Design & Testing

UL (Underwriters Laboratories), Northbrook, IL, announced that the FDA has recognized two UL battery safety standards as consensus standards for medical devices incorporating lithium or nickel-based batteries. The two standards are UL 2054 - Standard for Household and Commercial...

A team of nuclear engineers at Oregon State University, Corvallis, say that they have developed a small, portable, and inexpensive radiation detection device to help users understand whether or not their surroundings pose a health risk. They say that the technology used in the new device provides...

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 draft...

The U.S. Food & Drug Administration (FDA) has issued the first phase of its Global Unique Device Identification Database (GUDID): Guidance for Industry on June 11, 2014. To quickly provide industry with information critical to successful use of the GUDID, the FDA is issuing the GUDID Guidance in two...

The FDA has recently issued a draft guidance titled, "Humanitarian Device Exemption (HDE): Questions and Answers." This draft guidance answers commonly asked questions about Humanitarian Use Devices (HUDs) and the Humanitarian Device Exemption (HDE) authorized under section 520(m) of the...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