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Exo® Launches FDA-Cleared AI on Exo Iris™ to Address Heart Failure

Exo®, a medical imaging software and devices company, announced its FDA-cleared cardiac and lungartificial intelligence (AI) applications are now available on Exo Iris™, Exo’s...

Healthcare

Epitel Receives FDA 510(k) Clearance for Two New Technologies: REMI Remote EEG Monitoring System for Ambulatory Use and REMI Vigilenz AI For Event Detection

Advancements help neurologists detect and analyze suspected seizure events from patients in home healthcare settings for extended periods of time Epitel, a leader in AI...

Healthcare

FDA Approves Genentech’s Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung Cancer

This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant...

Healthcare

Roche granted FDA Breakthrough Device Designation for blood test to support earlier Alzheimer’s disease diagnosis

Roche announced that its Elecsys pTau217 assay received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This blood test, which is...

Healthcare

Intelligencia AI Awarded U.S. Patent for Its Accurate and Transparent Probability of Drug Success Assessments

Intelligencia AI, a provider of AI-powered solutions that support data-driven decision-making in drug development, announced that the U.S. Patent and Trademark Office (USPTO) issued...

Healthcare

Otsuka and Click Therapeutics Announce the U.S. Food and Drug Administration (FDA) Clearance of Rejoyn™, the First Prescription Digital Therapeutic Authorized for the Adjunctive...

Otsuka Pharmaceutical, Co. Ltd. and Click Therapeutics, Inc., announce that the U.S. Food and Drug Administration (FDA) has cleared Rejoyn™ (developed as CT-152), the...

Healthcare

SyntheticMR receives FDA 510(k) clearance for their next Generation Solution SyMRI 3D

SyntheticMR announced that their next-generation imaging solution with isotropic resolution, SyMRI 3D, has received FDA 510(k) clearance for clinical use in the United States. SyntheticMR...

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