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BioWorld - Tuesday, June 2, 2026
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Home » FDA OKs Edwards’ HPI software with noninvasive Acumen IQ cuff
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FDA OKs Edwards’ HPI software with noninvasive Acumen IQ cuff

June 2, 2021
By Meg Bryant
Edwards Lifesciences Corp. has won the FDA’s nod for its Acumen hypotension prediction index (HPI) software with the Acumen IQ finger cuff. Prior to receiving this 510(k) clearance, the low blood pressure prediction software was only available for patients using an invasive arterial line. The Acumen HPI software uses data gleaned from the Acumen IQ cuff, along with machine learning, to alert clinicians if a patient is at risk of hypotension, drops in pumping pressure that reduce the flow of oxygenated blood and nutrients to the body’s vital organs.
Briefs Medical technology Regulatory Monitoring Digital health Artificial intelligence Cardiovascular 510(k) FDA

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