Check out the full video and read the highlights of US FDA Commissioner Scott Gottlieb's keynote address and Q&A from AdvaMed's 2017 Medtech Conference. Among the issues addressed: Gottlieb touted the agency's device center as the spark of innovation within FDA, and he provided a key update to the agency's digital-health regulation, his hopes for lab-developed test regulations and some substantive points on how industry should respond to the ongoing devastation in Puerto Rico from Hurricane Maria.
FDA Commissioner Scott Gottlieb gave the keynote address Sept. 26 at AdvaMed's Medtech Conference, and he also sat down with AdvaMed President and CEO Scott Whitaker for a public question-and-answer session.
During the conference, in San Jose, Calif., the commissioner touted the agency's device center as the spark of innovation across...
In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.
This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.
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This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.
