Articles

Embedded Technologies Help Make High-Speed DNA Testing More Intuitive

Embedded Technologies Help Make High-Speed DNA Testing More Intuitive By Kelly Gillilan DNA analysis has gone from mere theory to a heavily relied upon analytic and diagnostic tool in just a few short decades. But as invaluable as DNA can be, its longtime drawbacks have been the time required to replicate enough of it from...

Ten Truths about Building Safe Software for Medical Devices

Obtaining pre-market approval for a medical device is arduous. Manufacturers must look beyond the strictly technical challenges and focus on the needed environment and culture. They must consider ten fundamental truths—truths that we must tell and truths that we must face—about building and gaining approval for medical devices. by Yi Zheng and Chris Hobbs, QNX...

Given Imaging Submits PillCam® COLON 2 Application to FDA For U.S. Regulatory Clearance

YOQNEAM,Israel – November 27,2012 – Given ImagingLtd{NASDAQ:GIVN),a world leader in Gl medical devices and pioneer of capsule endoscopy, today announced that it has filed a U.S. Food and Drug Administration {FDA) application seeking regulatory clearance to market its PillCam® COLON 2 for visualization of the lower gastrointestinal tract. “Filing for FDA clearance is another important...

Issues with Embedded Device Disclosures: Helping Vendors Improve Their Security

Issues with Embedded Device Disclosures: Helping Vendors Improve Their Security Device vulnerability in the medical field is often a fact of life. Dealing with it when it is discovered by third parties such as researchers can be a delicate issue, but there are ways to deal with it and minimize damage. by Jerome Radcliffe, Mocana...

UL 2560 and Emergency Call Systems: Expanding the standards framework

UL Emergency Call System – Click to view PDF

MEDICAL DEVICE MANUFACTURERS ADDRESS COMPLIANCE MANDATES WITH PRODUCT LIFECYCLE MANAGEMENT

MEDICAL DEVICE MANUFACTURERS ADDRESS COMPLIANCE MANDATES WITH PRODUCT LIFECYCLE MANAGEMENT   By Eric Marks Based on industry statistics, it is obvious that intensified regulatory scrutiny has become a harsh reality for medical device manufacturers. Over the last several years, medical device companies have been hit with injunctions, undergone product recalls, or found themselves operating under...

New Technologies Fuel Growth in the U.S. Patient Monitoring Market

As patient monitoring moves from critical to low-acuity areas within hospitals, and as telehealth increasingly lets patients be monitored in the home, the market for an expanding number of devices is expected to experience rapid growth. by Dr. Kamran Zamanian and Sara Whitmore, iData Research The total U.S. patient moni- toring market is expected to...

Wireless Opportunities in Medical Devices

Introduction It is a classic image: a critically ill patient in a hospital bed connected to various medical devices by wires and IV tubing for monitoring and treatment.  These devices are attached to the wall beside the bed and wired into the hospital infrastructure. While this is certainly still a real and necessary role for...

The Safety of Personal Hygiene and Beauty Therapy Equipment Used in Commercial Settings

In a society that emphasizes a healthy and attractive personal appearance, manufacturers and service providers are offering consumers an ever-widening array of products and services designed to maintain and enhance their physical appearance and overall well-being. One aspect of that trend is the growth in the number and type of electrical grooming, personal hygiene and...

Amendment 1 to IEC 60601-1:2005 on Safety and Performance Published

On July 13, 2012, the International Electrotechncial Commission (IEC) published the first amendment to IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. by Charles Sidebottom, P.E., Secretary, IEC/SC 62A The objective of IEC 60601-1 is to specify general requirements applicable to medical electrical equipment and systems and...

Interview UL Health Sciences Industry

By John Koon, Publisher, MEDS (Medical Electronic Device Solutions) www.medsmag.com Publisher: What is UL’s vision? Dr. Terenzio Facchinetti: When we speak of UL’s vision we need to take two different approaches: one for UL as a global company, the other for the UL Life and Health, which is one of the five UL Business Units...

How Wireless Technologies Impact the Future Development of Healthcare

Reprint with permission from medAdvantech the Digital Healthcare Journal The advancement of electronics in the last decade enables electronic design to be more compact, portable and easier to use. The smaller footprints of individual components, advanced manufacturing and packaging techniques enable medical devices to be very compact. Devices such as ultrasound units, insulin pumps, ECG monitors,...