FDA Approves First Device To Help Opioid Dependency
Medtech company Innovative Solutions has been granted approval by the U.S. Food and Drug Administration (FDA) to release the NSS-2 Bridge device, aimed at managing opioid addiction.
The NSS-2, or Neurostimulation System, works by emitting “electrical pulses to stimulate branches of certain cranial nerves” that may provide relief from opioid withdrawal symptoms, which include gastrointestinal upset, insomnia, and joint pain.
A clinical study observed 73 patients who were undergoing opioid withdrawals, and 64 of them successfully made the transition to medication therapy after only five days of using the device.
Getting More Sleep Staves off Diabetes
A survey conducted in the U.K. has prompted a warning from doctors about insufficient sleep. Of the more than 2,200 adults surveyed in Cardiff, insomnia and disturbed sleep were among the most commonly reported experiences.
Sleep aids and drinking were methods patients admitted to partaking in to help fall asleep. But falling asleep is different than staying asleep. Women averaged less sleep than men, though the precise reasons for that were not clear.
Lack of or too little sleep may be caused by stress, but can also to lead to stress. The Better Sleep Council recommends exercise, napping, and creating a comfortable environment with minimal distraction or electronic devices.
Monsanto Pushes Back Against CA Labeling of Glyphosate
In its efforts to save face, agricultural chemical giant Monsanto is once again taking the state of California to court over its classification of glyphosate as a potentially dangerous chemical.
Glyphosate was first listed as a chemical “known to the state to cause cancer” under Proposition 65 by the California Office of Environmental Health Hazard Assessment (OEHHA) in July of this year. Just a month prior, Monsanto had petitioned for OEHHA to reconsider the decision, to no effect.
While Monsanto has the support of some U.S. farm groups, genetically engineered, herbicide-tolerant crops have made it possible for farmers to apply glyphosate for months after crops had started growing.
Global Diabetes Epidemic Now Costs $850 Billion Per Year
The International Diabetes Federation has estimated that treating diabetes globally is costing a staggering $850 billion per year, around $25 billion more than last year. That makes diabetes the medical condition with the fifth highest economic burden.
The breakdown of medical expenditures includes hospital inpatient care, doctor visits, and prescription medications, which may cause serious side effects and lead to further hospitalization.
The International Diabetes Federation predicts that by the year 2040, the number of diabetes sufferers will climb from 415 million to 642 million.
FDA Accused of Not Acting on Essure Side Effects
In a letter to FDA Commissioner Scott Gottlieb, Congressional representatives Rosa DeLauro (D-Conn.), Jan Schakowsky (D-Ill.), and Louise Slaughter (D-N.Y.) expressed their concerns over the FDA not doing more to address Essure side effects.
The representatives wrote that the device is “a prime example of systemic medical device oversight shortfalls and insufficient enforcement to ensure the safety and efficacy of medical devices.”
Essure is a contraceptive system comprised of two metal coils implanted in a woman’s fallopian tubes, made from a combination of stainless steel, nickel titanium, and polyethylene fiber materials.
Serious complications, some leading to death, forced manufacturer Bayer to place a Black Box warning at the FDA’s behest last year, but the device has yet to be recalled in the U.S.