Sensydia reaches study target for its AI-powered heart analysis device
Noninvasive device may enable early detection of PH and heart failure
Sensydia has completed a development study to assess the effectiveness of its Cardiac Performance System (CPS) in identifying people at risk for pulmonary hypertension (PH) and heart failure.
CPS is a handheld, noninvasive device powered by artificial intelligence that uses heart sound analysis to detect PH.
The device’s ultra-sensitive biosensors can assess key parameters of cardiac performance in minutes, according to the company. These parameters include ejection fraction — or the percentage of blood pumped out of the heart when it contracts — cardiac output, which evaluates the amount of blood the heart pumps in one minute, and pulmonary artery pressure.
Standard tests to diagnose PH carry significant risks of complications
Data on these parameters is paramount for PH diagnosis and patient monitoring. Currently, these measurements are obtained using echocardiography, a scan of the heart, and invasive right heart catheterization, a procedure where a catheter is inserted into a vein in the neck, arm, or groin to measure the pressure in the pulmonary artery.
While this is the standard approach to diagnose PH, it carries significant risks of complications and is resource-intensive.
“Having access to accurate cardiac performance data for heart patients is critical for improving outcomes,” Samir Saba, MD, co-director of the Heart and Vascular Institute at the University of Pittsburgh Medical Center (UPMC), where the study was conducted, said in a press release.
With CPS, physicians can obtain fast and safe measurements of patients in a hospital or medical office, or even by telemedicine at home, according to Sensydia.
“This Cardiac Performance System (CPS) shows promise as a non-invasive alternative to right-heart catheterization,” said Saba, who also serves as chief of cardiology at UPMC. “The CPS platform has the potential to revolutionize the way we diagnose and treat heart failure and pulmonary hypertension by enabling rapid, non-invasive assessment of cardiac pressures.”
The study at UPMC enrolled 225 participants and started during the COVID-19 pandemic.
“When we began this study at UPMC during the height of the COVID-19 pandemic, our original enrollment target for the study was 110 subjects, but we ended up doubling that after hearing positive feedback from the UPMC study staff,” said Anthony Arnold, president and CEO of Sensydia.
The CPS platform has the potential to revolutionize the way we diagnose and treat heart failure and pulmonary hypertension by enabling rapid, non-invasive assessment of cardiac pressures.
Study results will help develop pulmonary pressure algorithms
The results will now help in furthering the development of CPS pulmonary pressure algorithms, according to Sensydia, which is closing a new round of funding.
“This is Sensydia’s fourth successful study and we will continue to collect data across multiple sites to improve the performance and utility of the artificial intelligence algorithms that power our breakthrough CPS platform,” said Anthony Arnold, president and CEO of Sensydia.
A prior study conducted at the Ronald Reagan UCLA Medical Center supported the clearance by the U.S. Food and Drug Administration (FDA) of the device’s ejection fraction algorithm. Its cardiac output algorithm was approved following a study at the Oregon Health & Science University Knight Cardiovascular Institute.
In January 2022, the FDA granted CPS its breakthrough device designation, which is given to accelerate the development and review of devices or device-led combination products that might more effectively treat or diagnose life-threatening or irreversibly debilitating diseases.
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