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FDA clears 510(k) for Echo IQ’s aortic stenosis SaMD

Oct. 9, 2024

The U.S. FDA gave the 510(k) green light to Echo IQ Ltd.’s Echosolv AS for its AI-enabled software as a medical device to be used as a decision support aid in detecting severe aortic stenosis.

Medical technology Regulatory Digital health Artificial intelligence Cardiovascular Asia-Pacific Australia U.S. FDA

Today's news in brief

BioWorld

BioWorld briefs for Feb. 3, 2025.

Today's news in brief

Briefs

BioWorld MedTech briefs for Jan. 30, 2026.

Centessa’s CNT-9982 shows promise for MDD

BioWorld Science

Orexin OX2 receptor agonists have demonstrated the ability to enhance wakefulness in rodent models, as well as in nonhuman primates and patients with narcolepsy...

First-in-class ADC targeting DEM-TXX shows high preclinical efficacy

BioWorld Science

Researchers at DEM Biopharma Inc. reported preclinical findings demonstrating the efficacy of DEM-301, a bifunctional antibody-drug conjugate (ADC) engineered to...

Illustration of brain with neuron receptor

5-HT2R allosteric ligands attenuate cocaine use and seeking behavior

BioWorld Science

Serotonergic G-protein-coupled receptors (GPCRs), including the 5-HT2A receptor (5-HT2AR) and 5-HT2CR, are key regulators of cortical signaling pathways and...