AmplexDiagnostics has announced a CE-IVD molecular diagnostic technology combining LAMP amplification and CRISPR-based detection for potential European diagnostic applications.

The FDA has approved Edwards Lifesciences' Pascal Precision system for transcatheter repair of severe tricuspid regurgitation, expanding the device's use beyond mitral valve treatment.

Biodesix is collaborating with Vanderbilt University and Vanderbilt Health to develop an AI-enabled lung nodule risk assessment test combining imaging and blood-based biomarkers.

The FDA has cleared Masimo's smartSET-powered atrial fibrillation detection capability for the Radius VSM patient monitoring system, expanding its continuous monitoring functionality.

The FDA has cleared Stryker's Sonopet 3 ultrasonic surgical platform, introducing enhanced bone and soft-tissue removal capabilities for surgical procedures.

Medovate and JEB Technologies are combining into a single medical-device company under the Medovate name, integrating product development, manufacturing, regulatory and commercial capabilities.