FDAnews Device Daily Bulletin

If the FDA follows the recommendations of two Democratic lawmakers, 510(k) databases could soon include more information about recalls and other safety problems.

European medical devicemakers will be required to use a new labeling standard that reduces the need for multiple languages on a single label and reduces potential confusion and delays for selecting the appropriate language when using a device.

U.S. health regulators announced a recall of CareFusion’s Alaris pump module Model 8100, saying a potential keypad malfunction in the infusion pump could cause serious injury or death.

Covidien announced it is conducting a voluntary recall of all production lots for the Duet TRS Universal Straight and Articulating Single-Use Loading Units (SULU).

Nearly 123 million medical devices, such as ultrasound gels and hip implants, were hit with recalls in the last quarter, making for a nearly two-year high.

GI Dynamics announced it has received conditional approval from the FDA to start a pivotal clinical trial of its EndoBarrier device for the treatment of patients who have uncontrolled Type 2 diabetes and who are obese.

The Federal Circuit said Wednesday that a lower court had incorrectly constructed patent claims when it found that Boston Scientific Corp. hadn't infringed an inventor's patents on coronary stents, tossing a ruling of noninfringement and remanding the case for a second time.

Fifty new jobs are coming to Dublin through the expansion of a research development and innovation facility at University College Dublin.