EchoNous Secures FDA Clearance for Hand-Held Ultrasound Scanner

Eight-ounce scanner assesses heart function.

The U.S. Food & Drug Administration (FDA) has awarded 510(k) clearance to the hand-held ultrasound platform Kosmos, produced by the developer EchoNous.

By using machine learning, Kosmos can imitate humans’ learning and decision-making processes, according to the company. The 8-oz ultrasound tool has embedded and synchronized ECG and digital auscultation. Currently, the tool measures systolic heart function.

In addition, EchoNous has side-stepped the need for cloud connectivity with the Kosmos Bridge, a tablet that accompanies the platform. All artificial intelligence functions run on the tablet, ensuring there are no service failures during scans, EchoNous officials said. It is also designed to connect with a health system's IT system without a need for internet connectivity.

According to EchoNous officials, the Kosmos platform has been tested with more than 300 patients in acute care settings in the United States, Canada, Europe, and Japan. It will be available in the U.S. market for less than $10,000.

As a next step, company officials said, EchoNous plans to file for FDA clearance for a trio of algorithms that will allow users use machine learning algorithms to grade image quality, guide their technique, and label heart anatomy.