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 diffusion MRI software helps differentiate between Parkinson’s disease, atypical parkinsonism, multiple system atrophy Parkinsonian variant and progressive supranuclear palsy.
The Adams Valve Institute—named after David H. Adams, MD—plans on uniting specialists to provide high-quality care, promote innovation and advocate for policy reform.
A majority of deaths from Friedreich's ataxia are associated with heart complications. A new treatment years in the making could provide some much-needed relief.
