News

What is a Cleanroom & What Happens in One?

What is a Cleanroom? A cleanroom is a controlled environment in which the number of airborne particles is kept to a minimum. These particles could include contaminants such as dust, airborne microbes, aerosol particles and chemical vapors. The contamination level in a cleanroom is specified by the...

29 Sep, 2020

Vascugenix Prepares to Launch Speed-Torque Device

LITTLE ROCK, Ark., September 15, 2020 - Vascugenix, a medical device company focused on developing innovative products to improve interventional cardiovascular procedures, is preparing to launch its first developed device, the Speed-Torque, in the U.S. market. The Speed-Torque is specially designed to improve the process of guidewire...

15 Sep, 2020

UNC-Chapel Hill Startup Develops ‘Error-Free’ Dose Measurement for Pediatric Patients

This is an excerpt from the article UNC-Chapel Hill startup develops 'error-free' dose measurement for pediatric patients, written by Shellie Edge and published by WRAL TechWire on Aug. 11, 2020. The full article can be found here. CHAPEL HILL, NC – As a patient undergoing chemotherapy, the...

26 Aug, 2020

FDA 510(k) Submission Process: An Introduction & How-To Guide

What is a 510(k) submission? A 510(k) submission is a type of regulatory submission made to FDA called a Premarket Notification. In a 510(k), substantial equivalence to a predicate device on the market must be demonstrated. In other words, the medical device in question must be at...

17 Aug, 2020

Medical Device Design & Development: An Informative Guide

Medical devices make medical intervention easier and more successful. They range from tongue depressors and catheters to pacemakers and medical lasers. Medical devices have been used by clinicians for as long as medical intervention has existed, but within the last several decades, advances in medical device design...

30 Jul, 2020

An Interview with Gilero’s Director of Integrated Systems

The Integrated Systems team at Gilero is dedicated to designing, developing and manufacturing electromechanical medical devices and electromechanical drug delivery systems. While Gilero has been providing design & development services since its inception in 2002, and later added manufacturing services, the addition of a dedicated team for...

02 Jul, 2020

Drug Delivery: An Overview

For centuries, drugs have been used to treat ailments, improve health and extend the lives of both humans and animals. The substances used as drugs have evolved greatly from the mixtures of medicinal plants and other ingredients found in ancient times. As the science of drugs and...

25 Jun, 2020

Gilero Scales Up Face Shield Production

Since the World Health Organization characterized COVID-19 as a pandemic in March 2020, Gilero has been working on a number of initiatives to help alleviate shortages of necessary medical equipment. Utilizing our experienced team of design engineers and deep knowledge of the medical device industry, we began...

14 May, 2020