FDA Status
October
05
2023
{post_date: F d, Y}
Anumana earns first full FDA clearance for AI to detect low ejection fraction
Fierce Biotech: Two years after its launch as a joint venture between the Mayo Clinic and Nference to develop artificial intelligence algorithms capable of pulling out new insights from routine…
October
03
2023
{post_date: F d, Y}
Anumana wins FDA clearance for ECG-AI algorithm
Mass Device: Anumana announced that it received FDA 510(k) clearance for its AI-powered ECG-AI LEF medical device.
October
02
2023
{post_date: F d, Y}
AI-powered device to identify low LV ejection fraction gains FDA 510(k) clearance
Healio: An AI-powered device to identify low left ventricular ejection fraction in patients at risk for HF gained 510(k) clearance from the FDA.
June
22
2023
{post_date: F d, Y}
FDA grants breakthrough designation for Anumana’s ECG-AI algorithm
Medical Device Network: The US Food and Drug Administration (FDA) has granted breakthrough device designation (BDD) for the electrocardiogram-artificial intelligence (ECG-AI) algorithm by AI-driven health technology company Anumana. The algorithm…
June
22
2023
{post_date: F d, Y}
Anumana’s Pfizer-backed cardiac amyloidosis-spotting AI algorithm nabs FDA breakthrough tag
Fierce Biotech: For the fourth time in half as many years, Anumana has earned the FDA’s breakthrough device designation for another of its artificial intelligence algorithms designed to catch hard-to-spot…
June
21
2023
{post_date: F d, Y}
Anumana’s AI algorithm for cardiac amyloidosis gets FDA breakthrough nod
Bioworld: Anumana Inc. has garnered a U.S. FDA breakthrough device designation for its artificial intelligence (AI)-powered electrocardiogram-based algorithm for early identification of cardiac amyloidosis. The ECG-AI detection algorithm is the…
June
21
2023
{post_date: F d, Y}
FDA grants breakthrough designation for new AI model to detect cardiac amyloidosis in ECG results
Cardiovascular Business: Anumana, a Massachusetts-based healthcare technology company focused on artificial intelligence (AI), has received a breakthrough device designation from the U.S. Food and Drug Administration (FDA) for a new…
June
21
2023
{post_date: F d, Y}
Anumana Receives U.S. FDA Breakthrough Device Designation for its Cardiac Amyloidosis Algorithm
DAIC: Anumana, Inc., a leading AI-driven health technology company, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its ECG-AI algorithm designed to aid the…
June
21
2023
{post_date: F d, Y}
AI algorithm for detection of cardiac amyloidosis gains FDA breakthrough device status
Healio: Anumana announced it received FDA breakthrough device designation for its artificial intelligence-guided ECG algorithm for the early identification of cardiac amyloidosis.
May
26
2022
{post_date: F d, Y}
Way of Diagnosing PH in Common Heart Test Gets FDA Support
Pulmonary Hypertension News: Anumana’s electrocardiogram (ECG)-based algorithm for the early detection of pulmonary hypertension (PH) has been designated a breakthrough device by the U.S. Food and Drug Administration (FDA). The…