FDA Approvals

FDA approves Eko Health’s Low EF detection AI for detecting heart failure

April 2, 2024 - Eko Health, recognized for its utilization of artificial intelligence (AI) in the early detection of heart and lung conditions, has revealed that its Low EF (ejection fraction) detection AI, integrated into the Eko Stethoscope, has received FDA clearance. "For the first time, United States physicians can now identify Low EF, a crucial heart failure...

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FDA Approves Over-the-Counter Sale of Dexcom CGM

by Veronica Salib

On Tuesday, March 5, 2024, the United States FDA cleared the first over-the-counter continuous glucose monitor (CGM), the Dexcom Stelo Glucose Biosensor System. This new approval marks the first time...

Reproductive Care Research Finds 6% Fewer Abortions Post-Roe

by Hayden Schmidt

A national abortion reporting program found that, on average, 5,377 fewer abortions were performed each month after the Supreme Court struck down Roe v. Wade in June 2022. The study conducted by the...

HHS’s Plan to Address Alzheimer’s Disease Focuses on Care Access

by Hayden Schmidt

Last week, the Department of Health and Human Services (HHS) released its updated National Plan to Address Alzheimer’s Disease, highlighting achievements in the past decade and goals for a 2023...

FDA Issues Emergency Authorization for Roche’s Monkeypox Test

by Hayden Schmidt

The pharmaceutical company, Roche Holding AG, received emergency use authorization (EUA) from the FDA Tuesday for its cobas MPXV test that successfully detected monkeypox in human trials. The test is...

PET Scans Vary in Detection of Amyloid Plaques

by Veronica Salib

As the population in the United States continues to age, dementia and other neurodegenerative diseases have become an increasing concern. Diagnostic tools for Alzheimer’s disease are essential as...

FDA Approves New MRI Contrast Agent for Nervous System Imaging

by Hayden Schmidt

A new macrocyclic gadolinium-based contrast agent created by Bracco Diagnostics Inc. gained FDA approval last week after a positive Phase III study. The Vueway injection will be available for adult and...

New Remote Patient Monitoring Technology for Sleep Apnea Announced

by Veronica Salib

On September 13, 2022, Silent Night Therapy announced a new remote patient monitoring technology for sleep apnea. This technology could revolutionize sleep apnea testing, which currently requires...

Bluebird’s Gene Therapy Costs $3 Million per Treatment

by Veronica Salib

On September 16, 2022, the FDA granted bluebird bio accelerated approval for their gene therapy technology, Skysona. This technology is meant to treat active cerebral adrenoleukodystrophy (CALD) in...

FDA Granted SirPlux Duo Drug-Coated Balloon Breakthrough Designation

by Veronica Salib

On September 19, 2022, the FDA granted Advanced NanoTherapies a Breakthrough Device Designation (BDD) for its SirPlux Duo Drug-Coated Balloon (DCB) to treat coronary artery disease. Based on the press...

Aspartame Study Finds Increased Risk of Breast, Obesity-Related Cancer

by Hayden Schmidt

An ongoing NutriNet-Sante cohort study initiated in 2009 analyzed the diet of 102,865 individuals and found that people who consumed high amounts of aspartame were associated with a 22% higher...

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