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.
Endotracheal tubes inside Medline neonatal intubation kits have been deemed too narrow, putting newborn patients at risk for hypoxia. This recall has been given the most serious FDA designation due to the risk of death.
Law firm Wright & Schulte said they filed a legal complaint on behalf of patients, pointing to the health system’s alleged lack of transparency and negligence in protecting data as the basis for the lawsuit.
Janet Wei, MD, examined the key differences between men and women when it comes to cardiovascular disease. These differences, she said, highlight why female patients need their very own treatment guidelines.
The San Diego-based startup gained FDA approval for its Hotwire RF guidewire in 2024. The technology has already been used to perform hundreds of heart procedures.
