FDAnews Device Daily Bulletin

A 16-month Senate Finance Committee investigation of Medtronic revealed dubious ties with researchers and behind-the-scenes efforts to ensure medical journals portrayed the company’s InFuse bone graft favorably, according to a report released Wednesday.

Brazil’s Anvisa last month approved a resolution allowing drug- and devicemakers to register products that are in development, as well as technology transfers performed in a public/private or public/public partnership.

Icon, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, and Korea National Enterprise for Clinical Trials have signed a partnership agreement that aims to advance the clinical trials industry in South Korea.

The Swedish company Laccure AB recently got CE marking for a Class IIa medical device product to treat and prevent bacterial vaginosis (BV), with a proven cure rate of 80 percent already after one vaginal tablet.

Researchers have discovered the Kanzius external radio-frequency device doesn't need nanoparticles — microscopic pieces of metal injected into cells — to effectively kill cancer.

In HIV-plagued Sub-Saharan Africa, it can take up to three months for mothers to learn whether the deadly virus has infected their babies, delaying what could be life-sustaining treatment.

A new 3D heart-mapping device — similar to a car GPS system — is set to revolutionize cardiac surgery in the United Arab Emirates.

Heraeus announces the opening of a new Singapore facility to support expansion of their Medical Components Division.