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.

Intuity Medical’s POGO Automatic ®,...

May 2, 2024

Recognized by healthcare professionals for its user-friendly design which can improve testing compliance, POGO Automatic is endorsed as the ideal solution for many diabetes patients by Rosemarie Lajara, MD, an endocrinologist with Southern Endocrinology & Diabetes Associates, P.A. in Plano, Texas

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.

Intuity Medical’s POGO Automatic ®, the First and Only FDA-Cleared Automatic Blood Glucose Monitor, Now Covered by Medicare Part B

May 2, 2024

Coronavirus (COVID-19) Update: FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing

An EUA to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to four individual swab specimens collected under observation. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples.

July 18, 2020

Soliton Receives FDA Acceptance for 510(k) Application

The device is already indicated as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients and this latest new application is for the temporary improvement of the appearance of cellulite.

July 15, 2020

GI Supply Notes EverLift Submucosal Lifting Agent is 1st Submucosal Lifting Agent in a Pre-filled 5mL Syringe Receives FDA Clearance

EverLift™ Submucosal Lifting Agent formulation is cellulose based, making it hypertonic. This results in a lifting agent that is specially formulated with water-retaining properties, which causes a slower rate of absorption because of osmotic resistance.

July 14, 2020

Avicenna.AI Secures FDA Clearance for Its CINA Head Neurovascular Imaging Artificial Intelligence Tool

Cyril Di Grandi, co-founder, and CEO of Avicenna.AI said, "We're excited to have received FDA clearance for CINA Head and are looking forward to working with emergency departments and stroke centers across the United States to help improve detection, decision-making, and patient outcomes.

July 14, 2020

FDA Prepares for Resumption of Domestic Inspections with New Risk Assessment System

The White House Guidelines for Opening Up America Again are providing us a roadmap for optimizing operations and new work arrangements, as well as the Centers for CDC guidance for protecting workplace exposures to COVID-19 in non-healthcare settings.

July 10, 2020

Infervision Receives FDA Clearance for the InferRead Lung CT.AI Product

InferRead Lung CT.AI product is currently in use at over 380 hospitals and imaging centers globally.

July 10, 2020

FDA COVID-19 Update for July 9, 2020

Today, a U.S. District Court in Florida granted a motion for default judgment and a permanent injunction against the Genesis II Church of Health and Healing, Jonathan Grenon, and Jordan Grenon for violating federal law by distributing their product, "Miracle Mineral Solution

July 9, 2020

Dascena Receives FDA Breakthrough Device Designation for Machine Learning Algorithm for Earlier Prediction of Acute Kidney Injury

Acute kidney injury commonly affects hospitalized individuals, and if not caught early, can result in dangerous outcomes for patients.

July 7, 2020

ivWatch SmartTouch™ Sensor Receives FDA Clearance

Designed with direct clinician input, SmartTouchTM is a single-use sensor that is cleared for all patient age groups. The new miniaturized and disposable sensor adds functionality options for IV site placement, particularly for neonates, for monitoring IV sites of more active patients, and for longer dwell times.

July 7, 2020