CardioFocus (Marlborough, Massachusetts), a developer of the HeartLight Endoscopic Ablation System for the treatment of atrial fibrillation (AF), said that its HeartLight technology is the focus of a multicenter European clinical study for the treatment of drug-refractory persistent AF.

As a proud father of a two-year-old little girl, it's always stories the stories about children that grab my attention the most. Take for instance, a recent one that I wrote, discussing the risk of radiation-induced solid cancers in older children. The story comes from a study published in the journal JAMA Pediatrics and possible appendicitis was cited as a leading cause of abdominal/pelvic CT usage. The first question I asked myself, one that I had never asked before... was if I should be overly concerned if my daughter needs a CT scan. The good news is, one med-tech company...

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...