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Biotech Input Devices Hardware

Embedded Linux On a Digital Stethoscope 111

Posted by timothy from the bump-a-bump-a-bump-a-bump dept.
An anonymous reader writes "A team of electrical and computer engineering students at Calvin College is designing a digital electronic stethoscope running uClinux as its operating system. While there are many embedded devices built on Linux operating systems, medical devices running open-source software are extremely rare because of the perceived difficulty in obtaining FDA validation. The device is in its early stages of development, but major hardware choices have been made, and the team has recently released a Project Proposal and Feasibility Study."
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Embedded Linux On a Digital Stethoscope More

Embedded Linux On a Digital Stethoscope

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  • Why? (Score:4, Insightful)

    by KC1P ( 907742 ) on Wednesday December 26, 2007 @03:18AM (#21819792) Homepage
    OK I'll bite. Why does a stethoscope need an OS in the first place? How much file I/O, multitasking, networking etc. does a single-purpose device like this really do?
    • Dang, in-a-rush first-poster: RTFA! Happy holidays. ; )

      • Re: (Score:1)

        by KC1P ( 907742 )
        Being a USB target doesn't require an OS. And writing one file at a time on (I suppose) a FAT flash ROM doesn't either. Heck, the FTDI Vinculum microcontrollers run a USB *host* and FAT driver w/o needing Linux. I just think everyone's too quick to cram megabytes of code into (what should be) trivial devices, just because they want to build the same nest they've always lived in. Well sure Linux is still better than WinCE.
        • well, they're students, so it's unlikely they have a wealth of experience to draw from and know what will work before even beginning. and (this is my assumption) it looks like the device would not normally be connected to a USB port, but be standalone. i can't see how it'd be useful as a stethoscope, otherwise. walk around, collect and tag data, and download it to a PC later for analysis.

    • Re: (Score:2)

      by RuBLed ( 995686 )
      I agree and considering the trend, this part of the medical process would soon be done by robots. For most of us, the annual medical checkup (stethoscope part) is the only time we get touched by the opposite sex (hopefully)... This is truly a sad day in history...

      On the other side, having a historical record of your heartbeat / breathing (lung) sound could help in some medical cases...
    • well, basically, some script kiddies (sr. engineering design team) are hooking up a stream ripper to a pair of Bose noise-reduction headphones. so not a whole lot, really. but it mostly comes down to not reinventing the wheel.

      put another way, let's say their project was to build an amplifier. in theory, they could design the whole thing with discrete components. but in reality, using an off-the-shelf op-amp in the design will yield better results than they could ever achieve.

      • put another way, let's say their project was to build an amplifier. in theory, they could design the whole thing with discrete components. but in reality, using an off-the-shelf op-amp in the design will yield better results than they could ever achieve.

        But one method will teach you about the basics of amplifier design, the other will teach you how to click the buy button on amazon or whatever.

        The reason these people have chosen Linux is that they can strip out as much as possible that they do not need and have a fairly small kernel. Then they can still write some code that does everything they need to for their project on another linux box and cross-compile it for the tiny kernel they created earlier.

    • because maybe this is how the project started: -Lets make some kind of embedded device with linux -Lets use uClinux -Maybe a stethoscope? Yesss!

    • Re: (Score:1)

      by Teisei ( 1172661 )
      It could run email server ?

    • Archiving, Comparing, etc. (Score:5, Insightful)

      by DrYak ( 748999 ) on Wednesday December 26, 2007 @08:50AM (#21820804) Homepage
      Disclaimer : I A A MD.

      Currently, any exam can be recorded, stored, shared with an expert for additional advices, compared for reference, you can build libraries for teaching or for personnal reference, you can reprocess these data off-line to "clean them", you can mine them to discover whatever interests you, you can reproduce that data using a different way to display it (using false color instead of greys to help visualise contrasts, or more complex math like using fast fourier to transform Doppler-echo noises into a nice colored graphic) etc...

