FDA

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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23andMe class action lawsuit claims misleading advertisements

23andMe class action lawsuit claims misleading advertisements

Taking a peek into our genes isn't something easily accomplished, and that is where the Google-backed 23andMe genetic testing service came in. For $99, anyone could send in their sample and receive the results a short while later. In recent days, the company was slapped with an order from the FDA to stop selling its kits, and a handful of days later, customers have filed a class-action lawsuit against the company.

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23andMe issues response following FDA warning and sales halt

23andMe issues response following FDA warning and sales halt

Earlier this week, the genetic testing company 23andMe was forced to stop selling its testing kit following an FDA decision that the kit is a medical device and requires regulatory approval. The decision was largely based on concern over inaccurate results, and led to a warning letter being published by the FDA. In response to the issue, 23andMe has published its own statement on the matter.

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Google-backed 23andMe genetic testing shuttered by FDA

Google-backed 23andMe genetic testing shuttered by FDA

DNA analysis company 23andMe has been forced to halt sales of its testing kit, after the FDA decided the saliva kit counted as a medical device and as such lacked the proper regulatory approval. The decision, which affects 23andMe's flagship "Personal Genome Service" (PGS) testing product, comes becomes the "FDA is concerned about the public health consequences of inaccurate results from the PGS device" the agency said in a warning letter, arguing that the company - which was co-founded by Anne Wojcicki, former partner of Google co-founder Sergey Brin - was putting customers' health at risk by potentially mis-diagnosing or overlooking actual medical concerns through its unapproved assessments.

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FDA approves iRobot RP-VITA for use in hospitals

FDA approves iRobot RP-VITA for use in hospitals

Last summer we mentioned that iRobot was conducting trials with the new telepresence robot called the RP-VITA. Today word has turned up that the FDA has approved that robot for use in hospitals within the United States. RP-VITA stands for Remote Presence Virtual Independent Telemedicine Assistant.

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FDA approves ‘ingestible sensor’ for use as a medical device

FDA approves ‘ingestible sensor’ for use as a medical device

Here's one that the conspiracy theorists among us will love: the FDA has approved an "ingestible sensor" made by Proteus Digital Health for marketing as a medical device. Though such a device sounds like it can't be anything other than devious, the idea behind it is quite simple, as it will be used to make sure that patients are taking their pills when they're supposed to. Apparently Proteus has been working with the FDA since 2008 to get this thing approved, so this could prove to be a pretty big breakthrough for the company.

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