FDAnews Device Daily Bulletin

Amplivox, a UK subsidiary of Danish company William Demant, received a warning letter from the FDA following a December inspection of its Oxford manufacturing plant.

The FDA’s recently deployed computer system that ranks imports according to risk was praised in a new government report, but a former agency official says it’s essentially stuck in neutral, citing the report’s chiding remarks about FDA sluggishness in integrating its legacy IT systems.

The Senate approved the FDA Safety and Innovation Act Thursday.

Menlo Park, Calif.-based Nevro Corp. touted FDA approval to launch a pivotal clinical trial of its high-frequency spinal cord stimulation system in treatment of chronic pain.

For three decades Gael Lander fought for her life against the same high blood pressure that contributed to her father’s fatal heart attack and caused a series of debilitating strokes in her mother.

An experimental MIT device that delivers a tiny, high-pressure jet of medicine through the skin without requiring a needle prick has already drawn the interest of pharmaceutical maker Sanofi and other large companies, according to one of its developers.

Regenerative medicine company Tengion has always planned to take its novel tissue generating technology as far as early-stage clinical studies before finding a partner to finance later-stage work.

Advanced Biological Laboratories announced Friday that DeepChekand ViroScore Suite clinical genotyping solutions are now CE-IVD (In Vitro Diagnostics) approved for commercial use in Europe and other countries that recognize CE certification.