IoMT/​IoT

RFID & UDI Tracking

RFID medical devices are being used in a variety of applications, including surgical instrument tracking and alert bracelets. Get the latest Unique Device Identification (UDI) news and expert advice here.

Latest Briefs & News

Medtech devices have become smaller over this last decade, and the advancements in connected technology are just beginning.

Now that medical devices are being labeled and uniquely identified to meet the requirements of the U.S. Food and Drug Administration (FDA) Unique Device Identifier...

INSIDER: Sensors/Data Acquisition
Toilet Seat Detects Congestive Heart Failure

A toilet-seat based cardiovascular monitoring system aims to lower the hospital readmission rates of patients with congestive heart failure. The toilet seats, which would be purchased by...

INSIDER: Sensors/Data Acquisition
Wearable Device Captures Cancer Cells from Blood

A prototype wearable device, tested in animal models, can continuously collect live cancer cells directly from a patient’s blood. The device could be an alternative to biopsy and could...

Meeting the requirements for patient-connected medical devices can present challenges for power system designers. There are several key elements to consider, including isolation,...

On October 10, 2018, FDA will host a webinar to share information and answer questions about the Quality in 510(k) (“Quik”) Review Program pilot....

Monitoring in real time what happens in and around our bodies can be invaluable in the context of healthcare or clinical studies, but not so easy to do. That could soon change thanks to new,...

The structures of most medical devices are far too complex to mold as a single piece. Therefore, it is necessary to assemble their components into a finished product. While...

For years, the medical device industry has been leading the adoption of additive manufacturing. With the evolution of high-precision printers that span a large offering of...

Safety and reliability are the key concerns when determining the right power source for a medical device. Lithium-ion (Li-ion) batteries are often considered for their higher...

The next industrial revolution is on its way. It is bringing innovative technologies that are available and proven and placing them in the modern...

Consider for a moment the modern automobile. A car’s computer can pinpoint for a mechanic exactly what’s going wrong, and provide a thorough history of how things have been working (or not) in...

The medical device market has been rapidly changing over the last decade and a key area of change is addressing today’s fast paced data-driven environment. Multiple sources...

Technological advancements are making medical devices increasingly feature-rich and miniaturized: two performance characteristics that are inherently...

In September 2013, the FDA announced new regulations for medical device manufacturers known as UDI (Unique Device Identifier) that would require all medical devices to bear a...

Smart, connected devices are an increasing reality of daily life. It is estimated that by 2020, there will be 33 billion internet devices in the world—enough for 4...

When bringing new medical equipment or portable mobile medical devices to market, manufacturers turn to packaging engineers to develop custom case solutions that can enhance and...

INSIDER: Medical
FDA Amends Reporting Rules to Align with UDI Program

Medical device regulators at the FDA have issued correcting amendments to their post-market electronic Medical Device Reporting (eMDR) requirements to eliminate any disparities between those rules and their Unique Device Identification (UDI) system.

Modern mobile networks are ubiquitous and accessible virtually everywhere, from remote villages in Africa to deep inside warehouses and hospitals. This universal wireless coverage,...

News: Medical
FDA Finalizes Guidance to Manage Medtech Cybersecurity

To strengthen the safety of medical devices, the FDA has finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information. On October 1, the agency issued a final guidance on the content of premarket submissions for the management...

News: FDA/Regulatory
FDA Issues Small Entity Compliance Guidance for UDI

On August 13, The FDA issued a guidance for industry and FDA staff called “Unique Device Identification System: Small Entity Compliance Guide”. This guidance is intended primarily to provide information to the medical device industry, including small businesses, concerning FDA’s...

News: Medical
FDA Issues Draft Guidance on Cybersecurity

Recognizing that the need for effective cybersecurity to ensure medical device functionality has become more important with the increasing use of wireless, Internet- and network-connected devices, and the frequent electronic exchange of medical device-related health information, the FDA has issued a...

With the recent release of the U.S. Food and Drug Administration’s final unique device identifier (UDI) ruling, the race is on for medical manufacturers to comply with the newly proposed...

Medical device companies typically have a complex supply chain bringing products to market. Within their four walls, there are usually multiple...

Like many other devices these days, a select group of fluid connectors can now be found in the growing ranks of “intelligent” products. In addition to moving...

Bluetooth Low Energy (BLE) forms part of the Bluetooth V4.0 specification that has been ratified by the Bluetooth SIG since June 2010. But, in the last 12 months, it has begun...

Products: Sensors/Data Acquisition
Sensor-Enabled RFID Tags

ams AG, Unterpremstaetten, Austria, announces its next-generation sensor-enabled radio-frequency identification RFID tags, the SL13A and SL900A, which enable a simple, low-cost implementation of a new class of...

Diabetes is a widespread metabolic disorder, and having it puts people at increased risk for heart disease and stroke. There are two types of diabetes patients: type...

News: Medical
FDA Finalizes Rule on UDI

Today, the FDA issued its final rule on the unique device identification (UDI) system that, once implemented, will provide a consistent way to identify medical devices. The UDI system should improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems...

Ask the Expert

Dan Sanchez on How to Improve Extruded Components

Improving extruded components requires careful attention to a number of factors, including dimensional tolerance, material selection, and processing. Trelleborg’s Dan Sanchez provides detailed insights into each of these considerations to help you advance your device innovations while reducing costs and speeding time to market.

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