FDAnews Device Daily Bulletin

The FDA’s draft guidance on the PMA acceptance process follows transparency and time goals outlined during recent FDA-industry Medical Device User Fee Act (MDUFA) negotiations and provides details that will help ensure a smooth and productive review, industry comments suggest.

Devicemakers in Canada must now pay a fee to renew their establishment licenses annually by April 1, or face cancellation and enforcement actions, according to an updated Health Canada guidance.

Heart failure is the most frequent condition associated with re-hospitalization.

Wireless carriers and medical device makers should benefit from a number of initiatives being launched by the FCC to promote deployment of wireless medical devices and applications.

A report from a Federal Communications Commission (FCC) mobile health task force includes five overarching goals for making mHealth, wireless health and e-Care solutions a routine part of best medical care practices by 2017.

BD Diagnostics has been given the green light to market its new clinical test kit for rapid detection of influenza A and B.

Mainstay Medical, a start-up device company targeting lower back pain, will relocate to Ireland following a $20 million fundraising led by Irish VC group Fountain Healthcare Partners.

FDA reviewers expressed concern over the long-term safety of what could be the first retinal prosthesis device despite evidence that it helps improve the vision of some nearly blind patients.