronic kidney disease and, here in the USA alone, ESKD patients make up 1% of the Medicare population yet they account for 7% of Medicare spend,” said Eric Hargan, former deputy secretary of the Department of Health and Human Services. “We started KidneyX, a public-private initiative, for exactly this reason—so innovative organisations like Alio would be able to put powerful technology into the hands of patient populations who will benefit significantly. I’m thrilled to see Alio receive this latest clearance and I know this is just the beginning of the kind of impact they’ll be able to have on a global scale.”

Alio received its first FDA clearance in April 2022 and announced the initial close of its Series C funding round in December 2022.


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