      This include everything from the most high tech devices like 3D scanners, MRIs, etc. to the most simple technical examination (electrocardiograms) or even the most trivial step in examination : overall visual aspect (digital photo cameras are a very valuable tool in several arrays of medicine including dermatology and surgery).

      And with all this digitalised information, you can even throw computer at the task of helping the clinicians. MRIs comes easily as an example where computer may help making something useful out of the data. But even much simpler exams like electro cardiogramme nowadays include small embed chip that can automatically recognise a couple of pathologies. Most modern machine will print in nice small message like "90% suspicion of grade I atrio-ventricular blocking", in addition of the actual tracks.
      (And in fact modern defibrillator heavily rely on on-board electronic intelligence. The iron-like you still see in movies aren't used that much. The modern ones are semi automatic : you stick two big electrodes on the front and side of the chest. the machine goes automatically an ECG, decide the procedure to follow, and announce on a small embed screen and using voice. The practitioner only has to push a button to confirm and do the shock if he agrees with the machine's conclusions. Everything is automatic and comes with voice instruction so even untrained personal could use it).

      Everything recordable and digitilized ? No. Nearly everything.
      The century old stethoscope isn't. You use it, you hear something, but you can't share it or store it for further reference.
      Meanwhile, there's a lot of information that trained doctor can hear in the stethoscope.
      But it's hard to show to other (you can store it in a library to keep it for a lecture, you can't point it with a finger on the graph to a student), the student need luck to be around when there's something interesting for her/him to hear. It can't be reproduced.
      It's almost some kind of voodoo art, where you have a couple of old expert who can diagnose almost anything with a simple stethoscope and by looking how the patient walk to enter the room. But they can't easily transmit their art. Sometimes you just wish you could keep them stored in formaldehyde.

      This gadget that those engineer are working on is a nice alternative to the formaline. A simple gadget that'll help store, archive, send, etc. the noises you may encounter when examining with a stethoscope.

      Also, I happen to be a little bit hard hearing. Not much. I doesn't pose any problem in normal life (I can enjoy classical music concerts for example). But when it comes to hearth noises, I start to show my limits and I suck with a stethoscope.
      Such a device could enable me to obtain better (cleaned of noise) signal. Or even, as the devices use apparently open source software (uCLinux), it won't be too difficult to bolt in some crypto+network capability and display a visual representation of the sound on my Palm's screen.

      I really think that throwing some electronics inside the stethoscope was long due, and I'm happy that the problem is currently being tackled with open source software.

      • Re: (Score:2)

        by necro81 ( 917438 )
        Digital stethoscopes have been around for a while, and I don't think anyone is questioning the value of being able to record heart sounds for later re-examination, training, etc. The main question is: being such a simple device (recording audio, transferring it to a computer later), why put an OS on it at all? You could do the same with a $.50, 8-bit microcontroller and a bit of C - no OS needed.
        • I know, totally dude! I just made one this morning for fun. God, what the fuck are these people thinking? IDIOTS! Its not like they gave it more than 2 minutes thought while perusing a website. If they had, they could have spent that two minutes making the damn thing like I did. Don't worry, I'll be posting all source code later today and we can get this baby into the hands of all the biohackers who need it!
        • Digital stethoscopes have been around for a while, and I don't think anyone is questioning the value of being able to record heart sounds for later re-examination, training, etc. The main question is: being such a simple device (recording audio, transferring it to a computer later), why put an OS on it at all? You could do the same with a $.50, 8-bit microcontroller and a bit of C - no OS needed.

          Until, like the GP suggested, you want to run a network stack and encrypt the traffic. Or compile fftw or some

          • Re: (Score:2)

            by nmos ( 25822 )
            Until, like the GP suggested, you want to run a network stack and encrypt the traffic. Or compile fftw or some other common open source numerical package for filtering out noise or doing other useful things.

            And cramming all of this onto the stethoscope rather than on a PC is better because???
            • And cramming all of this onto the stethoscope rather than on a PC is better because???

