FDAnews Device Daily Bulletin

The FDA is in the last stages of finalizing a June 2011 guidance on classification of combination products, a senior FDA employee said Thursday.

In an effort to further harmonize Ukraine’s legislative framework with the EU’s, the Ukrainian Cabinet of Ministers has prepared two draft resolutions amending its regulation of implants and in vitro diagnostics (IVDs).

Marking the end to an epic effort that spanned the better part of a decade, OraSure Technologies on Monday initiated retail sale of its OraQuick rapid HIV test for online shoppers.

Boston buyout firm Advent International Corp. agreed Monday to buy listed Dutch medical devices and pharmacies group Mediq NV for $1.33 billion including debt.

Boston Scientific has received regulatory approval to market the RELIANCE 4-FRONT lead, its next generation implantable defibrillation lead now available in Europe and Asia.

The ApnexHypoglossal Nerve Stimulation system is an implantable therapy able to detect the patient’s breathing pattern during sleep and provides mild electric pulses to the hypoglossal nerve that controls the muscles that keep airways open.

Scio Township-based Tanget Medical Technologies believes it has found a way to make intravenous needles in hospitals a less unpleasant experience.

Trivitron Healthcare entered into a partnership with Johari Digital Healthcare to market physiotherapy products, diagnostic care products for global markets.