Alio receives FDA 510(ok) for its distant affected person monitoring system


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Alio introduced it earned FDA 510(ok) clearance for its distant monitoring system that collects knowledge on pores and skin temperature, auscultation, or inside physique sounds, and coronary heart price.

The system, which obtained the greenlight in late March, is made up of the SmartPatch wearable sensor, its Bedside Hub which collects and uploads patch knowledge, the Alio Medical Cloud that shops that data, and a clinician-facing portal. 

Alio mentioned that is the primary of a number of deliberate FDA submissions for the corporate. It comes lower than a 12 months after Alio wrapped up a $20 million Sequence B funding spherical. 

“Alio is pushed by innovation. For the reason that founding of Alio, we now have at all times recognized that distant affected person monitoring with Alio can enhance affected person outcomes and improve the probability of a greater high quality of life at a decrease value to the healthcare system,” CEO David Kuraguntla mentioned in an announcement. “We’re thrilled to have reached this vital milestone as an organization, it really makes our imaginative and prescient really feel even nearer to actuality.”


Although Alio mentioned it’s engaged on medical research to validate the system’s use for different indications, its present focus is distant monitoring for end-stage kidney illness, the place the kidneys now not operate sufficiently on their very own and require dialysis or a transplant.

In accordance with the United States Renal Knowledge System 2020 Annual Knowledge Report, practically 786,000 individuals within the nation have end-stage kidney illness, which might significantly restrict lifespan. It is also a pricey situation to handle; whole Medicare fee-for-service spending for sufferers with end-stage kidney illness reached $37.3 billion in 2019, making up about 7% of the Medicare paid claims prices.


There are a selection of rivals within the distant affected person monitoring house. Athelas, which gives a number of distant monitoring instruments together with its flagship blood diagnostics gadget, scored $132 million throughout two funding rounds, bumping its valuation to $1.5 billion. 

VitalConnect, maker of biosensors for in-hospital and distant affected person monitoring, introduced it had raised $39 million in Sequence E funding earlier this 12 months. In the meantime, Cadence, which focuses on power situation administration, raised $100 million in December. 

Retail big Greatest Purchase has additionally been transferring deeper into distant monitoring and delivering healthcare at dwelling with its current acquisition of Present Well being. Final month, Present revealed new options for its platform that goals to assist suppliers handle long-term well being situations like hypertension, bronchial asthma, COPD, CHF and diabetes.

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