              Maybe doctors want to wear stethoscopes instead of PCs around their necks?
              • It would be nice to hear , and have the analysis of the arrhythmia so that you could adjust the patients medications. E.G. a patient with congestive heart failure has some symptoms (subtle), and has a slight heart sound that might not be heard with a normal 'scope. Computer analysis might hear some lung crackles - indicating excess fluid, and an increase in the patient's diuretics would help them out.

                However, a caveat, most diagnoses come from the history. Maybe 5% of the time does physical exam finding
                • Ah, for situations such as this we've got a new gadget called a connecting cable.

                  Shove some memory into the stethoscope and have it able to record what's going on. Alternatively upgrade all the bed-head stations whereby the patient's interactive screen doubles up as a medical computer (I've seen these used in places around the UK, but can't remember the brand name. Quite cool though) and include a USB port for a specialised external microphone (Think ultrasound scanner, but with the cold metal bit). That wa
        • How about a digital stethoscope you can hook to a generic flat screen color LCD for data analysis? tick!lock

        • The main question is: being such a simple device (recording audio, transferring it to a computer later), why put an OS on it at all? You could do the same with a $.50, 8-bit microcontroller and a bit of C - no OS needed.

          Oh ! You meant why *this particular* electronic-stethoscope project chose *a full uCLinux* as its particular software ?
          If you need to ask such a question, I think your geek is at risk of being revoked here around at /.
          Now, if you don't mind I'll go back at "Beowulf cluster of Linux-running t

        • Digital stethoscopes have been around for a while, and I don't think anyone is questioning the value of being able to record heart sounds for later re-examination, training, etc. The main question is: being such a simple device (recording audio, transferring it to a computer later), why put an OS on it at all? You could do the same with a $.50, 8-bit microcontroller and a bit of C - no OS needed.

          well, OK, as a former student myself that went through a sr. design project, i'll give my own perspective. one

      • Re: (Score:2)

        by zrq ( 794138 )

        .... I start to show my limits and I suck with a stethoscope.
        Did you really mean to say that ?

      • Re: (Score:2)

        by iabervon ( 1971 )
        On the other hand, a stethoscope isn't like an ultrasound machine, where you've got a lot of things you can control in the process. It seems to me that a USB digital stethoscope, which you could plug into whatever other piece of equipment you're using, or into the computer you're taking notes on, would be more valuable than yet another device that you interact with separately.

        And, of course, once the data has been captured by whatever primary piece of equipment you're using, it can analyze it in software re

        • On the other hand, a stethoscope isn't like an ultrasound machine, where you've got a lot of things you can control in the process.

          Thus it may be useful to have a small MP3-player sized (and functionally not much different anyway) smart device that can fill in your pocket instead of needing to connect a dumb device to a PDA or a PC.
          Use the device as a regular stethoscope most of the time and only plug to a Palm or a PC/Mac desktop whenever you need it (for more complex processing or visualisation, and to of

      • Thanks for the exposition, doc. Is there a body of knowledge at this time that interprets heart sounds by doing signal processing deeper than the traditional EKG trace? Can you actually draw conclusions about a heart by looking at, say, an FFT of the sound?

        rj
        • Organic signature analysis. Yes, that's been going on for a long time in a number of different medical fields.
    • Maybe to issue the occasional "kill" command?

    • Re: (Score:2)

      by PPH ( 736903 )
      Store a few MP3s for slow times in the ER?

  • Now, a REAL feat would be... (Score:3, Funny)

    by ThePromenader ( 878501 ) on Wednesday December 26, 2007 @03:19AM (#21819800) Homepage Journal
    ...installing Windows Vista on the aforementioned stethescope. Would there be room enough for McAffee?
  • I can't see this going very far. What doctor will wrap that thing around his neck? Unless, of course, it also plays MP3 files.

