Finding a Manufacturing System Upgrade to Match In-House Innovation

Radiation medicine pioneer Elekta is growing fast. In anticipation of regulatory changes requiring more documentation and labeling, the company implemented a...

Is Healthcare Ready to Pick Up the Pace in Cybersecurity?

Healthcare organizations face very difficult choices in balancing patient protection with financial demands.

New Requirements for Medical Device Cleaning Validations: An Overview of ST98

As medical devices become more advanced and innovative, so do the regulations that surround them.

Creating Robust Reprocessing Instructions for Reusable Device IFUs

Developing IFUs for reusable devices presents a unique challenge that requires focused attention to ensure patient safety: the reprocessing method.

Nanosensor-Based Device Enables Early Detection of Sudden Cardiac Death

A nanosensor-based system measures cardiac micropotential energies.

How Patent Landscape Studies Can Guide Medical Device Innovation

By design, the patent system generates a wealth of technical know-how with respect to new technologies. It chronicles the technical challenges others have faced in the past and...

Early Detection of Neuro Diseases

A new wireless eye-tracking technology is based on electro-oculography (EOG), an ophthalmology technique used to examine eyes and record eye movement. The technology, which is integrated into a standard pair...

Guide to FDA Requirements and Importance of Medical Device Calibration

Calibration of a device is carried out to minimize the uncertainty in measurements. It helps in reducing the errors and brings the measurement to an acceptable level....

Gaming Camera Aids MS Treatment

A device commonly found in living rooms around the world could be an inexpensive and effective means of evaluating the walking difficulties of multiple sclerosis (MS) patients. The Microsoft Kinect is a 3D...

The FDA’s UDI Rule is Final: What’s Next?

The U.S. Food and Drug Administration (FDA) published the final rule for the unique device identification system (UDI) during the UDI Conference in Baltimore, MD, and released it on September 24,...

Benefits of Using Rigorously Tested Routines From Numerical Libraries

This technology helps technical application developers incorporate mathematical and statistical functionality in their applications, while providing the documentation...

The Automation of FDA Medical Device Design Controls

Every medical device company faces the challenge of navigating through the FDA’s mandatory regulations, and companies have different needs that change as they mature. Early-stage medical...

Cloud-Based Product Lifecycle Management for the Medical Industry

The medical industry stands to benefit immensely from cloud-based product lifecycle management (PLM). The mountains of information that medical companies must manage when...

High-Resolution Ophthalmic Ultrasound System for Ocular Structures

An ophthalmic ultrasound system evaluates ocular structures more clearly by providing images of all aspects of the anterior segment. It provides images of the eye and tissues...

Digital Wound Measurement and Tracking System

Historically, the subjective nature of wound treatment has lead to many trial-and-error therapies to match wounds with the right treatment. The WoundMatrix™ digital wound measurement and...

Wireless, Handheld Electronic Medical Record Application

PocketChart™, available in numerous medical specialty editions, is a wireless, handheld electronic medical record application that will help physicians increase productivity, reduce...