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DentalMonitoring Sets New Standard In Orthodontic Remote Monitoring With De Novo Approval By the U.S. Food and Drug Administration (FDA).

DentalMonitoring, the leader in AI-powered remote monitoring for orthodontic treatment, has received De Novo approval from the U.S. Food and Drug Administration (FDA) for...

Healthcare

Brainomix Achieves Breakthrough with FDA Clearance of e-Lung AI Software

Brainomix, a pioneer in artificial intelligence (AI) imaging solutions to enable precision medicine, is proud to announce the FDA clearance of its latest product,...

Automation in AI

Implicity Earns FDA Clearance for New Heart Failure Prediction Algorithm

Cutting-edge tool analyzes data from cardiac remote monitoring devices to assess whether a patient is at high risk of experiencing worsening heart failure, enabling...

Healthcare

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...

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