The US Food and Drug Administration’s approval of hypertrophic cardiomyopathy for Viz.ai establishes a new category for cardiovascular machine learning-based notification software.
why does it matter
Viz.ai, a company that specializes in disease detection and intelligent care coordination, said in its announcement Tuesday that with ML scan images across a health system, more patients with suspected HCM can be identified and diagnosed earlier.
“Hypertrophic cardiomyopathy is a devastating disease that often goes undetected until it is too late,” said Dr. Chris Mansi, CEO and Co-Founder of Viz.ai, in the release.
According to the company’s website, 1 million people in the United States have HCM, but only 20% of them have been diagnosed. While this is the leading cause of sudden cardiac death in people under the age of 35, early detection and treatment can lead to normal longevity and quality of life.
With a platform that detects non-obstructive and obstructive HCM, providers can move their patients to the appropriate cardiologist faster. After it receives the HCM alert, the appropriate care team can review the patient’s ECG, coordinate follow-up with the echocardiogram and access images and reports on the Viz mobile app.
The HCM artificial intelligence is one of twelve algorithms approved by the FDA on the San Francisco-based company’s enterprise-level AI platform.
Visay noted that deployment of the algorithm, which was developed with more than 830,000 ECG tests from 300,000 individuals across multiple global locations, is financially supported by a multi-year agreement with Bristol Myers Squibb.
The biggest trend
Over the past five years, the FDA has advanced its approach to regulating and approving AI-enabled devices — with a De Novo pathway intended to be a good fit for low-to-moderate-risk devices to obtain marketing authorization, as is the case with the FDA Commissioner. American d. In 2019. Just last month, Gottlieb said Scott Gottlieb Editorial books explaining how “artificial intelligence may take over the roles of physicians sooner rather than later”.
Hypertrophic cardiomyopathy severely affects young people who inherit it. Reggie Lewis and other famous young athletes unexpectedly experienced cardiac arrest from undiagnosed HCM.
Last year, Cedars-Sinai also created an AI tool to help identify hypertrophic cardiomyopathy and cardiac amyloidosis.
“Our AI algorithm can identify disease patterns that cannot be seen with the naked eye, and then use these patterns to predict the correct diagnosis,” said Dr. David Ouyang, a cardiologist at the Smidt Heart Institute, in a statement about his study. Published in heart gamma.
At the time, these researchers acknowledged a possible bias in the available training images.
For example, although hereditary cardiac amyloidosis is known to disproportionately affect black individuals in the United States, they are underrepresented in study cohorts, and care must be taken to extrapolate the performance of deep learning algorithms in populations with different demographic characteristics, as they say.
However, AI is believed to be a promising method for improving heart disease care.
In the previous year, researchers at the Mayo Clinic looked at how AI could detect heart failure and, more specifically, a decreased ejection fraction — a measure of the blood the left ventricle pumps out with each contraction — which is a sign of heart failure.
“In absolute terms, for every 1,000 patients screened, AI screening resulted in five fewer new ejection fraction diagnoses than usual care,” said Xiaoxi Yao, a health outcome researcher in cardiovascular disease at the Mayo Clinic, in a statement.
On the record
“Given the high prevalence of patients with suspected HCM who are not yet diagnosed, promptly reporting and connecting them to appropriate providers is critical to improving health outcomes,” said Dr. Matthew Martinez, director of sports cardiology and HCM for Atlantic Health in Phis. ad.ai. “The role of artificial intelligence in cardiology is growing exponentially and the addition of the HCM module to Viz.ai will help increase awareness and reach for HCM patients.”
Andrea Fox is Senior Editor, Healthcare News for IT.
Email: afox@himss.org
Healthcare IT News is a publication of HIMSS Media.