Can Da Vinci Xi Turn Around Intuitive Surgical?
More than a year after it received FDA approval, the fourth generation of the Da Vinci surgical robot is seeing strong interest from customers. Now the company just needs to improve its margin on the product.
Is That OUS Data Good Enough for FDA?
FDA publishes draft guidance on what trial sponsors should consider if planning to use data from trials conducted outside the United States to support U.S. approval.
Virtual Approaches to Taming Diabetes Get Currency
CDC provides pending recognition status to digital health companies whose online versions of its National Diabetes Prevention Program is helping at-risk people from getting Type II diabetes.
MDMA Pushes Back on Innovation Act
The Medical Device Manufacturers Association petitions House Committee to think better of passing H.R. 9, The Innovation Act.
FTC: MelApp Can't Make Melanoma Claims
The Federal Trade Commission issues a final order barring a mobile app developer from allegedly making false claims about its ability to assess melanoma risk.