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NASA will license its FDA-approved ventilator to manufacturers for free
A high-pressure ventilator developed by NASA engineers and designed to treat COVID-19 has received FDA approval via a fast-tracked emergency use authorization.
Lab-in-a-box test can detect COVID-19 in 5 minutes
The FDA has scrambled to allow numerous COVID-19 tests in a bid to control the pandemic, but one of the latest may represent a big step forward in technology fighting the disease. Abbott has received emergency use authorization for a variant of its toaster-sized ID NOW lab-in-a-box that can provide positive results in as soon as five minutes, and all-clear results in 13 minutes. On top of this, it's one of the few tests of its kind that can be used outside of a hospital, such as at a clinic.
FDA allows new coronavirus testing tech before it gets emergency approval
The FDA is determined to step up the pace of coronavirus testing in the US to cope with the recent coronavirus outbreak, and it's willing to greenlight technology at an early stage to make that happen. The regulator said it will allow new diagnostic tech to be used to test for COVID-19 before an Emergency Use Authorization request has gone through a review. This will only apply to validated methods from labs that are certified to handle "high-complexity" tests in line with key requirements, the FDA said, and doesn't amount to lowering standards -- this is only to ensure there's "wide availability" of testing options.
FDA clears algorithms that detect heart murmurs and AFib
The FDA just granted clearance to a suite of algorithms that could help healthcare providers in the US more accurately screen for heart conditions during routine physical exams. The algorithms, developed by Eko, can help detect both heart murmurs, indicative of valvular or structural heart disease, and atrial fibrillation, or AFib, which can lead to blood clots, strokes, heart failure and other complications.
FDA warns hospitals about security flaws in some GE medical equipment
Some GE medical equipment have vulnerabilities that make them easy to tamper with, according to the FDA. The agency has warned hospitals and healthcare providers that a third-party cybersecurity firm has identified flaws in certain GE Healthcare Clinical Information Central Stations and Telemetry Server models. Hospitals use these devices to monitor patients' information, including their temperature, heartbeat and blood pressure, and are usually located in the nurse's bay or other central locations within a facility.
FDA bans production, sale of fruit- and mint-flavored vape pods
Today, the FDA officially banned most fruit- and mint-flavored, cartridge-based vaping products. The new rules are yet another attempt to curb teen vaping. Companies that manufacture, sell and distribute such products have 30 days to comply.
WSJ: FDA vape ban will target fruit flavored pods
A few days ago, the FDA officially raised the minimum age of sale for tobacco products from 18 to 21, and according to a Wall Street Journal report, it's close to announcing a new set of restrictions specifically for e-cigarettes. In a move that is supposed to address teen vaping by targeting products they're interested in, the new rules will reportedly apply only to pod-based vaporizers, like Juul or NJOY, and remove any flavors from sale other than tobacco or menthol. In anticipation of the ban, Juul stopped selling sweet fruit-flavored pods -- that represented a significant part of its business -- in October, and pulled mint flavors in November. The WSJ report suggests that meeting at this point represents a compromise between the Trump administration and the tobacco industry, avoiding a wider ban on all flavored vapes -- that had been suggested -- ahead of the 2020 election. It would also avoid banning flavors in "open-tank" systems that allow people to mix their own flavors.
FDA issues its first approval for an Ebola vaccine
A month ago the European Union issued marketing authorization for a vaccine to prevent the Ebola virus in adults, and now the FDA has approved it. While noting that Ebola cases in the US have been very rare, director of the FDA's Center for Biologics Evaluation and Research Peter Marks said in a statement that "Vaccination is essential to help prevent outbreaks and to stop the Ebola virus from spreading when outbreaks do occur." Studies supporting its approval included one with 900 subjects in Canada, Spain and the U.S., where antibody responses matched with those seen elsewhere. Side effects included "pain, swelling and redness at the injection site, as well as headache, fever, joint and muscle aches and fatigue." An ongoing outbreak of Ebola in the Congo has killed more than 2,000 people, and more than 200,000 people have received the vaccine. A study during an outbreak in Guinea " determined to be 100% effective in preventing Ebola cases with symptom onset greater than 10 days after vaccination." The EU marketing approval precedes increased manufacturing of the dose, called V920, in Germany later in 2020.
The FDA is fast-tracking an algorithm that screens for heart failure
Today, the FDA granted "breakthrough status" to an algorithm that could make screening for heart failure more accessible -- both in traditional clinics and telehealth settings. The algorithm uses a deep neural network developed by digital health company Eko and Mayo Clinic. With as little as 15 seconds of electrocardiogram (ECG) data, it can identify Left Ventricular Ejection Fraction (LVEF), a measure that's commonly used to diagnose patients with heart failure.