    There may be, however, a solution looking for a problem in the fact that the audio can be recorded for playback later. However, I can see a situation where a doctor is sued for malpractice, and the audio is used against him rather than for him in the case. I'd be rather wary of using this machine, based on those grounds alone.
    • It could also be used in his defence as well.

      simple example - patient see's doctor, walks out has heart attack, sues doctor claiming he should have diagnosed him, doctor plays back perfectly normal sounding heart beat. that kind of thing really comes down to how confident you are of your abilities...

      • The problem is, that heartbeats can be used to _find_ illnesses, but not to disprove them. So in no case will a heartbeat prove that a patient was healthy, yet, a heartbeat can prove that a patient was sick. To prove that a patient is healthy, a whole battery of other tests need to be made. Therefore, this could only be used as evidence _against_ the doctor.

        Note: I am a medic, not a doctor, so if I'm wrong please correct me.
        • You're wrong.

        • Re: (Score:2, Insightful)

          by timmarhy ( 659436 )
          well, i can't say i agree with you because erratic or racing heart beats are a vital clue to many illnesses.

          my partner's rapid heart beat was what lead to her being diagnosed with a certain illness. a doctor could very well play back the beats to show there was no reasonable way for him to know a person had a certain illness that related to it.

          • That's just my point. If the patient _has_ something, then the audio recording can prove that the doctor missed it. However, if the audio recording doesn't show anything unusual, the doctor _still_ should have performed other checks and not have relied upon the heartbeat alone.
  • I think if I was doing this, I would have started with rockbox [rockbox.org] - it already has all the audio playback and recording, runs on cheap, easily portable hardware (MP3 players). I'm assuming you only need 2 channels of audio input - otherwise you might have some extra hardware hacking to do. The only tricky bit would be the noise cancelling I don't know how much processing that takes.

  • limited clinical usefullness (Score:5, Informative)

    by ericcantona ( 858624 ) on Wednesday December 26, 2007 @04:28AM (#21819994)

    littmann [3m.com] make a variety of stethoscopes including digital ones, and have done for some time.

    However, dont believe the hype. They are of very limited clinical value. No hospital cardiology diagnosis these days would be based on auscultation. (echocardiography [wikipedia.org] would be used). For taking BP the traditional tube plus ear-pieces 'scope more than suffices.

    • Re: (Score:3, Insightful)

      by RattFink ( 93631 )

      They are of very limited clinical value. No hospital cardiology diagnosis these days would be based on auscultation.

      Stethoscopes either traditional or digital really aren't designed to diagnose anything in a clinic setting at least not where more accurate tests are availible. But that doesn't mean that they don't save a heck of a lot of time determining what to test for. Not to mention you seem to ignore areas of medicine such gastroenterology, pulmonology and emergency medicine.

      • 'Determining what to test for' is diagnosis

        In gastroenterology the only use of a stethoscope would be to listen for bowel sounds (increased if there is obstruction). This does not need any great audio resolving power. In 'pulmonology', i.e., respiratory medicine, bedside diagnosis with a 'scope is a thing of the past. V/Q scanning, VO2 testing, bronchoscoping, or even simple CXR are what lead to diagnosis. In emergency medicine I can't think of any situation where a stethoscope would be useful (other than

        • Re: (Score:1)

          by aukset ( 889860 )

          In emergency medicine I can't think of any situation where a stethoscope would be useful

          Assessment of any patient in an emergency setting starts with the ABCs, and you can't assess breathing without listening. Auscultation of breath sounds can reveal a lot about a patient's airway and breathing status, and it takes less than 10 seconds to do. Also, you cannot always get and don't always want to rely on an automatic BP, but then nurses do that. You don't seem to have a very deep understanding of how emerg

          • I think the parent was talking about the increased resolution that is possible with digitally enhances stethoscopes. And I agree with him. From a cardiac standpoint, I get 95% of my diagnosis from history and EKG. Add echocardiography and some sort of nuclear stress test will get me up to virtually 100%.

