Members of a US House Appropriations Subcommittee interrogated FDA Commissioner Scott Gottlieb on the agency's proposed 2019 budget and his newly released device safety plan. One fierce critic, Rep. Rosa DeLauro, D-RI, attacked Gottlieb's efforts to allow third-party certifiers to approve device quality manufacturing processes, and said his safety plan looked like a "high-risk" action plan.
While US FDA Chief Scott Gottlieb's ongoing reforms and the agency's FY 2019 budget requests were well-received by most members of a House Appropriations Subcommittee hearing on April 17, some on the panel said Gottlieb's budget priorities would relax regulations too much.
Budget authority for the FDA device center would rise from $327m in 2018 to $455m in 2019, plus $180m in...
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.
