An FDA panel meeting last week on CardioMEMS Inc.’s PMA for its Champion implantable heart failure monitor was dominated not by the firm’s clinical data but by findings from FDA’s pre-market clinical-site inspections pointing to bias in that data.
The result: CardioMEMS appears to be facing an uphill battle at best for approval. That is a disappointing surprise not only for Atlanta-based CardioMEMS, but also for St. Jude Medical,...