FDA grants de novo approval for AI algorithm for detection of hypertrophic cardiomyopathy
Key takeaways:
- AI module for the detection of hypertrophic cardiomyopathy gains de vovo FDA approval.
- The module is integrated into the Viz.ai’s preexisting AI platform and mobile app notification system.
Viz.ai announced it has received de novo approval from the FDA for its artificial intelligence module for the early detection hypertrophic cardiomyopathy.
The module (Viz HCM), which is integrated into the company’s AI platform (Viz.ai), automatically reviews routine ECGs to identify suspected HCM and subsequently notifies the patient care team via mobile application (Viz), according to a company press release.
Clinicians can use the platform to review a patient’s ECG and coordinate follow-up with an echocardiogram for HCM diagnosis, according to the release.
“Given the high prevalence of patients with suspected HCM who remain undiagnosed, flagging and connecting them quickly to the right providers is critical to improve health outcomes,” Healio | Cardiology Today Editorial Board Member Matthew W. Martinez, MD, director of Atlantic Health System Sports Cardiology at Morristown Medical Center in New Jersey, said in the release. “The role of artificial intelligence in cardiology is growing exponentially and adding the HCM module to Viz.ai will help increase awareness and reach for HCM patients.”
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