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Fdanewsdevicedailybulletin

Aug. 24, 2012

Vol. 9 No. 167

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Lawmakers Ask FDA for Greater Transparency of 510(k) Safety Data

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

New International Standard for Labels Replaces Earlier Version

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. Read More

FDA Issues Class I Recall for CareFusion Infusion Pump Due to Keypad Problems

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. Read More

Covidien Conducts Voluntary Recall, Discontinues Duet TRS Reload

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). Read More

Medical Device Recalls Hit Nearly Two-Year High

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. Read More

GI Dynamics Gets FDA Conditional OK for a Trial of its EndoBarrier Obesity Treatment

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. Read More

Federal Circuit Junks Boston Scientific Win in Stent Patent Fight

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. Read More

Medical Products Firm to Create 50 Jobs

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