Two AI-powered ECG technologies cleared by FDA, launched
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Key takeaways:
- AliveCor announced the FDA clearance and launch of its AI for ECG interpretation and streamlined, handheld ECG system.
- The pocket-sized ECG system required minimal training and uses only a single cable.
AliveCor announced the FDA clearance and launch of its AI system designed to detect 35 cardiac conditions using a reduced leadset, in addition to its single-cable, AI-powered handheld ECG System.
The AI (KAI 12L) was trained and validated on more than 1.75 million ECGs and can detect 35 cardiac conditions, including 14 arrhythmias and 21 morphologies, and is designed to seamlessly integrate with compatible devices, including the company’s newly launched ECG System (Kardia 12L), according to a company press release.
The pocket-sized system is battery-operated, requires minimal self-guided training and uses a single cable with five electrodes to acquire eight diagnostic bandwidth leads, according to the release.
“The AI innovations in the Kardia 12L ECG System offer health care providers a clinically validated handheld 12-lead ECG system and expands this critical technology into more resource-limited settings,” Stavros Stavrakis, MD, PhD, professor of medicine, division of cardiology at the University of Oklahoma Health Sciences Center, said in the release. “By streamlining the process of recording a 12-lead ECG, Kardia 12L has significant implications for rapid ECG diagnosis in clinical practice.”
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