Tag: FDA clearance

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The system uses real-time data to support clinical decision-making and includes an FDA-cleared application for monitoring surgical instruments.

The new technology is designed to improve oxygen saturation monitoring reliability across diverse skin tones and patient populations.

The system uses artificial intelligence to provide real-time guidance for brain biopsies, shunt placements, and other neurosurgical procedures.

The system uses real-time data to support clinical decision-making and includes an FDA-cleared application for monitoring surgical instruments.

Apr 9, 2026

The wearable sensor system provides continuous, simultaneous monitoring of maternal and fetal vital signs to improve clinical evaluation.

Apr 2, 2026

The software is designed to enhance spatial resolution and suppress artifacts in pulmonary, musculoskeletal, and inner ear scans.

Mar 31, 2026

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

Mar 31, 2026

The platform combines planning, navigation, and robotics, with AI-enabled features for imaging and workflow support.

Mar 31, 2026

Device is designed to regulate irrigation and intrarenal pressure during endoscopic urologic procedures

Mar 27, 2026

EchoNavigator with DeviceGuide uses AI to track and visualize repair devices in real time during minimally invasive procedures.

The extremity-focused system is designed for point-of-care use, including clinics and ambulatory settings.