Paying too much attention to something can be depressing if you’re hoping for change in a particular direction, so device makers might be forgiven for ignoring the goings-on inside I-495, that vaguely circular slab of pavement running ‘round our nation’s capital. So is there any cause for med tech optimism about inside-the-Beltway developments? I’ll just say that you might want to indulge more frequently in a time-tested mood elevator this summer, one that requires no prescription. Device tax repeal in limbo Device tax repeal legislation is...

A lot of warning letters and other FDA enforcement action are addressed to obscure companies, but lately a few big names have come under scrutiny. In a recent posting here at MDD Perspectives, we addressed a warning letter to Edwards Lifesciences, but they’re not the only big name to show up behind the FDA woodshed. Is this a trend or mere chance? I’ll let you decide. FDA recently posted the 483 from an inspection of Intuitive Surgical of Sunnyvale, California, which is not unheard of, but is not...