Women May Face Additional Risks From LAAO Treatment, FDA Cautions
The US agency issued a letter to providers in the wake of a study that found significantly higher complication rates in women implanted with Boston Scientific’s Watchman device.
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June, July and August brought a number of important new approvals and trial announcements from the major cardiac device companies. Here are some of the highlights you might have missed during the summer.
For Second Time This Month, Medtronic Announces Class I FDA Recall Related To HeartWare System Component
Medtronic, Baxter and BD are all facing recalls, with Medtronic finding yet another issue with HeartWare HVAD systems. Separately, the FDA put a Baxter respiratory device recall into Class I, and BD announced a recall on intraosseous devices.
US regulators plan to hold a public meeting later this year to address concerns the devices are less accurate for people with darker skin tones.