FDA

FDA warns biohackers over DIY gene therapy

FDA warns biohackers over DIY gene therapy

Biohackers were on the receiving end of an FDA warning this week, one that advised DIYers that publicly available gene therapy kits are illegal. Gene therapy is the process of using genetic material for manipulating or in some way modifying the expression of a gene. Brave -- or foolish, perhaps -- biohackers have taken to self-administering their own gene therapies, and the FDA isn't happy about it.

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FDA approval of Apple Watch medical accessory is world’s first

FDA approval of Apple Watch medical accessory is world’s first

An EKG reader by the name of KardiaBand is officially the first Apple Watch medical accessory to be approved by the FDA. This device works with the Apple Watch to detect abnormal heart rate. KardiaBand allows users to take a single 30 second EKG on their own wrist with a tap.

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FDA approves Abilify MyCite, a digital pill with a sensor that tracks doses

FDA approves Abilify MyCite, a digital pill with a sensor that tracks doses

The FDA has announced a new approval that marks a first for the agency: Abilify MyCite. This medication is described as a 'digital pill,' one that features both the medicine and an embedded sensor. Thanks to that sensor, patients and, more importantly, their doctors, are able to track when the medication has been taken. The pill works with a related wearable, but some worry about the privacy implications.

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FDA embraces vaping in surprise move against big tobacco

FDA embraces vaping in surprise move against big tobacco

After years of worry and doomsday conspiracy theories, the Federal & Drug Administration has just tossed a curveball into the tobacco industry, announcing plans to help support e-cigarettes and other 'innovations' that are less harmful than traditional cigarettes. The move aims to reduce the number of deaths and preventable diseases that arise from smoking tobacco, as well as curbing the use of cigarettes among teens.

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The first PrEP HIV generic just got FDA approval, and it could change lives

The first PrEP HIV generic just got FDA approval, and it could change lives

The US Food and Drug Administration (FDA) has approved a generic form of the drug Truvada, an antiretroviral and pre-exposure prophylaxis (PrEP) from Gilead Sciences. The approval notice was posted on the FDA's website yesterday; finer details, such as the cost associated with the generic (Emtricitabine and Tenofovir Disoproxil Fumarate tablets) is still unknown, though the price will no doubt go down. While the name-brand drug is blue in color, the generic version may arrive with a different design.

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As of today, e-cigarette makers must get FDA product approval

As of today, e-cigarette makers must get FDA product approval

The day some have feared and others have long awaited is finally here: the FDA’s e-cigarette regulations go into effect today, and they require retailers to, among other things, request identification from any prospective buyers who look like they may be younger than 27. The move aims to curb the ease by which minors have been able to acquire ‘vaping’ devices, and is joined by a ban on e-cigarette vending machines with the exception of facilities with access that has been restricted to adults only.

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FDA warns public about ‘cool trend’ whole body cryotherapy

FDA warns public about ‘cool trend’ whole body cryotherapy

Whole body cryotherapy is a growing trend amongst those brave enough to tackle the coldest (briefly) livable temperatures — if you’ve ever taken an ice bath, gone on a polar bear swim, or spent a few minutes running around in an ice chamber, you’ll probably be familiar with the general idea. Whole body cryotherapy is popping up at spas and wellness centers across the nation promising to help treat a whole host of ailments, including serious conditions like MS and Alzheimer’s disease. Finally, the FDA has stepped in with a word of caution.

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FDA approves home stomach pump to combat obesity

FDA approves home stomach pump to combat obesity

This week, the Food and Drug Administration announced its approval of a stomach-draining device called AspireAssist; it is designed to combat obesity via a drainage tube and port implanted in the patient’s stomach, allowing the patient to drain some of their stomach contents after they eat. When used properly, the device will drain about 30-percent of a meal's calories, according to the FDA, essentially serving as an alternative to lap band surgeries.

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FDA fires back at OIG over claims its food recall program is too slow

FDA fires back at OIG over claims its food recall program is too slow

On June 8, the Office of the Inspector General sent the FDA an ‘early alert’ letter advising it that an ongoing audit has found the Food and Drug Administration’s food recall program to be inadequate on a couple of levels, particularly when it comes to prodding companies to get a move with their voluntary food recalls. Now the FDA has fired back with its own statement, justifying its processes and saying that it expediting changes it already had in the pipeline.

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FDA guides makers on securing connected medical devices

FDA guides makers on securing connected medical devices

The FDA has released a draft guidance for companies that make connected medical devices, advising them of steps that should be taken to deal with cybersecurity risks. The guidance concerns medical devices that connect to a facility’s network, and comes at a time when an increasing number of companies — medical and otherwise — have been hit with massive data breaches.

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FDA on genetically-modified salmon: safe to eat, no labels needed

FDA on genetically-modified salmon: safe to eat, no labels needed

The FDA has approved genetically-modified salmon, making this the first time the agency has approved a GM animal for human consumption. The modified fish is “AquAdvantage salmon,” a type of Atlantic salmon that grows faster than regular non-GM salmon while consuming less food. Genetically-modified food has been the source of ample controversy, with some arguing that it is a threat to the environment, less healthy, and other alarmist claims.

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23andMe will resume (limited) testing for health issues

23andMe will resume (limited) testing for health issues

23andMe, the company that benefited greatly with some favor from Google, suffered a massive setback when the FDA stepped in and shutdown its genetic health screening service. At the time, users could pay $99 to spit in a vial and, some time later, access their genetic data parsed to include details about their personal health. Those details included things like risks for certain diseases and cancers, how they respond to different types of medication and diets, and more.

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