The Trump administration is seriously considering three candidates to become US Food and Drug Administration commissioner when the legally mandated 210-day term of acting commissioner Norman “Ned” Sharpless ends on 4 November.
While four former FDA commissioners on 3 September endorsed Ned Sharpless, the agency’s acting commissioner, to be the Trump administration’s permanent choice to lead the agency, an M.D. Anderson Cancer Center oncologist or Harvard University dermatologist may also be chosen.
Besides Sharpless, the other two candidates being considered to lead FDA are Harvard University dermatology professor Alexa Boer Kimball and...
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
The ceramic device, designed to reduce complications, will be exclusively distributed by Zimmer Biomet and initially available in 30 hospitals, with broader European access expected by 2026.
After receiving FDA clearance for its Genio sleep apnea implant, Nyxoah plans a major US rollout despite a patent suit from rival Inspire Medical. Genio offers bilateral nerve stimulation as a CPAP alternative, with strong trial results.
Synchron is preparing a pilot study of its fully wireless, second-gen brain-computer interface after an ALS patient controlled an iPad solely by thought. If all goes as planned, Synchron’s BCI will move into pivotal trials in 2026.
A Japanese study of Watchman LAA closure devices found that leaks of any size after implantation raise the risk of stroke. The study comes shortly after the US FDA issued an early alert for the Watchman access systems.
A late-August batch of device classifications from the US FDA includes genetic tests from 23andMe, hand-held spinal surgery tools, and several IVDs.
Amendments to Germany’s – barely in force – health reform law will be decided after the summer break. The new DRGs payments plan and service groups will be reviewed, but critics fear for the law’s future.