            The only time that a stethoscope is of real use to me is in an ICU setting to sort out a post-infarction VSD vs. papillary muscle rupture. And, either way, no one will take an individual to the operating

            • completely agree.

              more formally, one way the 'usefullness' of a diagnostic test can be assessed is in terms of positive predictive value [wikipedia.org]. I suspect the ppv of electronic vs ordinary stethoscope would be very low

              Also, apocryphally, a poor stethoscope may be very helpful: in general practice if a murmur is loud enough for you to hear with a 'cheapo' stethoscope its probably serious enough for you to do something about it, if you can't hear it with a cheapo stethoscope you probably don't need to worry !

              • You don't even want to miss a benign (i.e. harmless murmur)!

                The echocardiogram to prove it was harmless will bring in $600 of revenue. :)

        • I know NOW that I definitely don't want to come into a hospital on your shift. You'd just have a long list of equipment and medical jargon buzzwords to hurl at me. In a situation where said equipment wasn't right on hand, calibrated, and power available to operate it, I'd be fucked.

          You really, REALLY need to get outta the healthcare industry. Maybe you can get shunted off to a job at the FDA as one of the people obstructing advances in Medical Device development. You could be one of the people with the
          • The fact of the matter is that in the E.R., the stethoscope has minimal use. No one in their right mind will not do a chest X-ray for someone presenting with shortness of breath. If they miss a tumor or miss-diagnose a pneumonia, their ass gets sued.

            Also, the history of the present illness is so important that it trumps just about everything else.

            I do agree that some tests are over-ordered, but it's not apparent that cutting down on tests will either improve mortality or decrease total costs to the health

            • I have to agree. Most US ERs have a RN doing triage in any situation besides disasters. (Which is funny to watch the poor internist to route people though a hospital during a drill, they don't know where to send people in a larger facility, 500+ beds, sometimes sending patients to rooms that do not exist.) The RN will take the major symptoms and cat1 the patient if there is any cause is tripped as defined by protocols. However, usually triage isn't as bad as people make it out to be, it is the hellhole afte

    • Re: (Score:2)

      by irtza ( 893217 )
      Well, you said what I was going to say + here is another one: http://www.thinklabsmedical.com/electronic-stethoscope/products/ [thinklabsmedical.com] The only time I can think of that a stethoscope has been used consistently and necessarily for the management of a patient is post intubation - for confirmation of tube placement. Other than that, I don't know anyone who wouldn't order a CXR for suspicion of pneumonia despite a "clear" chest. an echo for the heart, an obstructive series for abdominal distension. The real use of
      • I actually have a close friend who has a Littman digital stethoscope. He got it during a cardiology fellowship and used it (with some fanfare) for a couple months. Then he suddenly stopped using it. It turned out that one night while he was on call the battery died and he didn't have a replacement and had to use a standard stethoscope. He realized that he really wasn't getting anything extra from the digital one and it was an extra thing that could fail on him during an emergency.

        That being said, I've h

    • Re: (Score:1, Insightful)

      by Anonymous Coward
      The main clinical utility I see for electronic stethoscopes is teaching - I've heard some great murmurs, added sounds, rubs, etc and not had any medical students to share it with. I know that getting competent at cardiac and even respiratory auscultation would have been faster for me with recordings of pathology to teach with. From my observations, uptake of electronic stethoscopes has been minimal though - I think I've only seen one or two people using them.

      The comments seem to be very 'everyone just uses
      • Thank goodness, someone with some sense. British Cardiology still very much relies on auscultation by an experienced clinician. Anyone requesting an echo or chest X-ray without an indication from physical examination will find their request denied.

        I've personally picked up a number of minor heart defects - usually MR - on auscultation when assessing patients pre-operatively, which have then been confirmed by echo. We could echo everyone pre-op but that would be a poor use of resources.

        I'm not sure of t
    • Cardiac issues and taking blood pressures are not the only areas where stethoscopes are used.
      Auscultations to listen to breath sounds for instance, how about that? Saying its not useful because its not perfect is silly - lets say you are examining a patient and have suspicions of a respiratory disease / cardiac issue / ... - if you get a clear sound you will both have a higher sensitivity and a higher specificity. Yes, a more accurate procedure will confirm that but an initial diagnosis is valuable too beca
  • If it has an OS can it run other applications? like for playing mp3s?

