The U.S. FDA has posted yet another two regulations for devices granted market access via the de novo petition program, one of which addresses dry eye by means of pulsatile light emissions. This device may serve as a predicate for many 510(k) devices if estimates of prevalence in the tens of millions in the U.S. are any indication.
Boston Scientific Corp. has inked an agreement with an affiliate of Baring Private Equity Asia to acquire the global surgical business of Lumenis Ltd. for $1.07 billion up front. The med-tech giant has had a relationship with Lumenis for more than two decades and currently sells its urology laser portfolio in the U.S. and Japan. The transaction, expected to close in the second half of the year, expands Marlborough, Mass.-based Boston Scientific’s global urology footprint.