The president has signed a 2018 appropriations bill to cover costs at federal agencies until Sept. 30. It provides budget authority funding (not including user fees) for US FDA's device activities at $330m – the same as in 2017 – but gives a total boost of $135m to the agency, up to $2.9bn. The president warned Congress he signed the bill "only as a matter of national security," because it contains increases in military spending.
An omnibus spending bill package signed by President Trump March 23 gives US FDA a total funding increase of $135m for the balance of the 2018 fiscal year, for a total of $2.9bn, not including user fees. But specific device program funding would remain flat compared to 2017.
Some of the boost to FDA's budget, nonetheless, would impact device reviews. The increased spending will help fund the new...
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.
