Digital health appears to be making its way onto the national stage. Yesterday, FDA Commissioner Scott Gottlieb gave the field a shout-out in his remarks to the US House Subcommittee on Agriculture, Rural Development concerning the Fiscal Year 2019 budget request for the FDA.
“The Budget requests new resources for the FDA to make significant investments in advancing critical areas of science,...
FDA Commissioner Scott Gottlieb dropped three new FDA guidance documents today, two draft guidances and a final guidance. One draft guidance is the long-awaited guidance on clinical (as well as patient) decision support, while the other deals with changes to medical software policy based on Congressional mandates in the 21st Century Cures Act. The final guidance is on Software as a Medical Device...
In the first quarter of 2017, we tracked seven digital health-related FDA clearances. While the list isn’t long, it’s varied and relatively novel – from app and device integrations for diabetes treatment to a vest that maps cardiac rhythms. The beginning of this year also rang in some big changes, as the Trump Administration took root and nominated Dr. Scott Gottlieb as FDA deputy commissioner....
Former FDA deputy commissioner Dr. Scott Gottlieb is the rumored choice to head the agency, with the full nomination expected by the end of the day. Like most of the Trump Administration’s other high-office picks, Gottlieb is known for his anti-regulatory stance and is in favor of speeding up the drug-approval process, especially for older generics. Considered more mainstream than earlier choices...
