The FDA has announced new goals to help modernize its procedures and respond to new technologies. In a blog post by FDA Commissioner Scott Gottlieb, M.D., the agency expressed new priorities to help modernize clinical trials...more
The FDA has recently approved Embrace, a smart watch designed to monitor epileptic patients for seizures, according to a press release. According to the press release, the device uses machine learning to monitor patients for...more
On August 29, the FDA announced a recall of 465,000 implantable pacemakers, citing concerns that hackers may be able to take control of the pacemakers’ settings. This would open patients up to danger from improper pacing or...more
The Washington State Supreme Court recently released its decision in Taylor v. Intuitive Surgical, Inc. where it held that Washington law requires medical device manufacturers to warn hospitals that purchase their products of...more
4/8/2017
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Duty to Warn ,
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Hospitals ,
Jury Instructions ,
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Medical Devices ,
Product Defects ,
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Robotics ,
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WA Supreme Court
ICU Medical and Pfizer have reached an agreement to transfer ownership of Hospira Infusion Systems to ICU Medical, according to a joint press release on October 6....more
The FDA recently approved INSIGHTEC’s Premarket Approval (“PMA”) application for ExAblate Neuro, a device designed to treat essential tremor. Essential tremor is the most common kind of tremor; it commonly affects the hands,...more
The U.S. Food & Drug Administration (FDA) has released statistics showing that it inspected fewer medical device manufacturers in 2015 than in 2014....more