The Senate approved the same 21st Century Cures bill passed by the House last week on a 94-5 tally; the bill is expected to be quickly signed by President Obama. Provisions for extra dollars for FDA in the bill means that even with a plan by Congress to adopt a continuing resolution this week freezing FDA funding until April 28, the agency can rely on an additional $20 million set aside for it in Cures in the new year.
Industry groups are celebrating US Senate passage of the 21st Century Cures bill with an overwhelming majority, teeing up the broad-based legislation that includes a range of medtech FDA reforms, research dollars and other provisions to be signed by President Obama.
The Cures bill was approved on a 94-5 vote on Dec. 7 following passage of the same bill by the...
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.
