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.

The U.S. Food and Drug Administration announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses. FDA’s guidance document, titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” includes...

The Desyre project couples a reconfigurable substrate with runtime-system software support in such a manner that the medical system-on-a-chip can adapt on demand to various types and densities of faults, system constraints, and application requirements.

AAMI, the Association for the Advancement of Medical Instrumentation, is leading the small-bore connectors initiative, an international effort to decrease tubing misconnections and increase patient safety. Recently, AAMI has released two additional standards focusing on how to design connectors...

Researchers at MIT have developed a method to stimulate brain tissue using external magnetic fields and injected magnetic nanoparticles. The technique allows direct stimulation of neurons, which could be an effective treatment for a variety of neurological diseases, without the need for...

Scientists at the Texas Heart Institute are working to create a permanent artificial heart.

Here is the latest batch of news from the medical products community. Please click the link for more.

Mo Rastgaar, a Michigan Technological University mechanical engineer, and his team have developed a robotic ankle that "sees" where it is going.

A Seoul National University professor developed a synthetic technology that reproduces the sense of touching real human skin. The artificial skin senses pressure, temperature, strain, and humidity. The soft material is also embedded with self-heating elements.

A University of Rochester team has fabricated a material that self-stretches as it cools. The rubber-like polymer reverts back to its original shape when heated.

A “heart-on-a-chip,” built by UC Berkeley bioengineers, houses human heart tissue derived from adult stem cells. The system could one day replace animal models for drug safety screening.

Johns Hopkins University scientists have developed a new method of maintaining resistance-free current. The development will improve the performance of superconducting wires used in MRI medical scanners and other technologies.

University of Tokyo researchers have developed a “fever alarm armband.” The flexible, self-powered device sounds an alarm when the wearer's body reaches a high temperature.

The Assistive Context Aware Toolkit (ACAT) technology, used by famous physicist Stephen Hawking, is now open-source.

Medical devices offer significant health benefits, but must be balanced against certain risks. A strong Medical Device Postmarket Surveillance System (MDS) can provide more robust and timely benefit-risk profiles for devices so that providers and patients can make better...

Researchers from the Universidad Politécnica de Madrid (UPM) have developed nanosensors capable of sticking on uneven surfaces and biological surfaces like human skin.

Surgeons at Children’s Hospital Los Angeles say that three-dimensional printing technology can make surgery safer for children with congenital heart disease, and reduce the duration and number of invasive procedures required. Richard Kim, MD, a cardiac surgeon recently used a 3D printed...

Scientists in field laboratories who diagnose and deal with Ebola infections often work under challenging conditions. Researchers at the German Primate Center have developed Diagnostics-in-a-Suitcase, which contains all reagents and equipment to detect the Ebola virus within 15 minutes at...

While the Japanese art of origami has been “a rich source of inspiration” for scientists working to construct such 3D forms, the limitation to simple shapes has held up development of new applications in areas such as biomimetic systems, soft robotics and mechanical meta-materials, especially...

Scientists have developed the first ultra-thin, flexible device that sticks to skin like a rub-on tattoo and can detect a person’s glucose levels. The sensor, reported in a proof-of-concept study in the ACS journal Analytical Chemistry, has the potential to eliminate finger-pricking for many people with...

A new type of bacteria-repelling nanoscale surface holds promise for medical applications.

Recently, FDA commissioner Margaret A. Hamburg, MD, announced that she was stepping down at the end of March. One of the longest-serving FDA commissioners, Hamburg started in the position in May of 2009. Her job has been demanding and intense, dealing with everything from the rollout of the Affordable Care...