GE HealthCare earns FDA nod for AI-enabled radiotherapy tech
June 4, 2026
GE HealthCare (Nasdaq:GEHC) announced today that it received FDA 510(k) clearance for its MIM Contour ProtégéAI+ 2.0 software.
GE HealthCare (Nasdaq:GEHC) announced today that it received FDA 510(k) clearance for its MIM Contour ProtégéAI+ 2.0 software.
Brain Navi Biotechnology Achieves Key Regulatory Milestone Following Recognition at the 22nd National Innovation Award
MILFORD, Mass., June 3, 2026 /PRNewswire/ — Waters Corporation (NYSE: WAT) today announced that the BD BACTEC FXI Culture System has received U.S. Food and Drug Administration (FDA) 510(k) clearance.
Clarius Mobile Health announced FDA clearance for its Ejection Fraction AI, an intelligent cardiac assessment tool integrated directly into the Clarius ultrasound app.
Philips (NYSE:PHG) announced today that it received FDA clearance for its Elevate Plus advanced imaging and AI and automation capabilities.
Pulmera announced today that it received FDA 510(k) clearance for its CBeam 3D intraoperative imaging platform.
Edwards Lifesciences (NYSE:EW) said today that it received FDA approval for Triformis Resilia, its surgical tricuspid valve replacement.
The development coincides with several steps by SHINE Technologies to broaden its position in nuclear medicine.
SEOUL, South Korea, May 29, 2026 /PRNewswire/ — South Korea-based medtech innovator SKIA has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its augmented reality (AR) surgical guidance system, SKIA HEAD.
Coredio’s AI software is used to monitor HF parameters via wearables and standard blood pressure cuffs.