• Skip to main content
  • Skip to secondary menu
  • Skip to primary sidebar
  • Skip to secondary sidebar
  • Skip to footer

  • Opinion
  • Health IT
    • Behavioral Health
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Patient Engagement
    • Population Health Management
    • Revenue Cycle Management
    • Social Determinants of Health
  • Digital Health
    • AI
    • Blockchain
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • M&A
  • Value-based Care
    • Accountable Care (ACOs)
    • Medicare Advantage
  • Life Sciences
  • Research

AliveCor Receives “Breakthrough Device” Designation from FDA for Bloodless Hyperkalemia Test

by Fred Pennic 09/11/2018 Leave a Comment

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

AliveCor Receives “Breakthrough Device” Designation from FDA for Bloodless Hyperkalemia Test

AliveCor, a Mountain View, CA-based digital health  startup developing solutions to transform cardiac care, announced on Monday received “breakthrough device” designation from the U.S. Food and Drug Administration for their bloodless hyperkalemia test. Developed with Mayo Clinic, AliveCor’s KardiaK Platform screens for elevated levels of blood potassium – hyperkalemia, without requiring any blood from the patient.

This designation signals that the FDA will consider the technology on an accelerated clearance track designed specifically for medical devices that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions.

Blood potassium is tightly regulated in the body and can cause life-threatening cardiac arrhythmias and death when potassium levels increase even to mildly elevated levels. For the nearly 30 million US adults with chronic kidney disease, the one-day likelihood of death is nearly 3 times higher if a home potassium is 5.5 to 5.9 mmol/L, and over 13 times higher if it is 6.0 mmol/L or greater. For the 500,000 Americans with end-stage kidney disease and on dialysis, hyperkalemia may contribute up to 40% of deaths.

Utilizing a proprietary deep neural network trained to detect hyperkalemia using data from electrocardiograms (ECG) similar to those captured by AliveCor’s KardiaMobile and KardiaBand devices. AliveCor aims to use the platform to enable home-based hyperkalemia detection for patients with kidney disease, as well others at risk for this life-threatening condition.

Although treatments for hyperkalemia are effective and readily available – including the recently FDA-approved potassium binder medications patiromer and zirconium cyclosilicate – diagnosis of hyperkalemia, particularly outside of the hospital, can be a challenge as symptoms may be vague or absent. The gold standard for measuring potassium levels is a blood test, but the test is invasive and since it’s performed in a laboratory, inconvenient for patients. AliveCor aims to enable patients with kidney disease to record an ECG and use KardiaK at home. Noninvasive and convenient, the bloodless KardiaK platform has the potential to revolutionize the standard for diagnosis of hyperkalemia.

“This test, which performed extremely well in our evaluation using millions of ECGs, holds the promise of enabling people to painlessly determine whether a life-threatening and otherwise silent and very treatable condition is present – from the comfort of their own homes and within seconds,” noted Paul Friedman, MD, Chair of the Department of Cardiovascular Medicine and a member of the Mayo Clinic team that co-developed the test.  “It may save people’s lives, and save the health care system dollars.”

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

Tagged With: AliveCor, Cardiac Devices, Cardiac Monitoring, EKG Medical Devices, hyperkalemia, KardiaBand, Medical Devices

Tap Native

Get in-depth healthcare technology analysis and commentary delivered straight to your email weekly

Reader Interactions

Primary Sidebar

Subscribe to HIT Consultant

Latest insightful articles delivered straight to your inbox weekly.

Submit a Tip or Pitch

Featured Insights

2025 EMR Software Pricing Guide

2025 EMR Software Pricing Guide

Featured Interview

Paradigm Shift in Diabetes Care with Studio Clinics: Q&A with Reach7 Founder Chun Yong

Most-Read

Medtronic to Separate Diabetes Business into New Standalone Company

Medtronic to Separate Diabetes Business into New Standalone Company

White House, IBM Partner to Fight COVID-19 Using Supercomputers

HHS Sets Pricing Targets for Trump’s EO on Most-Favored-Nation Drug Pricing

23andMe to Mine Genetic Data for Drug Discovery

Regeneron to Acquire Key 23andMe Assets for $256M, Pledges Continuity of Consumer Genome Services

CureIS Healthcare Sues Epic: Alleges Anti-Competitive Practices & Trade Secret Theft

The Evolving Role of Physician Advisors: Bridging the Gap Between Clinicians and Administrators

The Evolving Physician Advisor: From UM to Value-Based Care & AI

UnitedHealth Group Names Stephen Hemsley CEO as Andrew Witty Steps Down

UnitedHealth CEO Andrew Witty Steps Down, Stephen Hemsley Returns as CEO

Omada Health Files for IPO

Omada Health Files for IPO

Blue Cross Blue Shield of Massachusetts Launches "CloseKnit" Virtual-First Primary Care Option

Blue Cross Blue Shield of Massachusetts Launches “CloseKnit” Virtual-First Primary Care Option

Osteoboost Launches First FDA-Cleared Prescription Wearable Nationwide to Combat Low Bone Density

Osteoboost Launches First FDA-Cleared Prescription Wearable Nationwide to Combat Low Bone Density

2019 MedTech Breakthrough Award Category Winners Announced

MedTech Breakthrough Announces 2025 MedTech Breakthrough Award Winners

Secondary Sidebar

Footer

Company

  • About Us
  • Advertise with Us
  • Reprints and Permissions
  • Submit An Op-Ed
  • Contact
  • Subscribe

Editorial Coverage

  • Opinion
  • Health IT
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Population Health Management
    • Revenue Cycle Management
  • Digital Health
    • Artificial Intelligence
    • Blockchain Tech
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • Value-Based Care
    • Accountable Care
    • Medicare Advantage

Connect

Subscribe to HIT Consultant Media

Latest insightful articles delivered straight to your inbox weekly

Copyright © 2025. HIT Consultant Media. All Rights Reserved. Privacy Policy |