Philips Gains FDA 510(k) Clearance for Elevate Plus Ultrasound AI
AI meets ultrasound: Philips’ Elevate Plus automates workflows on Epiq Elite and Affiniti — faster scans, fewer errors.
Penumbra’s THUNDERBOLT Receives FDA Clearance — Bringing Computer Assisted Vacuum Thrombectomy Technology to Stroke
Penumbra’s THUNDERBOLT uses AI to modulate suction — faster, smarter clot removal for stroke patients.
X-Ray AI Software Gets Expanded FDA Clearance for Detecting Joint Effusions and Dislocations
AI now spots joint effusions and dislocations with 97%+ accuracy. Could this be the future of trauma radiology triage?
Bayesian Health Receives First-Ever FDA Clearance for Continuous AI Sepsis Monitoring
First-ever continuous AI sepsis monitor gets FDA nod—could revolutionize ICU surveillance and early intervention for critical patients.
SKIA HEAD: AR Surgical Guidance Receives FDA 510(k) Clearance, Eyes U.S. Expansion with Structure Partnership
SKIA’s AR platform overlays 3D reconstructions onto patients in real-time—could revolutionize image-guided surgery and IR procedures.
Jupiter Endovascular Announces Positive Results From SPIRARE II Pivotal Trial at EuroPCR 2026
SPIRARE II trial shows Jupiter’s Vertex system delivers rapid right heart recovery in PE patients—could redefine thrombectomy standards.
Siemens Healthineers scores FDA clearance for 6 interventional systems
Six new Siemens IR systems cleared with AI that slashes radiation dose while preserving image quality—game-changer for patient safety.
Medtronic seeks FDA clearance for Hugo RAS system
Medtronic pushes Hugo RAS into general and gynecologic surgery—could reshape robotic access for IR-adjacent specialties if cleared.
GE HealthCare receives FDA 510(k) clearance for MIM Contour ProtégéAI+ 2.0
GE’s latest AI contouring software gains FDA nod—boosting precision and speed in radiation oncology planning for complex tumors.