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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.

BioWorld MedTech Regulatory Artificial intelligence Cardiovascular Digital health Asia-Pacific Australia U.S. FDA

Today's news in brief

BioWorld

BioWorld briefs for Dec. 24, 2025.

Today's news in brief

BioWorld MedTech

BioWorld MedTech briefs for Dec. 24, 2025.

Illustration of magnifying glass looking at cancer in the brain

Researchers discover how glioblastoma tumors dodge chemotherapy

BioWorld MedTech

Researchers at the University of Sydney have uncovered a mechanism that may explain why glioblastoma returns after treatment, and the world-first discovery offers...

Shionogi nabs revenue-generating ALS drugs with $2.5B Tanabe pact

BioWorld

Shionogi & Co. Ltd. will acquire global rights to U.S. FDA approved amyotrophic lateral sclerosis therapy edaravone through a $2.5 billion acquisition deal with...

Illustration of tau accumulating in a neuron cell.

ADEL wins $1.04B Sanofi deal for tau-targeting Alzheimer’s drug

BioWorld

ADEL Inc. closed a year-end licensing deal worth up to $1.04 billion with Sanofi SA for ADEL-Y01, a specific tau-targeting Alzheimer’s disease drug candidate in a...