FDA, ICS-CERT issue warnings for medical device, hospital network security

Reports that medical devices implanted in patients or used for their treatment may have dangerous vulnerabilities are not new, but a new “safety communication” is focusing more attention on the issue. Ars Technica points out that the Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) group that works along with private industry to protect the nation’s infrastructure issued its own alert alongside the FDA’s, focusing on the many embedded devices that are protected only by hard-coded passwords.

The ICS-CERT message recommends restricting physical access to sensitive hardware, improved designs that are more resistant to potential attacks and increased network security. The FDA lists various vulnerabilities it’s become aware of like network connected devices being infected by malware, mobile devices being targeted to access patient data, the previously mentioned hard-coded passwords issue and more. Going forward, the FDA is collecting reports of “adverse events” to determine if security has been compromised, and will issue new guidelines on mobile health technology later this year. We’ve seen examples of potential security solutions for pacemakers in the past, and the more connected healthcare devices become we’re sure patients expect any potential vulnerabilities to be addressed as well.

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Source: Ars Technica, FDA, ICS-CERT

Popular Surgical Robot Being Investigated By FDA As Incidents Increase

Popular Surgical Robot Being Investigated By FDA As Incidents Increase

The da Vinci surgical robot, developed by Intuitive Surgical, can now be found in a quarter of all hospitals in the country. So far it has been used to perform around 400,000 procedures. According to new report the FDA is now investigating this popular surgical robot as reports of incidents have increased over the past year, in which 500 incidents were reported, including several deaths. As of now there are no official results of this investigation.

The da Vinci robot is used in procedures such as repairing heart valves, removing prostates, wombs and gallbladders, organ transplants etc. A surgeon controls the robot by sitting in front of a screen instead of standing over a patient, making the procedure less tiring. Another advantage of the robot is that its hands don’t shake, though surgeons are hardly ever clumsy, still there’s a difference between man and machine. The same machine has caused problems, such as the incident when the robot’s arm wouldn’t release a tissue it grasped during the procedure. Such incidents could potentially be life threatening. This robot is the only robotic system that the FDA has approved for soft tissue surgery.

By Ubergizmo. Related articles: Cedars Sinai Hospital Announces BabyTime Initiative For Mothers To Interact Remotely With Their Newborn Baby, Panasonic DNA Testing Lab,

Breathometer lets phone users keep alcohol in check from a keychain (video)

Breathometer lets Android and iPhone users keep their alcohol in check from a keychain video

Who knew that smartphone owners were suddenly such temperate drinkers? Just days after Alcohoot unveiled its take on a phone-friendly breathalyzer, Breathometer is here with its own way to watch our tipsiness. The namesake, FDA-approved gadget will plug into the headphone jack of an Android or iOS device and warn if our blood is too alcohol-rich, all while staying small enough to fit on a keychain. Plans are underway to eventually let soused users hail a taxi from the native app. The Breathometer won’t be available until we’re at the height of summer party season, but it should be cheap enough to eliminate any excuses: its Indiegogo campaign is asking for just $20 to secure a Breathometer alongside a pledge, or less than a good night out.

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Source: Breathometer, Indiegogo

Your Google Searches Can Uncover Drug Side Effects Faster Than the FDA

The internet: it’s our teacher, our entertainer, and ever increasingly, our doctor. Every day, the country’s sniveling, coughing, light-headed festering contagions plop in front of their computers in hopes of figuring out what the hell is a matter with them—for free. So while brilliant, it’s not entirely surprising that scientists were, for the first time, able to find significant evidence of unreported prescription drug side effects faster than any of the FDA’s own methods. And as The New York Times reports, all thanks to our ailing internet search queries. More »

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.

RP-Vita

The robot stands approximately the height that a human would and has technology inside to allow it to self navigate. The technology is designed to support remote Doctor and patient consultations allowing the physician to be where he’s needed to be at the right time. The robot is packed with sensors allowing it to move around without bumping into people or other objects.

The system has an iPad interface that allows the doctor to communicate with staff and patients. With the FDA granting approval for the robot to be used in hospitals, it can now be used for active patient monitoring in pre-operative, peri-operative, and postsurgical settings. I wonder if this means on-call doctors might not have to rush back into the hospital when the phone rings if one of these robots is available.

The FDA approval includes clearances to work in the cardiovascular, neurological, prenatal, psychological, and critical care areas. The robot has an integrated monitor and web cam and allows the remotely operating physician to access patient information using Wi-Fi. It also has a built-in stethoscope allowing the doctor to perform ears on assessments from a distance. The robot is far from cheap with previous estimates that between $4000 and $6000 monthly to operate.

[via Science World Report]


FDA approves iRobot RP-VITA for use in hospitals is written by Shane McGlaun & originally posted on SlashGear.
© 2005 – 2012, SlashGear. All right reserved.

