FDA clears Eko Health hybrid AI stethoscope and RIVANNA software

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearances to several medical diagnostic technologies. Eko Health has received approval for its CORE 300 stethoscope, designed for both pediatric and adult patients. The device is the first to combine a traditional acoustic mode with a digital mode within a single chestpiece. Key features include up to 35 times sound amplification, active noise cancellation, a real-time heart rate display, and FDA-cleared artificial intelligence to identify structural heart murmurs.

RIVANNA has also obtained FDA clearance for BoneEnhance, a machine-learning-based software module for the Accuro XV diagnostic ultrasound system. This module is designed to segment bone structures and surrounding soft tissue to provide three-dimensional imaging capabilities.

Additionally, bioMérieux received authorization for a molecular rapid test capable of providing eight results from a single swab within 20 minutes.