The US Food and Drug Administration released an amendment seeking to speed the deadlines for establishing a unique device identification (UDI) system, or numeric or alphanumeric code on certain medical devices. Specifically, the amendment would apply to “implantable, life-supporting, and life-sustaining”...

Here’s hoping that your Thanksgiving holiday was festive and that everyone at your table found at least one reason to be thankful. Heading into December, here is the latest batch of news from the medical products community. Please click the link for more.

Our thoughts are with those who were affected by Hurricane Sandy and its aftermath. The storm's destructive force was felt across the East Coast, but none were more directly impacted than those within the tri-state area—New Jersey, New York, Connecticut. We recognize that the storm's torrential rains, powerful...

While health technology advances provide new ways to improve patient care, some may also create new opportunities for harm. To help minimize the risk of technology-related adverse events, the ECRI Institute, an independent nonprofit that researches the best approaches to improving patient care, has released its Top...

A new study shows that many implantable cardioverter defibrillators (ICDs), which are designed to detect and correct dangerous heart rhythms, are programmed to too low a setting, delivering painful shocks for heart rhythms that aren’t dangerous. Making a simple change in the way physicians set...

The market for microelectromechanical systems (MEMS) used as pressure sensors in medical electronics is likely to grow by 7 percent this year, aided by the use of disposable devices as well as respiratory monitoring, according to iSuppli, El Segundo, CA, a global leader in technology value chain research...

In Brussels, Belgium, the PVCMed Alliance was launched to promote the use and value of PVC in healthcare applications. PVC, or polyvinyl chloride, is the third-most widely produced plastic. The PVCMed Alliance is a coalition of PVC resin and plasticizer producers and PVC converters. The Alliance’s...

Engineers at the University of Michigan, Ann Arbor, tested an energy-harvesting device that uses piezoelectricity — an electrical charge generated from motion — to convert energy from a beating heart to provide enough electricity to power a pacemaker. As reported in a study presented at the American Heart...

The Cleveland Clinic, a nonprofit multispecialty academic medical center in Cleveland, OH, has announced its list of Top 10 Medical Innovations that will have a major impact on improving patient care within the next year. The list is made up of devices, including a handheld optical scan for...

Within all polymers, there are structural flaws at the molecular level. In an ideal network, each polymer chain would bind only to another chain. In reality, though, many of the chains bind to themselves, forming floppy loops that can weaken the network. A team of chemical engineers at Massachusetts Institute of...

The US Food and Drug Administration has set new review timeframes and performance goals for 510(k) premarket notification reviews of medical devices following Congressional approval of the Medical Device User Fee Amendments of 2012 (MDUFA III) earlier this year. By 2017, the agency intends to reduce the...

Researchers at Aalto University, Otaniemi, Espoo, Finland, have developed a durable and affordable nanofibrillar cellulose(NFC) film platform to support medical testing. New environmentally friendly, reliable NFC platforms are more diverse than plastic films, they report. The new type of film can be...

The long awaited proposed Regulations for Medical Devices (and active implantable medical devices) and IVDs were released by the EU Commission. A new free white paper from the Emergo Group, Austin, TX, which provides regulatory consulting, explains several detailed items in the proposed...

Currently available commercial medical tapes work well to keep medical devices attached to the skin. But removing them can sometimes lead to skin tissue tearing, especially in babies and the elderly — those with the most fragile skin. Skin tears in babies and the elderly can range from skin irritation...

A newly released annual report from Ernst & Young, Pulse of the Industry, reveals that publicly traded medtech companies in the US and in Europe turned in a solid performance in 2011, with revenue growth outpacing 2010 rates and delivering a third consecutive year of double-digit net income...

For decades, overtightening was blamed for causing surgical screws and plates used in bone repair to irreversibly fuse together, making subsequent removal difficult for the surgeon and traumatic for the patient. But a new study from the University of Dayton Research Institute, Dayton, OH, explains...