A combined House/Senate "21st Century Cures" package will get a vote in the House on Nov. 30, and soon in the Senate. The medical innovation package includes a breakthrough device pathway that, in its current form, would allow 510(k), as well as PMA and de novo, devices to participate. The bill also provides a modest $500m to help support a range of additional FDA device and drug pathway streamlining reforms. Meanwhile, it would authorize $4.8bn for the Precision Medicine Initiative, a BRAIN Initiative, and for cancer "Moonshot" research funds at NIH.
House and Senate lawmakers have released a compromise 21st Century Cures Act including a breakthrough device pathway and other device-related FDA and health-care policy reforms, in advance of planned vote in the House Nov. 30.
The latest version of the legislation, posted online Nov. 25, includes a combination of elements from the comprehensive 21St Century...
Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.
Multi-cancer diagnostics can help get oncology patients the treatment they need more quickly, but lack of reimbursement has kept such tests out of reach for many patients. Bills providing coverage have passed or are under consideration in more than half of the states and have been introduced in both houses of US Congress.
A government report requested by US lawmakers Debbie Dingell and Anna Eshoo to review the FDA’s postmarket surveillance of medical devices stresses that strengthening the system is critical to addressing adverse events linked to devices after they hit the market.
A bipartisan bill now in the US Senate seeks to change the classification of implantable hearing aid devices to allow Medicare to reimburse for the devices, potentially expanding access for many Americans who require them.
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.