FDA clears an interoperable, automated insulin pump
It might soon be decidedly easier for Americans to manage diabetes -- the FDA has approved the sale of an interoperable, automated insulin pump for the first time. Tandem Diabetes Care's updated t:slim X2 can pair with a Dexcom G6 glucose monitor to dynamically adjust your insulin levels and keep you in a safe glucose range for longer. It can accommodate exercise and sleep, and the Dexcom tie-in spares you from having to stick your finger when you're either dosing yourself at meal time or calibrating.
In-brain electrodes are the latest weapon against opioid addiction
Researchers at the West Virginia University Rockefeller Neuroscience Institute (RNI) and West Virginia University Medicine are conducting the first clinical trial in the US that uses deep brain stimulation to treat opioid addiction. The procedure is meant for those who have exhausted all other forms of treatment but still suffer from opioid use disorder. The first patient, a 33-year-old man, has a decade-long history of opioid and benzo abuse, overdoses and relapses.
Vape brand Juul is reportedly at the center of a criminal probe
E-cigarette maker Juul is in trouble again. According to The Wall Street Journal, people familiar with the matter say that the company is the subject of a criminal investigation by federal prosecutors in California. It's not yet been revealed what the focus of the investigation is, although sources say it's still in its early stages.
The FDA has opened a criminal investigation into vaping
The Food and Drug Administration opened a criminal investigation into the vaping supply chain earlier this summer, it has emerged. The Office of Criminal Investigations started the probe following reports of a vaping-related lung illness. The agency now says more than 530 people have been affected, and seven deaths have been attributed to the illness thus far.
The Trump administration plans to ban flavored e-cigs to curb teen vaping
The Trump administration announced today that it may ban the sale of most flavored e-cigarettes in an attempt to curb teen vaping, The New York Times reports. In a press release, the Department of Health and Human Services (HHS) shared that the FDA plans to finalize a policy to remove most non-tobacco-flavored e-cigs from the market. The FDA is expected to share specifics on the plan in the coming weeks.
FDA criticizes Juul for telling students its e-cigs are ‘totally safe’
In a letter published today, the US Food and Drug Administration criticized Juul for telling students that its vaping products are "totally safe" and "99% safer than cigarettes." According to the letter, Juul portrayed its products as "modified risk tobacco products." That is, Juul presented its vaping products as having "a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products." Such claims can only be made with FDA approval, which Juul did not have.
CDC warns against vaping until it figures out what’s making people sick
Until the Center for Disease Control can figure out what's causing the mysterious lung illness associated with vaping, it's cautioning people against e-cigs. Last week, it launched a joint investigation with the Food and Drug Administration into a respiratory illness reported after vaping. At the time, it said 215 possible cases had been reported from 25 states, and at least two deaths have been documented. "While this investigation is ongoing, people should consider not using e-cigarette products," the CDC wrote in a press release today.
FDA targets teens with e-cigarette prevention ads
Today, the FDA launched its first e-cigarette prevention TV ads. Part of "The Real Cost" campaign, they're meant to educate teens on the dangers of e-cigarette use. The ads will target nearly 10.7 million teens, aged 12 to 17, who have used e-cigarettes or are open to trying them. The short clips feature street magician Julius Dein, who turns a vape pen into a cigarette before onlookers. The trick is supposed to highlight the fact that teens who vape are more likely to start smoking cigarettes.
San Francisco set to become first US city to ban e-cigarettes
San Francisco has edged towards becoming the first US city to ban sales of e-cigarettes, as well as the manufacturing and distribution of them on city property. A preliminary vote saw city supervisors unanimously approve a ban on e-cigarettes the Food and Drug Administration has yet to review. It hasn't assessed any yet and companies have until 2021 to apply for reviews of their products under the agency's draft guidelines.
Social media ads for vaping must include nicotine warnings, FTC says
The Federal Trade Commission (FTC) and US Food and Drug Administration (FDA) warned a handful of "e-liquid," or vape, companies that they -- and their social media influencers -- must follow the same advertising rules as everyone else. Specifically, ads for vaping products that contain nicotine must include warning labels, as nicotine is an addictive chemical. The FTC and FDA issued letters to four companies stating that posts made by social media influencers must include those same warnings.
Parents may be able to spot ear infections with a paper cone and an app
Researchers are working on a smartphone app that could help diagnose ear infections. As NPR reports, the app uses the phone's microphone, its speaker and a small paper cone. In its current form, the app sends short, sound pulses through a funnel and into the ear canal. It then measures the echo of that sound, and an algorithm uses the reading to predict if there's fluid behind the eardrum, one of the common symptoms of infection.
