Luna Diabetes says it has launched a pivotal trial for what it describes as “the world’s smallest insulin patch pump.”

The agency cleared one of two 510(k) submissions iRhythm filed for the heart monitor after receiving a warning letter from the agency last year.

Medtronic (NYSE: MDT)+
announced today that it received FDA investigational device exemption (IDE) for its Prevail drug-coated balloon (DCB).