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.
Radiology researchers have developed and validated an automated program for tracking incidental imaging findings. The system facilitates communications between radiologists, patients and primary care providers whenever such findings turn up.
A federal judge also halted the order, which instructed federal agencies to “temporarily pause all activities related to obligation or disbursement of all federal financial assistance."
