Advamed 2013

Devices & Diagnostics

Will FDA step in with lab development tests?

In her speech at Advamed 2013, FDA Commissioner Dr. Margaret Hamburg said a new challenge will be regulating in some way lab development tests. Now, LDTs are left to CLIA, which, Hamburg said,¬†does not ensure they are properly designed, consistently assembled or clinically valid. She called for a “critical baseline” of these sorts of in […]

Devices & Diagnostics

Cigna chief medical officer says ‘gap of hopefulness’ separates FDA approval & reimbursement

Cost effectiveness and outcomes drive value for payers, Cigna‘s Chief Medical Officer Alan Muney said. While some medical device companies assume an FDA approval will mean a definite reimbursement nod from payers, these two forces drive a sometimes wrongheaded “gap of hopefulness” for the industry. (See his discussion of why device companies need to think […]

Devices & Diagnostics

Medtronic VP offers 3 steps for medical device companies to prepare for an FDA submission panel meeting successfully

It’s stressful. If you’re a startup, your company depends on it: it’s your FDA panel meeting. And, as Michael C. Morton, the vice president of global regulatory affairs at Medtronic (MDT), said, “It’s kinda culminated with throwing the dice.” In the “How to Avoid Making a Bad Submission to the FDA…” panel at Advamed 2013 […]