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

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

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 info, 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 yr after Alio wrapped up a $20 million Series B funding spherical. 

“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,” CEO David Kuraguntla mentioned in an announcement. “We are thrilled to have reached this important milestone as a company, it truly makes our vision feel even closer to reality.”


Though Alio mentioned it’s engaged on scientific 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 not operate sufficiently on their very own and require dialysis or a transplant.

According to the United States Renal Data System 2020 Annual Data Report, practically 786,000 folks within the nation have end-stage kidney illness, which might critically restrict lifespan. It’s additionally a expensive situation to handle; complete 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 quite a lot of opponents within the distant affected person monitoring area. Athelas, which affords 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 Series E funding earlier this yr. Meanwhile, Cadence, which focuses on continual situation administration, raised $100 million in December. 

Retail big Best Buy has additionally been shifting deeper into distant monitoring and delivering healthcare at dwelling with its latest acquisition of Current Health. Last month, Current 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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