FDA Approves Robot Doctor

fda robot FDA Approves Robot DoctorThe FCC approves consumer electronics devices for the masses, but what about the FDA? Well, they make sure that all things medical are fit for public service, and the latest candidate to gain approval from this regulatory board is the first robot doctor developed by iRobot. Wait a minute here, doesn’t iRobot churn out Roombas? Yup, that is correct, and the robot doctor in question here is the RP-VITA that comes in the form of a telepresence robot. It will rely on a large display with an iPad interface to enable a doctor to examine a patient remotely, and it works swell in pre-op and post-op situations, not to mention during surgery as well.

This FDA clearance is significant, since it proves that a robot is able to move about safely and independently through a fast-paced, chaotic and demanding hospital , and would also mark a rather significant technological milestone for the robotics and healthcare industries.

The RP-VITA is currently on sale by InTouch Health, where it will fall under the guise of the company’s latest flagship remote presence device. iRobot has plans to explore adjacent market opportunities for similar robots, and we do wonder what other kinds of medical robots are on their way. Perhaps those in the operating theater that fixed up Darth Vader in his menacing suit? [Press Release]

By Ubergizmo. Related articles: Chitti Robot Monitors ICU Patients, Larry The Vomiting Robot,

Google adds medication to the Knowledge Graph, might ease our minds through search

Google adds medication to the Knowledge Graph, might save our health through search

It’s no secret that many of us turn to Google searches for medical advice, much to the chagrin of doctors who have to contend with periodic bad attempts at self-diagnosis. Google might not have a cure for hypochondriacs, but it can stop all of us from taking risks at the pharmacy: it’s adding medicine to the Knowledge Graph. Search for medication and the side results panel will bring up data from the Department of Veterans Affairs, the FDA and the National Library of Medicine. Apart from a very top-level summary of a drug’s role, the Knowledge Graph will show alternative names, related drugs and (most importantly) risks. The search firm is quick to warn that it’s not giving us a license to prescribe our own treatment — we’ll want to talk to someone who swore the Hippocratic Oath, if there’s more than a headache. The depth of Google’s new search tool could still do more to assuage worried patients than a pill bottle label.

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Source: Inside Search

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.


It could also end up being a big breakthrough for doctors and caregivers who previously didn’t have any control over whether or not their patients actually followed their instructions. The fact of the matter is that no one actually likes taking pills, and sometimes we choose to ignore instructions that tell us how much to take and when, precisely, to take it. It doesn’t take a rocket scientist to figure out that ignoring those instructions can lead to some pretty serious problems, so now doctors have a way of ensuring that their patients are doing what they should be.

Proteus says that the sensor can be “integrated into an inert pill or other ingested products, such as pharmaceuticals,” and is powered by those wonderful fluids you have sloshing around in your stomach. Once the sensor has been ingested, it sends a signal to a patch worn on the skin, telling it the exact time you took your medicine. That information is then relayed to a smartphone app, allowing caregivers to monitor your (hopefully stellar) medicine habits. Once the sensor has done its thing, it dissolves right there in your stomach. This all happens with the patient’s consent of course, so you don’t need to worry about someone sticking microchips in your pills without telling you (or do you?).

It sounds like a great idea in theory, but at the moment, there’s no word on when this technology will hit the market. Still, expect to hear more about this soon, as insurance companies will likely eat this technology up. After all, they’d raise your premiums in a heartbeat if they discovered you weren’t regularly taking your meds, so plan on this being a big hit with them.

[via Engadget]


FDA approves ‘ingestible sensor’ for use as a medical device is written by Eric Abent & originally posted on SlashGear.
© 2005 – 2012, SlashGear. All right reserved.


FDA approves Proteus Digital Health’s e-pills for dose monitoring

FDA approves Proteus Digital Health's e-pills for dose monitoring

An “ingestible sensor” doesn’t sound like the tastiest of snacks, but soon it might be just what the doctor ordered. A tiny microchip which activates upon contact with stomach acid has recently been given the green light by health regulatory agencies in the US and Europe. When the sensor is swallowed, an external patch picks up its signal and shoots a message over to whoever it’s supposed to. The technology is aimed at tackling an issue known in the healthcare biz as compliance — or, following instructions. Correct timing and dose are important for many drugs, and lax schedules can be responsible for treatment failures or the development of nasty drug-resistant bugs. Although the necessary trials used placebo pills, one pharmaceutical heavyweight has already bagged a license to the technology for real-world applications. If the thought of passing microchips is troubling you more than the thought of eating them, no need to worry — the kamikaze sensors dissolve in your stomach shortly after completing their mission.

Continue reading FDA approves Proteus Digital Health’s e-pills for dose monitoring

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FDA approves Proteus Digital Health’s e-pills for dose monitoring originally appeared on Engadget on Wed, 01 Aug 2012 17:04:00 EDT. Please see our terms for use of feeds.

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FDA Approves the First Smart Pills That Track When You’ve Taken Your Meds [Medication]

Remembering if you’ve taken your medication could be a thing of the past now that the FDA has approved Proteus Digital Health’s new chip-embedded pills that can report back to a sensor and your smartphone when meds have been ingested. More »