This is the second FDA clearance in two weeks for Massachusetts-based Anumana. The company's AI models are built to evaluate ECG results for signs of various cardiovascular conditions.
In October, Harrison.ai submitted a citizen petition seeking greater flexibility in the 520(k) clearance process for certain computer-aided detection devices.
TTVR has made a major impact on heart patients all over the world. Just like aortic and mitral valve replacement, however, paravalvular leak is a serious complication that can lead to much worse outcomes.
Melissa Davis, MD, vice chair of medical informatics and associate professor at Yale University’s Department of Radiology and Biomedical Imaging, shares her findings from research on private equity market penetration.
Systole Health is focused on providing personalized healthcare to women with heart disease. “As a cardiologist, I have witnessed firsthand the struggles women face in managing their heart health," the company's co-founder said.