Category: Regulatory

The medical devices Regulatory system is a process that helps to ensure patient safety, quality of care and protection against unauthorized practices.

Dexcom Faces FDA Scrutiny A Wake-Up Call for the CGM Industry

Regulatory

Dexcom Faces FDA Scrutiny: A Wake-Up Call for the CGM Industry

March 11, 2025

Medical Devices

Intuitive Surgical Poised to Remain a Dominant Player in Robotic Surgery Despite Growing Competition and Regulation

March 29, 2023

Access to the EU/UK/Swiss Market after the EU MDR/IVDR Implementation

Regulatory

Getting Products Registered in Europe Access to the EU/UK/Swiss Market after the EU MDR/IVDR Implementation

January 5, 2023

FDA Approves a novel drug, Auvelity for management of Clinical Depression

Regulatory

FDA Approves a novel drug, Auvelity for management of Clinical Depression

October 13, 2022

Doctor showing table of figure heart for cardio

Medical Devices

New Report from Medtronic Explains Safety Problems in Defibrillators

July 21, 2022

Optum Plans to Reduce Unnecessary Lab Tests – Ramifications on Healthcare

Regulatory

Optum Plans to Reduce Unnecessary Lab Tests – Ramifications on Healthcare

July 1, 2022

Regulatory

Two Deaths Triggered The Recall of Baxter Ventilators by The FDA

June 28, 2022

Regulatory

Senate Discusses User Fee Package – OTC Hearing Aid and Lab test Provisions

June 20, 2022

CDRH’s Director Is Optimistic Operations Will Soon Go Back to Normal

Medical Devices

CDRH’s Director Is Optimistic Operations Will Soon Go Back to Normal

May 5, 2022

Regulatory

The FDA’s MDUFA Accountability Questioned at Senate Hearing

April 30, 2022

Regulatory

The First COVID-19 Breathalyzer Test Just Got FDA Approval

April 21, 2022

Regulatory

FDA Pushes for Duodenoscope Switch to Disposable Devices

April 8, 2022

High-Risk Medical Devices: New Safety Requirements Issued

Regulatory

High-Risk Medical Devices: New Safety Requirements Issued

March 30, 2022

MedTech Groups from Germany and France Want MDR Transition Period Extension_featured

Regulatory

MedTech Groups from Germany and France Want MDR Transition Period Extension

March 23, 2022

Philips Must Notify Customers about Recalled Sleep Device, According to FDA

Regulatory

Philips Must Notify Customers about Recalled Sleep Device, According to FDA

March 14, 2022

Reports of Strangulation in Children Caused by Enteral Feeding tubes_featured

Regulatory

Reports of Strangulation in Children Caused by Enteral Feeding tubes

February 17, 2022

Regulatory

FDA Approves Use of a Novel Device for Removing Inferior Vena Cava Filter

February 10, 2022

Regulatory

FDA Approves Quviviq in Patients with Insomnia Disorder

January 31, 2022

Regulatory

FDA Approves a New Interleukin Inhibitor, Risankizumab (Skyrizi) for Patients with Psoriasis Arthritis (Psa)

January 25, 2022

Regulatory

Appointment of a new Belgian Notified Body EU MDR

December 1, 2021

Regulatory

EU roll-out of the new IVD Medical Devices Regulation

October 17, 2021

Regulatory

FDA has reclassified surgical staples, Internal Staples as a Class II medical device

October 9, 2021

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