The agency published its first action plan last week for how it plans to regulate machine learning-based software as a medical device. To start, the FDA said it will issue guidance on how changes to algorithms should be regulated as they “learn.”
What You Should Know: – Bill & Melinda Gates Foundation awards Caption Health a $4.5M grant to support the development of an AI-guided lung ultrasound system. – The grant from the Bill & Melinda Gates Foundation will be leveraged to create new AI technology that… Read More »Gates Foundation Awards Caption Health $4.95M Grant to Develop AI-Guided Lung Ultrasound System
What You Should Know: – Northwestern Memorial Hospital is the first in the nation to deploy FDA-cleared AI-guided ultrasound by Caption Health, including measurement of ejection fraction – the most widely used measurement to assess cardiac function. – Caption Health’s AI-guided cardiac ultrasound enables clinicians… Read More »Northwestern to Deploy FDA-Cleared Deploy AI-Guided Cardiac Ultrasounds
What You Should Know: – Caption Health AI is awarded FDA 510(k) clearance for its innovative point-of-care ejection fraction evaluation. – Latest AI ultrasound tool makes it even easier to automatically assess ejection fraction, a key indicator of cardiac function, at the bedside–including on the… Read More »Caption Health AI Awarded FDA Clearance for Point-of-Care Ejection Fraction Evaluation