Essilor International is paying more than $16m to the US government and an additional $5m to the states to resolve allegations the company offered financial incentives to eye-care providers in exchange for sales.
Dallas-headquartered optical lens company Essilor International and two subsidiaries have agreed to pay at least $22m to resolve allegations that the company violated anti-kickback laws, the US Department of Justice announced on 23 August.
According to DOJ, the company offered payments to optometrists, ophthalmologists, and other eye-care professionals to encourage them to order Essilor...
Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
There is considerable focus at present on how far notified bodies can go in helping position their clients to have as smooth a conformity assessment passage as possible. It is a fine balancing act for all involved, but a new document sheds some useful light.
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.