    Doctor: Oh my, you seem to have arrhythmia!
    Patient:?!?!
    Doctor: Oh sorry i forgot to turn off the mp3 player, that was just a Murcof track, my bad.

  • Electronic stethoscopes (Score:1, Informative)

    by Anonymous Coward
    has been done, although without Linux, but thats made up for with some SW patents.
    http://www.medicom.bang-olufsen.com/sw435.asp [bang-olufsen.com]
    The problem is that the sound quality is too good for conservative doctors, so they had to make a function that imitates the sound from an old tube stethoscope.
  • the look on someone's face when the thing locks up while in use. Either this man is dead or my linux driven digital stethoscope needs a reboot.

  • I really hope this fails approvals (Score:3, Interesting)

    by petes_PoV ( 912422 ) on Wednesday December 26, 2007 @06:02AM (#21820242)
    not because it doesn't work, but simply because it's such a dumb idea.
    OK, I realise that most of the other replies are critical, too

    Really this is just using tech. for it's own sake - and introducing a whole bunch of unnecessary problems into what is really a very simple procedure. Instead of a simple piece of rubber tube, with a "thingy" at each end you are now reliant on an embedded device with it's own power requirements, a link to a host PC with software compatability and yet more power requirements and finally the doctor or nurse wears a headphone to listen to exactly the same sounds they'd hear through a conventional stethoscope.

    there is a slight glimmer of hope for this: remove the doctor.
    If you can possibly make this device totally idiot-proof and throwaway cheap, it might just find a use for remote diagnostics, where a patient can self-monitor, upload their "swooshing" noises to an AI which does most of the work.
    Of course this presuposes that the patient isn't too busy having a heart attack, and can get their PC connected up to the net, and the battery in the device hasn't gone flat, and the AI at the other end is working, and someone can take the necessary action (if needed).

    On second thoughts, scrub the glimmer of hope. There are just too many things can go wrong

    • Telemedicine is a rising field. If this instrument can be used to record and upload diagnostic information, it will be of use. It doesn't need to be an AI at the other end of the remote connection, simply an expert specialist to listen. There are many remote or rural areas of the world where experts do not reside. In a networked world a device like this will allow rapid remote diagnosis. Not every local clinic is equipped with a cluster of the latest buzzword-compliant diagnostic equipment.

    • Think about a patient in a rural hospital. If they are lucky, there is an experianced physician on-call, but more likely they have an RN or LPN to deal with. A nurse or technician could record the sound and send it for a "wet read" to a remote physician. This is the model used by tele-radiology currently. Then a local physican could make a "dry read" in the morning. In a place with only a couple of physicians in the local area, such technologies would be invaluable.

  • huh? (Score:1)

    by nguy ( 1207026 )
    medical devices running open-source software are extremely rare because of the perceived difficulty in obtaining FDA validation

    Do you have any pointers to actual decision makers talking about this "perceived difficulty"?

    And why would anybody think anyway that open source software should have a harder time getting approved than closed source software?
    • When a development team adopts a proprietary solution, i.e. VxWorks, there is already a lot of validation that has been performed. With an open source solution, the entire body of code would need to be thoroughly audited and qualified. This would be fine, but somebody needs to spend the big bucks getting this accomplished. Afterwards, a specific frozen snapshot of the code will be easier to qualify for future projects/products. However, your organization has now spent a whole bunch of money qualifying a

      • Re: (Score:1)

        by nguy ( 1207026 )
        With an open source solution, the entire body of code would need to be thoroughly audited and qualified

        In principle, open source code needs to be revalidated no more and no less between changes than closed source. The difference is that with closed source code, manufacturers never find out about a lot of changes or bugs, so they can pretend they don't have to validate the code or worry about those bugs.

