A young company developing a product to address secondary lymphedema, a chronic disease with no cure, stole the show at a venture competition held during a recent medical device conference. Working with Stanford University (Stanford, California), Fibralign (Sunnyvale, California) developed BioBridge, a surgical device designed to support the formation of new functional lymphatic vessels.
The news is out that the Supreme Court (SCOTUS) passed on the chance to hear Medtronic v. Stengel, one of the more recent cases tackling FDA’s preemption of state tort law for PMA devices, so maybe it’s time for a preemption check-up. First, it may be instructive to ask “why not Stengel?” The case had bounced from a district court (which dismissed the suit against Medtronic) to the U.S. Ninth Appeals Court, which handed it back to the lower court after seeming to suggest...