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.
The modality uses a high volume of linens, gels and other disposable supplies that also can have a significant global carbon footprint in radiology, experts note.
The recall was put in place after a customer discovered “visible black particulate matter” in a sealed vial. If the contaminant enters a patient's blood vessels, it could lead to serious complications, including a stroke or even death.
A string of executive orders from the White House created serious concerns among radiologists and other healthcare providers throughout the United States. The American College of Radiology issued a statement to help guide its members through the chaos.
