FDA OKs Edwards' AI, finger sensor combo to predict dangerously low blood pressures

Blood pressure monitors have already gone “smart,” with apps, smartwatches and other sleek wearables now able to take readings at least as accurate as traditional upper arm cuffs—if not more so. Now, Edwards Lifesciences is looking to bring ICU-quality blood pressure monitors into the future, too, with a noninvasive upgrade to the usual arterial catheter.

The device maker has already developed software to predict when a patient is at risk of hypotension, drops in blood pressure that can lead to severe heart and kidney issues or even death. The Acumen Hypotension Predictive Index tool uses machine learning to grade a patient’s likelihood of developing the condition, updating the score every 20 seconds and issuing alerts when the score repeatedly exceeds a certain level.

The Acumen HPI algorithm was trained on more than 200,000 hypotensive and non-hypotensive events and has been proven in clinical studies of surgical patients to have a positive predictive value of at least 98%.

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But while the Acumen HPI software was originally designed only to analyze blood pressure readings from invasive arterial lines, Edwards has now received FDA clearance to pair the software with its Acumen IQ finger cuff.

The finger cuff’s clearance offers a noninvasive way to take continuous and highly accurate blood pressure readings in critical care patients. It can also automatically calculate mean arterial pressure and cardiac output in real time.

The Acumen IQ device will “help clinicians make informed decisions for their patients, with the goals of reducing complications and helping patients with a quicker return to their families and their daily lives,” Katie Szyman, Edwards’ corporate vice president of critical care, said in a release.

“This latest predictive technology demonstrates our commitment to patient care and providing clinicians with ‘smart’ monitoring tools that allow for better prediction and management,” Szyman continued.

Edwards will begin the commercial rollout of the Acumen IQ finger cuff and HPI software pairing in the next few weeks, with the combo available on its HemoSphere advanced monitoring platform.

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That rollout will build on Edwards’ successful start to the year in its critical care business. In a financial report for the first quarter of 2021, the company reported better-than-expected sales growth across the board, including in critical care, as operating rooms and ICUs have resumed normal technology purchases amid the waning COVID-19 pandemic.

Sales in the sector hit $196 million for the quarter, up 7% from the same period last year. Specifically, orders of Edwards’ HemoSphere monitoring system increased and demand for its ClearSight noninvasive finger cuff nearly reached pre-COVID levels.