Testing

FDA has not been able to identify the root cause of Magellan's inaccurate lead test results, and the recall has been expanded to include two additional testing systems.Amanda PedersenFDA is conducting studies with the CDC to identify the cause of...

Zimmer Biomet recalled two implantable spinal fusion stimulators after a routine cytotoxicity test indicated high levels of chemicals that could be toxic to tissues or organs.Amanda PedersenZimmer Biomet is recalling its SpF PLUS-Mini and SpF XL...

Are you aware of the regulatory changes and testing advances involving biocompatibility?Image of an in vitro irritation test courtesy Nelson Laboratories.Biocompatibility testing requirements for medical devices are changing. "A lot of things are...

Medical device designers should consider including packaging in their human factors studies.   Human factors studies are now commonplace during medical device development, thanks to FDA’s guidance “Applying Human Factors and Usability Engineering...

Zimmer Biomet's production delays are not yet in the rearview mirror, and investors seem to be running out of patience with the company's recent "one step forward, two steps back" routine.Amanda PedersenZimmer Biomet CEO David Dvorak told...

Abbott is in hot water with FDA over St. Jude Medical's past mistakes, including what was either a lie of omission - or worse.Amanda PedersenAt best, St. Jude Medical management pussyfooted around the truth back in 2014 during the handling of an...

FDA is taking Abbott Laboratories to task for essentially downplaying manufacturing flaws and cybersecurity concerns related to devices acquired through its $25 billion purchase of St. Jude Medical.Amanda PedersenIt seems Abbott Laboratories...

Medtronic has pulled all unused units of the StrataMR valves and shunts from the market after logging an increase in product complaints, including one reported patient death.Qmed Staff ReportDublin-based Medtronic plc said this week that an...

Mylan said its manufacturing partner for EpiPen devices has expanded a recall of the product in the United States and other markets.Amanda PedersenMylan's manufacturing partner for the EpiPen and EpiPen Jr products has recalled 13 lots of the...