FDA Grants Breakthrough Device Designation for New Cluster Headache Treatment
Last fall, the FDA granted the Belgian company Man & Science a Breakthrough Device Designation for a minimally invasive, innovative neuromodulation therapy device used to treat chronic cluster headaches. The occipital nerve field stimulation system uses mild electrical currents to treat medication-resistant patients with medically refractory chronic headache.
Prior research found that occipital nerve stimulation can lead to a 50% reduction in headache pain for some patients. Its use is also being investigated to treat migraines, occipital neuralgia and fibromyalgia.
“This breakthrough designation should accelerate our market authorization process in the U.S.,” says Robert Taub, CEO of Man & Science.
Clear Eyes, Clear Mind? Cataract Surgery May Lower Risk of Dementia
A longitudinal study of over 3,000 people published in JAMA Internal Medicine last December found that people over 65 who had cataract surgery had a 30% lower risk of eventually developing dementia, including Alzheimer’s. Benefits from the surgery lasted at least 10 years.
Researchers aren’t yet sure why better eyesight is associated with better brain outcomes. One theory is that cataract-free eyes see more blue light, which regulates sleep cycles. Another theory is that better sight means improved sensory input, which can boost brain health.
The study also found no link between eye surgery for glaucoma and decreased risk for dementia.
Physician Assistants or Physician Associates — and Does It Matter?
The newly renamed American Academy of Physician Associates wants the assistant gone from the PA title.
“PAs are versatile and collaborative medical practitioners whose diagnosis and treatment decisions are held to the same medical and legal standards as physicians,” writes PA student Scott Burns in the Journal of the American Academy of Physician Assistants. “We can try to change what the world naturally associates with the word assistant or change our title to fit the world’s natural associations.”
However, the AMA remains opposed to the change, especially in regards to statutory definitions, saying in a statement that it “will only serve to further confuse patients.”
As legislative pushes for title changes spread across the country, expect more activism on both sides.