FDA Status
May
24
2022
May 24, 2022
FDA grants Breakthrough Device Designation to pulmonary hypertension early detection AI
Pharma File: Anumana has announced the FDA had granted breakthrough Device Designation to its AI-enhanced ECG-based Pulmonary Hypertension (PH) Early Detection Algorithm. Breakthrough Device Designations recognise novel innovations demonstrating potential…
May
24
2022
May 24, 2022
Anumana’s AI tool for pulmonary hypertension gets FDA breakthrough status
Medical Device Network: Anumana has received US Food and Drug Administration (FDA) Breakthrough Device Designation for its artificial intelligence (AI)-enhanced, electrocardiogram (ECG)-based Pulmonary Hypertension (PH) Early Detection Algorithm. The accurate,…
May
24
2022
May 24, 2022
Anumana wins FDA breakthrough status for AI algorithm to detect PH
NS Medical Devices: AI-driven health technology company Anumana has received breakthrough device designation from the US Food & Drug Administration (FDA) for its ECG-based Pulmonary Hypertension (PH) algorithm. The AI-enhanced…
May
23
2022
May 23, 2022
Anumana wins FDA breakthrough nod for AI algorithm that detects pulmonary hypertension
Mass Device: Anumana announced today that it received FDA breakthrough device designation for its pulmonary hypertension (PH) early detection algorithm. Cambridge, Massachusetts-based Anumana, formed by Mayo Clinic and nference and launched in…
May
23
2022
May 23, 2022
Anumana’s ECG Pulmonary Hypertension AI Algorithm Gains Breakthrough Status
Medical Product Outsourcing: Artificial intelligence (AI)-driven healthtech company, Anumana has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its AI-enhanced, ECG-based pulmonary hypertension (PH) early detection algorithm.…
May
23
2022
May 23, 2022
FDA Grants Breakthrough Device Designation to Anumana’s ECG Pulmonary Hypertension Early Detection AI Algorithm
DAIC: Anumana, Inc., an AI-driven health technology company from nference, Inc., today announced that the U.S. Food & Drug Administration (FDA) has granted Breakthrough Device Designation to itsAI-enhanced, ECG-basedPulmonary Hypertension(PH) Early…
May
23
2022
May 23, 2022
Mayo Clinic, Janssen-backed venture gets FDA OK for pulmonary hypertension AI algorithm
Becker's Hospital Review: A Mayo Clinic and Janssen-backed venture has received FDA breakthrough designation for an algorithm designed to enable early detection of pulmonary hypertension. Anumana Inc. received the breakthrough…