Several US House members are backing a new piece of legislation that would give the US Food and Drug Administration the authority to destroy counterfeit devices when they arrive at points of entry into the country. A Johnson & Johnson executive who specializes in global brand protection provided dramatic testimony before a House health panel on 29 January on the need for the anti-counterfeiting bill.
Medtech counterfeiters are endangering the lives of US patients with their illicit trade in counterfeit devices to American hospitals, and Congress could assist by giving the Food and Drug Administration the authority to destroy the fakes, a Johnson & Johnson executive says.
“Lawmakers play a critical role in strengthening our nation’s laws to reduce incentives for engaging in illegal trade. As such,...
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.
