Category: FDA

Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.

XT-Thrive® Drug Master File (DMF)...

April 17, 2024

X-Therma notes this DMF covers the Chemistry, Manufacturing and Controls (CMC) for this key chemistry innovation, which enables non-toxic cryopreservation for life-saving regenerative medicines.

Simpson Interventions Receives FDA Breakthrough...

April 11, 2024

Simpson Interventions is committed to collaborating closely with the FDA and other stakeholders to advance the development and regulatory review of the Acolyte Image Guided Crossing and Re-Entry Catheter System. The company looks forward to bringing this revolutionary technology to clinicians, and patients in need.

XT-Thrive® Drug Master File (DMF) Accepted by the FDA | Reports X-Therma

April 17, 2024

X-Therma notes this DMF covers the Chemistry, Manufacturing and Controls (CMC) for this key chemistry innovation, which enables non-toxic cryopreservation for life-saving regenerative medicines.

EverLift Submucosal Lifting Agent in a 10mL Syringe Receives FDA Clearance

EverLift is the only pre-filled Submucosal Lifting Agent in the market available in two presentations, 5mL and 10mL, providing physicians the flexibility to use only what they need and potentially reducing costs to hospitals and ambulatory surgery centers.

October 23, 2020

EASEVRx Receives FDA Breakthrough Device Designation for Treating Treatment-Resistant Fibromyalgia and Chronic Intractable Lower Back Pain

EaseVRx is now one of the first virtual reality (VR) digital therapeutics to get breakthrough designation to treat conditions related to chronic pain.

October 21, 2020

Scopio Labs Receives FDA Clearance to Market and Sell Its X100 with Full Field Peripheral Blood Smear Application

Using advanced computational photography imaging and tailored AI tools, Full Field PBS gives clinical laboratories an unprecedented ability to capture digital scans with full field view of the monolayer and feathered edge at 100X oil immersion resolution level.

October 21, 2020

Using NSAIDS, Pain and Fever Medication in Second Half of Pregnancy Could Lead to Complications Reports FDA

NSAIDs include medicines such as ibuprofen, naproxen, diclofenac, and celecoxib. People have taken these drugs for decades to treat pain and fever from many medical conditions. There are both prescription and over-the-counter.

October 15, 2020

See-Mode Technologies Receives FDA Clearance for AI Software That Automatically Analyses and Reports Vascular Ultrasound Scans

The company notes Augmented Vascular Analysis uses deep learning, text recognition, and signal processing technologies to assist clinicians in interpreting and reporting vascular ultrasound studies – typically a manual and error-prone process.

October 15, 2020

BioGX Announces FDA Emergency Use Authorization Submission of Extraction-Free Direct RT-PCR Test for COVID-19

The Xfree® COVID-19 Direct RT-PCR test ("Xfree COVID-19") is a complete test in a single vial, lyophilized in the trusted BioGX Sample-Ready™ format. The user would simply Just Add Water™, the patient sample, and run the test on a validated real-time PCR instrument.

October 13, 2020

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.

October 12, 2020

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.

October 5, 2020

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.

October 5, 2020