There are few seals of approval skeptical Americans are willing to trust blindly. But for most, “FDA-approved” is pretty much synonymous with “safe and effective.” After all, the agency’s M.O. is only putting safe and effective medical devices on the market. It turns out, though, the FDA approval process is super out of date—so much so that the governing body is readily admitting that its own rules aren’t set up to help it keep pace with the advances in material science, digital health, 3D printing, and other tech. Advertisement - Continue Reading Below This admonition comes on the heels of a massive, highly-publicized global investigation into more than 8 million medical device safety records which found FDA-approved devices are causing injury and death. According to the Associated Press’ investigation, for example, faulty spinal-cord stimulators have accounted for more than 80,000 injuries since 2008, with metal-hip replacements and … [Read more...] about Why Do FDA-Approved Devices Keep Hurting People?
What requires fda approval
Get the Better newsletter. SUBSCRIBE Long before apps, there was the rhythm method. With the rhythm method, a woman tracks her menstrual cycles on a calendar to pinpoint when she is ovulating and most likely to conceive — and so avoids sex on those days. This type of natural family planning is far from foolproof, with as many as 24 in 100 women who practice it as birth control getting pregnant in the first year. Over the years a number of apps (Kindara, Period Tracker and Ovia, among dozens of others) have popped up to help women better understand their fertility cycles. These apps simplify data-logging, help women “learn” their cycles and typically factor in other information like body temperature or the consistency of cervical fluid, both of which can indicate ovulation or the time you're most likely to become pregnant. Most of the apps are promoted as pregnancy planning tools and that's how many women use them. OB-GYNs such as Dr. Jamil Abdur-Rahman, clinical … [Read more...] about FDA approved a ‘birth control’ app. Here’s what OB-GYNs want you to know.
By The Washington Post | PUBLISHED: August 14, 2018 at 5:42 pm | UPDATED: August 14, 2018 at 5:42 pm By Rachel Siegel Contraception? Yes, there’s an app for that. And an FDA-approved app at that. Last week, Natural Cycles became the first app approved by the government to prevent pregnancy. The Swedish-based company had been cleared in Europe in 2017 and is an emerging name within the “Femtech” industry — a catch-all for “female health technology” that has reaped an estimated $1 billion of investment worldwide in the past three years. This app is marketed as “a natural method of contraception that is powered by a smart algorithm.” It sells the idea of “empowering women.” Not all are convinced that the app represents the future of contraception, or should even be used now. Women might be drawn to having a sense of control over their reproductive lives. And as with so much else in modern daily life, their data is at their … [Read more...] about FDA approves an app to prevent pregnancy. Can an app do that?
0 View Comments WASHINGTON — U.S. health regulators on Monday approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use. The Food and Drug Administration approved the medication, called Epidiolex, to treat two rare forms of epilepsy that begin in childhood. But it's not quite medical marijuana. The strawberry-flavored syrup is a purified form of a chemical ingredient found in the cannabis plant — but not the one that gets users high. It's not yet clear why the ingredient, called cannabidiol, or CBD, reduces seizures in some people with epilepsy. British drugmaker GW Pharmaceuticals studied the drug in more than 500 children and adults with hard-to-treat seizures, overcoming numerous legal hurdles that have long stymied research into cannabis. FDA officials said the drug reduced seizures when combined with older … [Read more...] about FDA approves first ever marijuana-based drug for seizures
Story highlights The FDA has approved a preventive treatment option for migraine patients It should be available within a week and is expected to cost $575 monthly or $6,900 annually (CNN)Migraine sufferers across the United States have their eyes on a newly approved drug that's offering hope for reducing the frequency of monthly migraine attacks. On Thursday, the US Food and Drug Administration approved Aimovig for the preventive treatment of migraines in adults with episodic or chronic migraines. Episodic migraine is when symptoms occur zero to 14 days each month; symptoms of chronic migraine occur 15 days or more a month. Aimovig is administered through monthly self-injections. Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, or CGRP, a molecule that is involved in migraine attacks. Aimovig targets that molecule's receptor in your body. The treatment, … [Read more...] about FDA approves preventive migraine treatment