GE HealthCare secures FDA clearance and CE mark for deep learning tech

GE HealthCare secures FDA clearance and CE mark for deep learning tech

GE HealthCare announced the FDA submission at the Radiological Society of North America’s (RSNA) 2024 meeting…

Continue Reading
GE HealthCare Stock May Gain as FDA Approves Optison for Pediatric Use

GE HealthCare Stock May Gain as FDA Approves Optison for Pediatric Use

GE HealthCare Technologies Inc. GEHC recently announced FDA approval for Optison, its polyethylene glycol (PEG)-free ultrasound…

Continue Reading
GE HealthCare Receives FDA Clearance for Aurora and Clarify DL

GE HealthCare Receives FDA Clearance for Aurora and Clarify DL

May 5, 2025 — GE HealthCare recently announced that the U.S. Food and Drug Administration (FDA)…

Continue Reading
Trump administration FDA cuts hit new staff who review medical devices, food safety

Trump administration FDA cuts hit new staff who review medical devices, food safety

By Matthew PerroneAP Health Writer WASHINGTON — The Trump administration’s effort to slash the size of…

Continue Reading
FDA grants 510(k) to GE HealthCare’s updated ultrasound systems

FDA grants 510(k) to GE HealthCare’s updated ultrasound systems

The systems claim to support early identification, intervention, and diagnosis of complex and high-risk pregnancies. Credit:…

Continue Reading
Emergency Use Authorization | FDA

Emergency Use Authorization | FDA

Image Español About Emergency Use Authorizations (EUAs) The Emergency Use Authorization (EUA) authority allows FDA to…

Continue Reading