Medical Device Integration

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...

Read More


More Articles

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...

FDA Issues Draft Guidance for Using RWD in Medical Device Regulation

by Veronica Salib

On December 18, 2023, the United States Food and Drug Administration (FDA) published a draft guidance called “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical...

Researchers Identify Depression Recovery Biomarkers Using DBS Device

by Veronica Salib

A recent study published in Nature with support from the National Institutes of Health (NIH) Brain Research Through Advancing Innovative Neurotechnologies Initiative, otherwise known as the BRAIN...

FDA Issues Three New Draft Guidance Documents for Medical Devices

by Veronica Salib

Last week, the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) issued three new draft guidances to alter the 510(k) program. According to a statement...

GE Healthcare Reveals Pioneering Artificial Intelligence Tool for Faster MRI

by Hayden Schmidt

GE Healthcare is promising to slash the time needed for an MRI using its new deep learning (DL) tool. Sonic DL, the name given to their state-of-the-art image acquisition accelerator, can reduce scan...

Over-the-Counter Hearing Aids Launched

by Veronica Salib

On October 17, 2022, Lucid Hearing officially launched its line of over-the-counter hearing aids. The launch follows an FDA ruling earlier this year that allowed for the over-the-counter sale of...

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...

Temperature-Controlled Radiofrequency Device Improves Nasal Obstruction

by Veronica Salib

A recent publication in JAMA Otolaryngology-Head and Neck Surgery analyzed the outcomes of temperature-controlled radiofrequency (TCRF) device treatment for patients with nasal airway obstruction...

Oral and Temporal Thermometer Readings Differ in Black Patients

by Veronica Salib

Temporal thermometers are widely used in hospitals, physicians’ offices, and homes to identify fever. Despite their universally accepted uses, there has been little data to determine whether...

FDA Announces Malfunctions in Abbott’s MitraClip Device

by Veronica Salib

Mitral regurgitation typically requires a heart valve repair or replacement. Abbott’s MitraClip Clip Delivery System was approved by the FDA in 2013 as a heart valve repair device. However, on...

AHN Announces Clinical Study Using DBS to Treat Opioid Addiction

by Veronica Salib

On Monday, June 13, clinicians at Alleghany Health Network (AHN) revealed their plans to conduct a clinical study on the effects of using deep brain stimulation — also known as DBS...

Novel Micro Device Simplifies IVF, Male Subfertility

by Alivia Kaylor

A University of Adelaide research team and medical technology company, Fertilis, have produced a novel micro device to simplify the only fertility treatment technique associated with men with low sperm...

RoddyMedical Launches Medical Line Securement Device Invented by Wisconsin Nurse

by Alivia Kaylor

On May 17, RoddyMedical, based in Wauwatosa, Wisconsin, announced the launch of a medical line securement and tension mitigation device, SecureMove-TLC, designed to be the new standard in medical line...

Recent Articles