FDAnews Device Daily Bulletin

Smith & Nephew has agreed to pay the U.S. government $22.2 million to settle allegations it bribed Greek doctors to encourage the use of its orthopedic products.

A proposed Indian rule that would let ethics committees decide the cause of serious adverse events (SAE) and the level of SAE compensation provided to trial participants could make conducting high quality, scientifically valid trials in the country impossible, the Association of Clinical Research Organizations (ACRO) says.

The FDA has granted 510(k) clearance for AngioDynamics’ NeverTouch Direct procedure kit.

A trio of lawmakers are asking a federal office why it has taken so long to review a stalled medical device tracking rule.

Federal health officials say a New Jersey company has been legally barred from making and selling a variety of dental products due to violations at its manufacturing facility.

Mary Davidian, of Highland Ophthalmology Associates, a leading eye surgeon, offers her patients a unique corneal wound repair and healing device called ProKera, the only medical device that can provide wound healing to patients afflicted with a damaged cornea.

Southern California based device manufacturer, ReShape Medical, launched its new ReShape Duo intragastric dual balloon.

The FDA’s neurological devices panel will review clinical data from trials of Stryker’s Wingspan brain stent system next month, aiming to address harsh criticisms and public petitions urging the agency to recall the device.

Two major trials are being set up at the University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust to evaluate the accuracy of the new technologies that will be able to assess a woman’s cervix to establish the risk of her having a premature birth, by using electrical impulses to take measurements of the resistance of tissue in the cervix.