Opinion: The Food and Drug Administration's updated guidance on wellness devices will help ensure that products are appropriately positioned in the market—while staying away from unsupported, ...

Instead of making life easier for medical device companies, the FDA’s new wearables guidance makes the market more complex.

This seems like an appropriate time to talk about what can be done to improve FDA regulation so that mobile app development can flourish. First I’ll tackle current events that make this a good time to ...

FDA Commissioner Dr. Marty Makary announced Tuesday that wearable devices providing non-medical-grade information will not be subject to FDA regulation, as the agency moves to clarify its approach to ...

The US Food and Drug Administration (FDA) has rejected Biogen’s high-dose Spinraza (nusinersen) for the treatment of spinal muscular atrophy (SMA). The agency chose to decline the antisense ...