FDA clears ‘world’s first’ portable, low-cost MRI

https://www.healthimaging.com/topics/healthcare-economics/fda-clear-worlds-first-portable-mri

by apsec112 • 6 years ago

447 130 6 years ago

ISL2• 6 years ago

From a quick survey of the article, it sounds like this instrument is likely to be using conventional electromagnets. Is that correct?

philipkglass• 6 years ago

Permanent magnets, according to this article:

https://www.fiercebiotech.com/medtech/fda-clears-world-s-fir...

Small permanent magnet NMR spectroscopy units first showed up in chemistry about 10 years ago:

https://www.prweb.com/releases/2010/11/prweb4732684.htm

ISL2• 6 years ago

Ah. Cool. Makes sense, as the field is clean and stable. NIST's Kibble balance does the same. Thanks!

hinkley• 6 years ago

My understanding is that MRI’s use two magnetic fields in opposition. A strong field that is a superconducting magnet of fixed number of Teslas, and an electromagnet that is pulsed to cancel out part of the field. The pulsing creates an echo in the water molecules in the body which is then painstakingly processed into an image. That thunking noise has to do with the pulsing.

I forget what it’s called now but you can build a permanent magnet of upward if .5 or 1T by packing a bunch of keystone-shaped rare earth magnets with differing field alignments into a high tensile strength retaining ring. This causes the fields to be additive, but God help you if you manage to break the damn thing. I watched a video on how to safely put two large rare earth magnets together without shattering them, and YouTube recommended an infomercial by some company at the high end of Tesla ratings for permanent magnets. It was kinda nuts.

jackcosgrove• 6 years ago

From what I saw of this at RSNA, they were only demonstrating head scans. The scanning volume is big enough for a head but not a full body. The magnet is low-power enough that you could walk within a few feet of it during operation without danger.

Cool device which could make MRI scans more accessible, and also paves the way for specialized scanners that only focus on a particular body part. I like medical tech that does a "good enough" job in exchange for being much cheaper than fully featured devices.

toomuchtodo• 6 years ago

This would still be hugely helpful for brain imaging en route to a medical facility, similar to what’s being done with experimental mobile stroke units, so medical practitioners are ready to act upon a patient’s arrival.

mohn2• 6 years ago

Maybe. MRI is not the preferred brain imaging modality in emergency situations, X-ray computed tomography is.

Consider patients who are unconscious (or awake but unreliable) due to head trauma, stroke, etc. You can't do a proper MR safety screening interview to find out if they have ferrous metal or other conductive objects in their head. The magnetic field can potentially torque an old aneurysm clip or piece of shrapnel, and the radio frequency excitation field can cause heating and burns if there are antenna-like conductors present.

MRI is slow and the images are easy to ruin if the subject moves around too much during the long acquisition time, so bouncing around in the back of an ambulance isn't the ideal setting. A 3D volume with whole head coverage and suitably fine spatial resolution can take several minutes to acquire, versus just a few seconds for X-ray CT. The MRI signal to noise ratio is also proportional to field strength, so low field systems like this are at a disadvantage for image quality. On the plus side, low field does mean less risk of moving ferrous material inside the subject.

prostheticvamp5• 6 years ago

MRI is not an emergency technology. Most hospitals will outright refuse to do them for the vast majority of inpatient stays.

This technology will mostly end up in imaging centers, improving throughput.

iCarrot• 6 years ago

Rather than emergency situations, I imagine this would benefit hospitals in poorer, remote areas. For example, an island hospital which have no access to adequate equipment to give adequate diagnosis. Islanders end up having to be airlifted or transported by boats to an inland hospital for anything semi-serious and above.

pvaldes• 6 years ago

This would still be hugely helpful for brain imaging en route to a medical facility

I'm speculating, but probably not. The images would be blurry and unusable if taken in a busy ambulance on road to the hospital. Could do more harm than good.

Having this in a stable home would be awesome on the other hand, but there is too much vibration and everybody trying to grasp handlebars and keep equilibrium when you are in an ambulance on duty.

I could be wrong. I do not master this technology, but if you need absolutely remain motionless in the big machines, I assume than smaller ones would have the same requisite. Ambulances are not stable by default. Everything bounce.

glitchc• 6 years ago

Something that fits a head will also fit a hand, foot, arm, leg, every extremity except torso. The benefits are tremendous.

xbmcuser• 6 years ago

Yeah specially for people that cant sit still in the mri machine. My cousin is claustrophobic he just couldn't stay still enough they had to sedate him in the end.

ska9• 6 years ago

That part is harder than it seems, good quality imaging of many of those locations is hard with a body coil. So the fact you can physically fit a leg in, say, doesn’t give you usable knee imaging. There also may be issues with the shape of the field if it is too tuned to cranial imaging, but the center should be pretty flat.

I’m not saying it couldn’t work with a bunch of extra RF engineering, but it’s not a given. For that matter some locations mist don’t have very good mr imaging regardless of setup.

jcims• 6 years ago

Having a couple of these around might also free up the full sized devices for scans that require a full size device.

m4632• 6 years ago

I was thinking that inexpensive devices might lead to MRIs outside of the 1st world.

quick search shows in 2016 USA has 37 mri/1mm people, mexico has 2 mri/1mm people

voicedYoda• 6 years ago

This is not technical nor attempting to be glib.

