Spotlight
Topics
DI Executive
Subscribe
- AI
- Molecular Imaging
- CT
- X-Ray
- Ultrasound
- MRI
- Facility Management
- Mammography
FDA Clears AI-Powered Ultrasound Software for Cardiac Amyloidosis Detection
The AI-enabled EchoGo® Amyloidosis software for echocardiography has reportedly demonstrated an 84.5 percent sensitivity rate for diagnosing cardiac amyloidosis in heart failure patients 65 years of age and older.
The Food and Drug Administration (FDA) has granted 510(k) clearance for the artificial intelligence (AI) software EchoGo® Amyloidosis, which may help bolster early detection of cardiac amyloidosis, a diagnosis that is commonly missed in high-risk patients with heart failure and preserved ejection fraction (HFpEF).
Requiring only a single apical four-chamber echocardiography video clip, the EchoGo Amyloidosis software facilitates improved accuracy in the detection of cardiac amyloidosis, according to Ultromics, the manufacturer of the software.
The newly FDA-cleared EchoGo Amyloidosis AI software has demonstrated 84.5 percent sensitivity for diagnosing cardiac amyloidosis in patients with heart failure that are 65 years of age and older, according to Ultromics, the developer of the software. (Image courtesy of Ultromics.)
Citing research submitted to the FDA, Ultromics noted that EchoGo Amyloidosis has 84.5 percent sensitivity and 89.7 percent specificity in diagnosing cardiac amyloidosis in patients with heart failure that are 65 years of age and older.
The company also pointed out that the AI software’s has demonstrated consistent sensitivity rates across different subtypes of amyloidosis such as AL (primary) amyloidosis (84.4 percent), hereditary transthyretin amyloidosis (TTRv) (86.3 percent), and wild-type transthyretin amyloidosis (85.8 percent).
“Improving the detection of cardiac amyloidosis is vital as early detection provides the greatest therapeutic benefit for patients. Novel AI-based diagnostic tools such as EchoGo® Amyloidosis from Ultromics should help facilitate disease identification, particularly in clinics and hospitals restricted by expertise and resource,” noted Sanjiv J. Shah, M.D., the director of the Heart Failure with Preserved Ejection Fraction (HFpEF) Program and the Center for Deep Phenotyping and Precision Medicine in the Institute for Augmented Intelligence in Medicine at the Northwestern University Feinberg School of Medicine.
Recent Videos
Related Content
Mammography Study Suggests DBT-Based AI May Help Reduce Disparities with Breast Cancer Screening
December 13th 2024Article
New research suggests that AI-powered assessment of digital breast tomosynthesis (DBT) for short-term breast cancer risk may help address racial disparities with detection and shortcomings of traditional mammography in women with dense breasts.
The Reading Room: Artificial Intelligence: What RSNA 2020 Offered, and What 2021 Could Bring
December 5th 2020Podcast
Nina Kottler, M.D., chief medical officer of AI at Radiology Partners, discusses, during RSNA 2020, what new developments the annual meeting provided about these technologies, sessions to access, and what to expect in the coming year.
Mammography News: FDA Grants Expanded 510(k) Clearance for AI-Powered SmartMammo Dx DBT Software
November 29th 2024Article
Originally cleared by the FDA in 2021, the SmartMammo Dx software for digital breast tomosynthesis (DBT) can now be utilized with the Senographe Pristina mammography systems from GE HealthCare.