        Hopefully, the courts will sooner or later realize that this use of closed source is not just irresponsib

    • Re: (Score:2)

      by HuguesT ( 84078 )
      Hello,

      I've been involved in the design and implementation of a few medical and bio-medical instruments.

      All software used in medical instruments submitted to the FDA, whether commercial-off-the-shelf (COTS), OSS, proprietary or otherwise must be validated for use in the instrument. This usually includes extensive documented testing.

      COTS software is usually considered easier to validate for a variety of reasons : if it is a largely used piece of software (say Excel), it is likely its usage in other medical in

      • Re: (Score:2)

        by sm62704 ( 957197 )
        COTS software is usually considered easier to validate for a variety of reasons : if it is a largely used piece of software (say Excel), it is likely its usage in other medical instruments has been validated [joelonsoftware.com] before.

        By now you've probably seen a lot of the brouhaha over a bug in the newest version of Excel, 2007. Basically, multiplying 77.1*850, which should give you 65,535, was actually displaying 100,000.

        Yeah, great reason to use closed source...

      • Re: (Score:1)

        by nguy ( 1207026 )
        In contrast, OSS varies a lot and often.

        Quite to the contrary: OSS comes with complete, auditable changelogs, cryptographic checksums, full bug databases, and published, down-to-the second correspondences between releases and source code. Almost no commercial vendor (certainly not Microsoft) gives you that level of information and detail.

        There are only "fewer versions" of software like Excel because commercial companies often patch software without changing the version number, and because they leave many k

        • Re: (Score:2)

          by HuguesT ( 84078 )
          I see I'm not getting through, must be me.

          I said I had been involved with designing medical and bio-medical instruments, I didn't say I made the rules, nor did I say I approved of them. Talk about jumping the gun.

          For the record, I publish OSS and I'm not with a company. I merely explain why OSS is not popular with medical instrument designers: it makes more work for them. The onus is generally on the user to prove OSS suitable for their instrument, whereas for COTS this is not quite the case.

          Some software h
  • They are using a 32bit micro, running on batteries, running linux. It is not a low power micro, and if similar choices were made elsewhere, this thing would need a back pack power supply to be able to run for any extended period of time. They are using embedded linux. So, they really don't know what they are doing with the micro, and will just try different software out to see what works. Fancy system graphs.. just foolin people to think they know what they are doing. But, its probably good for a bit of fun
  • FDA approval should not be a problem for a stethoscope. It is not a food and not a drug and not a mission/life critical device. Do stethoscopes need any certification whatsoever? They might get an endorsement from a prominent cardiologist or a cardiology group/association/college/council but given the existence of _CHEAP_ disposable stethoscopes that barely work, I can't believe that there is any requirement for durability, reliability, or sound quality for stethoscopes.
    • Oh, come on, now. Tongue depressors need certification. This device uses Software, for gods sake. There will be a whole pack of 'Regulatory Affairs' people all over the project, like mud on my boots after taking our britanny out to the field on a rainy day.

      There are three main classes of medical devices, ranging from bedpans to implantable pacemakers/defibrillators. All devices introduced to the market require regulatory oversight and qualification.

      To be frank, the medical device industry has it all sew

  • This could become useful (Score:3, Informative)

    by Secrity ( 742221 ) on Wednesday December 26, 2007 @07:32AM (#21820480)
    There are electronic stethoscopes available, but they are expensive and noisy. The ability to electronically produce a clean sound from a stethoscope would have some niche uses, primarily in the educational area. It would be nice to be able to allow a gaggle of interns to hear a patient's heart rather than to have each of them have to listen individually with their own stethoscope. I wonder if the designers have included Bluetooth in the original design. As was already mentioned there may be pros and cons to recording stethoscope sounds; I tend to believe that recording the sounds would become desirable for some doctors. Doctors tend to record and document everything as it is, and this could make it practical to record stethoscope sounds, Yeah, the prototype may be big, heavy, and a battery pig; that means that there are many opportunities to reduce its size, weight, and power consumption.

