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FDA Cautions Consumers Against Use of RoyalVibe Ultrasound Devices

Vesta Teleradiology

Food and Drug Administration issued a warning to consumers on July 17 about avoiding the use of ultrasound devices from a Texas-based manufacturer and distributor called RoyalVibe Health. However, the FDA has not reviewed these devices, and they lack the necessary 510(k) clearance or premarket approval. What is 510(k) Clearance?

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GE HealthCare to Spotlight Industry-Leading AI-Enabled Portfolio and Digital Solutions at HIMSS 2024

Imaging Technology

milla1cf Thu, 03/07/2024 - 20:10 March 7, 2024 — GE HealthCare will showcase its industry-leading portfolio of artificial intelligence ( AI )-enabled medical devices and digital solutions in Booth 2500 at the Health Information and Management Systems Society ( HIMSS ) Global Health Conference and Exhibition in Orlando, FL from March 11-15, 2024.