Draeger Medical Systems is recalling its Jaundice Meter JM-103 and JM-105 models after some users have misinterpreted display messages that have resulted in serious injuries.
An FDA advisory committee concluded that BTG's device for treating severe emphysema patients is safe, but the panel raised concerns about the product's efficacy and whether or not the benefits outweigh the risks.
FDA said a total of 12 patients have died in the past two years after receiving either the Orbera or the ReShape balloon-based systems to treat obesity.
FDA is trying to stop two stem cell clinics from marketing unapproved products and for "significant deviations" from current good manufacturing practice requirements.
As regulatory burdens in Europe have grown, FDA has taken steps toward streamlining. But do efforts aimed at expedited review represent progress or empty promises?
As the medical device industry begins to embrace a new era of healthcare collaborations and risk-sharing contracts, what role might FDA play in that trend? This was the question MD+DI posed to a senior advisor to the commissioner of FDA, and his answer might surprise you.