    Although the original design does not include waveform diagnostics, analysis, and display capability, that could be added later at little cost.
  • why? I mean, why can't this be done with a microcontroller and a DSP?. Or a "DSC" (Digital Signal Controller) such as Microchip's DSPic (DSPs with an embedded microcontroller -- or vice versa). They have a lot of pins, a lot of processing power... they even have USB and all. Why do we need to run Linux everywhere? Have we lost the point of using an Operating System?
    Quote from Wikipedia [wikipedia.org]:

    An operating system (OS) is the software that manages the sharing of the resources of a computer and provides programmers

  • Thank God the new stethoscope runs on Linux. Who knows what risks for the patient (viruses, worms, etc.) if it ran Windows Embedded... :D
  • I'm a network admin at a little rural hospital which is not the cutting edge of medical technology. And yet I sit a few feet from half a dozen Linux servers. And there are several more embedded ones used by clinical people--e.g., our bone density imager is Linux.


    There are certainly more windows-based diagnostic devices than other OSes, but I would hardly call Linux "rare" out on the floor.

    • This is certainly encouraging news. Is there some way we could get documented evidence of these FDA validated embedded systems? Not that I don't believe you, but a comment on Slashdot doesn't exactly stand up as a credible source in an academic setting. Documented examples would help our cause against our sometimes skeptical professors :-).

      If you can give us any info, reply to this post or contact us using the email address on our contact page [calvin.edu].

      - David
      [ Rhythm Reloaded ]
      http://www.rhythmreloaded.c [rhythmreloaded.com]

  • bs statement in article (Score:2, Insightful)

    by Anonymous Coward
    " ... medical devices running open-source software are extremely rare because of the perceived difficulty in obtaining FDA validation ..."

    That is totally inaccurate. There are plenty of medical devices in use running Linux, and they all get FDA approval without any issue. As long as you go through the same procedures in testing/quality-assurance and documentation it's all the same end result to the FDA. Even in the case of software which is complex relying on other pieces of software, black box testing solv

  • Open source NOT a problem for FDA (Score:3, Informative)

    by div_2n ( 525075 ) on Wednesday December 26, 2007 @10:39AM (#21821428)
    I work for a manufacturer in the pharmaceutical industry and I hear people say things like Linux and/or Open Source is a problem with the FDA, but I haven't seen anything yet to back that up. Period.

    To "validate" software with the FDA, you really only need to do three things:

    1) Make your software/system/device secure
    2) Have control over the system
    3) Document #1 and #2

    There are people who come from an old guard that have all sorts of misconceptions about what can and can't pass FDA regulations. It seems to stem from a gross misunderstanding of what the regulations actually say.

    I've read the portions that deal with computers and electronic information. There is absolutely nothing in it to suggest open source even remotely is an issue. I suspect this is an urban legend started by companies selling proprietary software.

    Regardless, the regulations (Part 11) are the FDA Bible and so long as you can satisfy the requirements in them which basically boil down to the three I listed above, then you are in compliance.

    To convince yourself this is true, read this. [fda.gov]
    • We on [ Rhythm Reloaded ] tend to agree with this analysis, and that is the position we have taken in our PPFS. However, it would still be nice to have a documented example of an embedded medical device using open-source software passing FDA validation. It seems that most of the work in this area has been done with non-embedded systems that do not come into contact with patients (such as patient databases and the like).

      If anyone has a concrete example they could give, we would appreciate it. Reply to t
  • So does it run Linux?
  • that has to be one of the coolest headlines ever.
  • The ultimate advance in stethoscopes would be one with an integrated Peltier cooler. That way, doctors wouldn't have to store them in the freezer between uses.
  • "...medical devices running open-source software are extremely rare because of the perceived difficulty in obtaining FDA validation."

    Horseapples! I've worked in this industry and that is most certainly not the answer. The reason you don't hear more about Linux devices in the medical field is one of two reasons: 1) The high demand for real time systems, which Linux hasn't been that great at historically; and 2) They're not telling you about it! I've worked in the field developing system software, and not onc

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