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.

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Philips Gains FDA 510(k) Clearance for Elevate Plus Ultrasound AI

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 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

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?

SKIA HEAD: AR Surgical Guidance Receives FDA 510(k) Clearance, Eyes U.S. Expansion with Structure Partnership

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.