DESKi granted FDA clearance for cardiac AI software

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to DESKi for its HeartFocus AI-enabled cardiac exam software.

HeartFocus enables healthcare providers to perform diagnostic-grade echocardiograms from any compatible handheld, portable, or cart-based device, according to DESKi. The Bordeaux, France-based company said that its use requires only a few hours of training to use.

HeartFocus is available as an app or as a software development kit, according to the company. The HeartFocus app runs Al models to guide, detect, and capture the 10 ultrasound cardiac reference views in real time.

The FDA also approved DESKi’s Predetermined Change Control Plan (PCCP) for HeartFocus. This approval will expedite collaboration with other ultrasound systems, DESKi said.