AI for detection of diastolic dysfunction gains FDA breakthrough device designation
Key takeaways:
- An AI algorithm for detection of grade 3 diastolic dysfunction received a breakthrough device designation from the FDA.
- Diastolic dysfunction is an early predictor of HF with preserved ejection fraction.
Carelog announced its ECG-based algorithm received FDA breakthrough device designation for detection of diastolic dysfunction, an early predictor of HF with preserved ejection fraction.
The breakthrough device designation is intended to expedite the development and review of devices intended to treat a serious condition in which preliminary clinical evidence indicates potentially substantial improvement over available devices.
The non-invasive ECG algorithm (Diastolytix) is designed to use machine learning to analyze ECG data and identify grade 3 diastolic dysfunction, according to a company press release.
“I’m thrilled to announce that Carelog has received FDA Breakthrough Device Designation for our innovative ECG algorithm that detects diastolic dysfunction — an often underdiagnosed precursor to HFpEF,” Aman Alok, founder and CEO of Carelog, said in the release. “Early detection is critical, as HFpEF patients face significant challenges: Current treatment options are limited, mostly pharmaceutical, and the 5-year survival rate for these patients can range from 40% to 60%.”
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