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...
Learn how to use risk management tools and techniques to streamline medical device and diagnostic product development.
Endologix seems to be taking a proactive stance to nip an AFX manufacturing glitch in the bud, but analysts wonder if the company's portfolio is just too broad. The company expects to share more details by the end of the week.Amanda...
Three of Olympus Corp.'s top executives stayed mum when grilled about emails tied to deadly scope-related infections.Amanda PedersenContaminated Olympus TJF-Q180V closed-channel duodenoscope.It's not uncommon for corporate executives to plead the...
The main theme running through FDA's guidance on ISO 10993-1 is that every medical device should be assessed for its specific risk to the end user.
Extractable/leachable chemistry testing can save, time, money, and animal life for certain classes of devices.
