Clearances

FDA Clears New Contrast Management System for Cardiovascular Procedures

The ACIST Pro Diagnostic System provides automated contrast delivery to improve efficiency and safety in cardiac catheterization labs.

Clearances

FDA Clears Avatar Medical Vision for 3D Imaging and Surgical Planning

The software supports CT and MR image visualization across standard displays, glasses-free 3D systems, and virtual reality environments.

Clearances

Restore Robotics Receives FDA Clearance for Additional Remanufactured da Vinci Xi Instruments

Clearances expand options for hospitals seeking lower-cost alternatives to OEM robotic surgical instruments.

Clearances

FDA Clears New Contrast Management System for Cardiovascular Procedures

The ACIST Pro Diagnostic System provides automated contrast delivery to improve efficiency and safety in cardiac catheterization labs.

FDA Clears GE HealthCare’s MIM LesionID Pro for Automated Tumor Burden Analysis

Mar 4, 2026

The AI-enabled software automates whole-body tumor burden analysis for PSMA PET/CT and SPECT/CT studies to help clinicians assess treatment eligibility and monitor response.

FDA Clears Platform for Noninvasive Cardiac Conduction System Visualization

Mar 4, 2026

The CTA-based system creates a patient-specific 3D map of the cardiac conduction system to support planning and guidance during procedures such as TAVR and conduction system pacing.

FDA Clears Single-Use Articulating Laparoscope for Minimally Invasive Surgery

Feb 27, 2026

The 5mm Saberscope features a 90-degree articulating tip and integrated camera designed to reduce fogging and eliminate reprocessing needs.

GE HealthCare Receives FDA Clearance for Three New MRI Systems

Feb 19, 2026

The SIGNA portfolio includes a helium-free 1.5T system, advanced 3T scanner, and AI-driven workflow platform designed to improve imaging efficiency.

FDA Clears Cardiovascular Monitoring Software for Surgical and ICU Settings

Feb 17, 2026

Argos Infinity analyzes existing physiologic data streams to provide early detection of hemodynamic instability without requiring new bedside hardware.