Design & Testing

The FDA has recently issued a draft guidance titled, "Humanitarian Device Exemption (HDE): Questions and Answers." This draft guidance answers commonly asked questions about Humanitarian Use Devices (HUDs) and the Humanitarian Device Exemption (HDE) authorized under section 520(m) of the...

William “Bill” Cook started Cook Medical out of a spare bedroom in his Bloomington, IN, apartment in 1963. It was where he and his wife, Gayle, made guide wires, guiding catheters, and other small devices used in diagnostic radiology.

Using an inexpensive 3D printer, biomedical engineers at Washington University in St. Louis, MO, say that they have developed a custom-fitted, implantable device with embedded sensors that could treat cardiac disorders.

Medical devices are not always one size fits all, especially with regard to child-sized devices. The Philadelphia Regional Pediatric Medical Device Consortium (PPDC) brings together engineers and biomedical researchers from the Children’s Hospital of Philadelphia (CHOP), Drexel...

Plastics can be made scratch-proof and flame-proof, or given antibacterial properties through the addition of nano-sized additives mixed in with the pellets of plastic during the manufacturing process. However, the particle distribution within the plastic compound must be absolutely precise. A new device being...

How can you measure forces acting between two components within a device without drilling holes or sticking on a sensor? Researchers at the Technischen Universität Darmstadt, Germany, have developed a simple solution: a screw with an integrated sensor.

Electromagnetic fields can interfere with or damage electronic devices. Electromagnetic radiation is invisible to people. A new measuring instrument being developed by Fraunhofer-Gesellschaft, Muenchen, Germany, can help determine the strength, frequency, and direction of the attack.

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), West Conshohocken, PA, has proposed a new international standard to be used in the design, development, quality control, and comparison of a variety of collagen-based medical products, including surgical...

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), West Conshohocken, PA, has proposed a new international standard to be used in the design, development, quality control, and comparison of a variety of collagen-based medical products, including surgical implants, delivery...

The American National Standards Institute (ANSI) has launched the ANSI IBR Portal, an online tool for free, read-only access to voluntary consensus standards that have been incorporated by reference (IBR) into federal laws and regulations.

A team of researchers from Stanford University and the Department of Energy’s (DOE) SLAC National Accelerator Laboratory have made the first battery electrode that heals itself, opening a new and potentially commercially viable path for making the next generation of lithium ion batteries.

Scientists at the Weizmann Institute, Rehovot, Israel, have taken a quantum leap toward understanding the exciting phenomenon of superconductivity. They have created the world’s smallest SQUID, a Superconducting QUantum Interference Device, used to measure magnetic fields, breaking the world...