MEDICAL DEVICE NEWS MAGAZINE

Sunday, September 25, 2022

MEDICAL DEVICE NEWS MAGAZINE

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FDA

GE Healthcare Receives FDA Clearance for Vivid Ultra Edition

Methodical assessments of heart function are key in echocardiography but can be tedious and time-consuming to acquire. High-quality data acquisition and operator skill are key elements to achieve accurate and complete exams.

Gold Standard Diagnostics Receives FDA 510K for Lyme IgG and IgM EIA Kits

Gold Standard Diagnostics advises the assays are available immediately in the US.

FACSLyric Flow Cytometer with Newly Integrated BD FACSDuet™ Sample Preparation System Receives FDA Clearance

The new integrated system enables clinical laboratories to fully automate the sample to answer process and improve their efficiency by reducing errors and limiting the manual user interactions required to run assays on the BD FACSLyric Flow Cytometer.

3D GraftRasp System Including Spine Indications Receives FDA 510(k) Clearance – Approved for General Orthopedic Use and Spine Proccedures

The 3D GraftRasp System is the only device to receive FDA clearance that allows for both decortication of bone and the delivery of autograft, allograft or synthetic bone graft.

Opiods: FDA Finalizes Guidance to Encourage Development of Novel Medicines to Treat Opioid Use Disorder

"As we combat the COVID-19 crisis, we are also focused on addressing the other health crises facing our country, including the ongoing substance use disorder and overdose crisis that our country is battling. Drug overdose deaths continue to rise in our country, and opioids, especially synthetic opioids, continue to be a driver of that trend.

Resolute Onyx Drug Eluting Stent Receives FDA Approval for New 1 Month DAPT Labeling With Expanded Indication for HBR Patients Implanted with the Resolute...

Clinical studies have demonstrated that Resolute Onyx DES and its biocompatible polymer and stent design promote fast vessel healing and is well-suited for patients who may benefit from a DAPT duration as short as one month.

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