FDA

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The FDA has released a draft guidance for companies that make connected medical devices, advising them of steps that should be taken to deal with cybersecurity risks.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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Ancestry in talks with FDA to launch medical DNA testing

Ancestry in talks with FDA to launch medical DNA testing

23andMe ran into trouble with the FDA over its DNA testing, which included results of a medical nature — info about disease risks and such. It ultimately had to shut that part of its service down, but another company may take over in its place. Ancestry.com is in talks with the FDA about launching a DNA testing kit that will be used to provide possible health information about a person — details about things like one’s reaction to medication and more based on their genetic details.

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BrainPort V100 allows the blind to see using their tongue

BrainPort V100 allows the blind to see using their tongue

A device that sounds very strange has won FDA approval to come to market. The device is called the BrainPort V100 and it is a sensory substitution device that is designed to give the blind vision of a sort. Seeing in this case is done via an electrode that stimulates the tongue of the user. The FDA cleared Wicab, the maker of the device, to bring it to market last week.

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What you need to know about the FDA Trans Fat ban

What you need to know about the FDA Trans Fat ban

The FDA is clamping down on trans fat, telling food companies that they must cut one of the most unhealthy from what they sell within three years. The decision marks the culmination of a lengthy Food and Drug Administration investigation into partially hydrogenated oils (PHOs), which are currently the primary dietary source of artificial trans fat in processed foods. The conclusion is damning: PHOs are considered not "generally recognized as safe" for use in human food, the FDA decided, and so they have to go.

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23andme wins FDA approval for genetic test kit

23andme wins FDA approval for genetic test kit

You might recognize the name 23andMe as the company that sold home genetic testing kits. Back in 2013, 23andme was all but shut down by the FDA when the FDA ruled that the company could no longer sell its genetic testing kits. In a big turnaround, the FDA has now granted approval to 23andme to sell a home genetic test kit for one specific rare genetic disease.

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VetiGel is a plant-based gel that can stop bleeding instantly

VetiGel is a plant-based gel that can stop bleeding instantly

When a massive injury occurs, and there’s bleeding involved, time is essential. Often times, emergency medical personnel are on-scene, but have little recourse to do more than get you somewhere else quickly. A place that has the equipment necessary to help you get through the trauma and (hopefully) live. A new syrum, named VetiGel, could change that. The plant-based material can be affixed to human tissue to stop bleeding rapidly. It’s not yet widely available, but is being trialled at veterinary clinics.

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HealthPatch MD wearable encrypts your data, gets FDA approval

HealthPatch MD wearable encrypts your data, gets FDA approval

Vital Connect's newest wearable, the HealthPatch MD, is a health-centric device different than most medical wearables we've seen. Unlike wristbands and such, the HealthPatch MD is targeted more towards doctors and newly-released patients, and as such it takes its job seriously: the device, among other things, encrypts the wearer's health data to HIPPA standards.

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ReWalk is the first FDA-approved personal exoskeleton

ReWalk is the first FDA-approved personal exoskeleton

If you're still not used to seeing electric wheelchairs, robotic prosthetics, and other forms of hi-tech assistive technology in public places, it would be best to catch up with the times as a new one just joined the list. The US Food and Drug Administration has just given the thumb up to the ReWalk Personal exoskeleton, paving the way for similar machines that will help those who have lost mobility to get back on their feet.

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Dean Kamen’s incredible robot arm is good to go

Dean Kamen’s incredible robot arm is good to go

Dean Kamen's robotic prosthetic limb, the DEKA Arm System, has been granted FDA approval, with the DARPA-sponsored project controlled by electrical signals from sensors where it meets the wearer's limb. Dubbed "Luke" - a reference to Luke Skywalker from the Star Wars universe - the arm is a huge step forward from existing mechanical prosthetics, allowing for more detailed uses like turning keys and pulling zippers.

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Cefaly headband gets FDA approval for migraine treatment

Cefaly headband gets FDA approval for migraine treatment

Researchers around the world are always looking for new devices and gadgets that will help keep people healthy. A new gadget called the Cefaly has been approved by the FDA for treatment of pain caused by migraine headaches. The gadget is a headband and can relieve pain without using medications.

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