How BioSig is using plug and play as a medtech startup strategy

Startups, as a rule, should have a plan for their technology to grow. But it is rare that a medical technology startup aims to be plug and play, fitting into many therapeutic areas from cardio to Alzheimer’s to diabetes. BioSig’s Pure EP, an electrophysiology signal recording and processing system, could potentially provide valuable insight during

What does FDA really mean when something is 510(k) exempt?

FDA undoubtedly provided some good news to the medical device industry last month when it proposed exempting hundreds of moderate-risk devices from 510(k) requirements. But don’t break out the champagne just yet if you happen to be developing a device that appears to be on the list. Even when the agency says a particular generic

Changing your medical device: 6 things you need to know

Medical device regulatory consultant Michael Drues has never liked the phrase “change management.” The words seem boring to him. “Not only does it not have to be boring, it is incredibly important—and can be exciting and dare I say fun,” says Drues, who is president of Vascular Sciences (Grafton, MA). Whether it involves a medical