🫀 Echocardiograms are vital tools in heart disease diagnosis, but the shortage of trained cardiac sonographers limits their accessibility.
🌟 Enter Caption Health (now part of GE HealthCare), an organization on a mission to transform cardiac care through the power of AI and ultrasound.
🔍 Caption Health engaged with the FDA early on, leveraging options like pre-submission meetings and applying for breakthrough designation status. Their diligence paid off as they obtained the first regulatory approval for a predetermined change control plan (PCCP). This allowed them to optimize their software without additional regulatory submissions, saving valuable time and resources.
🏅 Since embarking on this journey, Caption Health received the first FDA-authorized cardiac ultrasound AI software clearance! This groundbreaking achievement paved the way for broader access to cardiac care and opened reimbursement pathways, enabling Caption Health to obtain a new technology add-on payment (NTAP) designation.
📄 Read the case study here: https://bit.ly/3VasKJi
Associate VP Regulatory Affairs & Quality at Nanox AI (Previously Zebra Medical Vision)
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