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Three members of Congress sent a letter to FDA Commissioner Scott Gottlieb to request a meeting to address the agency’s inaction on the numerous reports of adverse events associated with Bayer’s contraceptive device Essure. Read More
The FDA sent an Oct. 23 warning letter to Magellan Diagnostics as part of an ongoing investigation based on data showing its blood lead testing systems provided false results. Read More
With the recall of 465,000 Abbott pacemakers deemed at risk of getting hacked — marking the first ever device recall for a cybersecurity issue — it’s time for a deeper dive on how to protect your product from cyber risk. Read More
The Cook County Circuit Court revived a 2013 lawsuit against DePuy Orthopaedics and Premier Orthopaedics Sales alleging negligence in designing a hip replacement device. Read More
In the first ever recall for a cybersecurity risk, Abbott recalled 465,000 implantable pacemakers for a firmware update to reduce the risk of unauthorized access. The update requires an in-person visit with a healthcare provider. Read More
The FDA expanded Datascope/Maquet’s June 20 voluntary worldwide field correction of certain intra-aortic balloon pumps and designated it a Class I recall. Read More