GlobalData on MSN16d
AccurKardia’s AK+ Guard gains FDA breakthrough device status
AccurKardia has gained the US Food and Drug Administration's (FDA) breakthrough device designation for its AI-powered ‘AK+ Guard’ software, aimed at identifying hyperkalaemia, a condition that can ...
MassDevice17d
AccurKardia wins FDA breakthrough nod for hyperkalemia detection software
AccurKardia announced that it received FDA breakthrough device designation for its ECG-based, AI-powered hyperkalemia ...
Joplin Globe17d
AccurKardia Receives FDA Breakthrough Device Designation for AI-powered Hyperkalemia Detection Solution Using Lead I ECG Data
AccurKardia, an innovator in ECG-based diagnostics technology, has announced that it has received Breakthrough Device ...
Business Wire17d
AccurKardia Receives FDA Breakthrough Device Designation for AI-powered Hyperkalemia Detection Solution Using Lead I ECG Data
NEW YORK--(BUSINESS WIRE)--AccurKardia, an innovator in ECG-based diagnostics technology, has announced that it has received Breakthrough Device Designation by the U.S. Food and Drug ...
Morningstar17d
AccurKardia Receives FDA Breakthrough Device Designation for AI-powered Hyperkalemia Detection Solution Using Lead I ECG Data
AccurKardia's AK+ Guard is designed to work with a wide range of FDA-cleared consumer and clinical wearables that currently capture Lead I ECG data (e.g., smartwatches), enabling hyperkalemia ...