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