I've been to the RSNA, am involved in healthcare software in the USA, and seeing what companies like Phillips, GE, et al, spend on floor space at this conference, it seems difficult to imagine these companies yielding their market position for cheaper machines to reduce costs. MRI equipment is huge business (these companies don't bat an eye spending $1,000,000+ for a conference such as the RSNA because this is where they wine and dine and make every hospital exec feel "special" so when it comes time to buy x MRIs, the sale alone will pay back the conference cost 10 fold. These conferences are expensive. The sales pipe is long (and thus expensive).

There may be companies creating and selling these, but the heavyweights don't like losing a market opportunity in "their" hospitals. I'd be very reticent to think there will ever be lower costs in the ER for offering said device/service.

Please don't get me wrong, I'm excited for limited use machines that can provide the basic information needed at a fraction of the price. I'm very leery of US healthcare institutions making a rational, patient-friendly cost conscious decision.

giarc• 6 years ago

These won't replace existing MRI machines though. These will be an additional purchase by hospitals or purchased for small, rural hospitals that would never buy an MRI machine in the first place.

tootie• 6 years ago

I think the real takeaway is that this kind of device is possible and they've given a blueprint. It will now be possible to start engineering new form factors, have scanners that are mobile, or maybe scan dogs and cats.

collyw• 6 years ago

The magnet is low-power enough that you could walk within a few feet of it during operation without danger.

That was going to be my question. From my current understanding you can't go into the same room as an MRI scanner with any metal in your pockets. The portable nature of this device made me question the safety aspect.

hkiely• 6 years ago

“According to Connecticut-based Hyperfine, their machine will cost $50,000, which is 20-times cheaper than traditional systems, runs on 35-times less power and weights 10 times less than normal 1.5T MRI machines.”

I believe GE came out with MRI machines a while back that were specific for limbs. This really does not seem much different other than it is on wheels and you can possibly position over a torso in a bed if it isn’t metal.

frostburg• 6 years ago

Small models used to scan lab rats also exist (a friend does research on brain damage prevention and I was wondering if they let her use human-rated machines for murine models).

mattkrause2• 6 years ago

The small-bore machines they use for rodents have much stronger fields: 9.4 and 11T field strengths are pretty common. This is a lot easier to achieve in a small bore. For comparison, the “standard” research scanners for humans are usually 3T, with 7T scanners becoming somewhat more available.

That said, many universities do let people use the human scanners for other research. It’s kind of a pain to do with animals, because you’re paying $500 an hour while you scrub the room down afterward and wait for the air to cycle, but it’s the only way to scan larger animals (primates, pigs, dogs, etc).

amluto2• 6 years ago

A hospital billed my insurance $15k for a single MRI series once. This machine could pay for itself very quickly.

hughes• 6 years ago

Especially if you keep billing insurance $15k to use it.

refurb2• 6 years ago

Lots of hospitals love to use MRI’s as a high margin business. I had a contrast MRI where my insurer was billed $20k and paid $16k.

Same MRI at a stand alone clinic is about $2k.

It’s ridiculous.

m3kw9• 6 years ago

NFL gonna buy one of these per team

fyfy18• 6 years ago

How does MRI compare to other techniques (e.g. CAT scans) for general diagnostics? Does it make sense to be used as a more routine diagnostics tool if there are many more machines available?

In the US there are 37 MRI machines per million population, even in other relatively rich countries like France this is much lower at 14 per million population [0]. Is it just the cost of the machines, or are there drawbacks that limit their use as general purpose diagnostics tools?

[0] https://www.statista.com/statistics/282401/density-of-magnet...

dillonmckay• 6 years ago

It would reduce their worker’s compensation insurance costs.

jtlienwis• 6 years ago

Ten years ago I got an MRI when they were searching for kidney stone. I think the hospital charge was over $3000. I had one last year and the charge was less than $500. You can point to MRI as one of the success stories for technology in health care.

semerda• 6 years ago

Which country? Doesn’t sound like a US hospital.

jessriedel2• 6 years ago

You can get a world class MRI in the Bay Area for $550 from SimonMed Imaging.

exhilaration• 6 years ago

There's a ton of small clinics around the U.S. unaffiliated with hospitals that offer MRIs for far less. Just Google it. These places will usually even give you a price ahead of time, you'll never get that from a hospital.

maxerickson2• 6 years ago

Hospitals around here charge ~$2000 for a CT scan. The price isn't coupled to the cost of the machine.

superkuh• 6 years ago

A computed tomography scan is not MRI. It involves ionizing radiation (xrays). Not that an xray scan should cost $2000.

nojvek• 6 years ago

I paid $2000 for a wrist MRI scan in US and $200 for one in Nairobi.

Basically anything in US will be 10X expensive because we have wonderful and very efficient healthcare for doing even the most basic things like CT, XRay, MRI etc. /s

tryptophan• 6 years ago

I wonder what the resolution on these will be like. As I understand it, bigger magnets and more power = higher resolution.

Will this thing have enough to be useful?

dfox• 6 years ago

The reason for huge magnets is to drown out effects of external magnetic fields which would otherwise cause spatial uncertainty. For me this seems like something that can be partially compensated for in software postprocessing given fast enough scan rate.

amluto2• 6 years ago

The magnetic field is to shift the energy levels of the nuclear spin states. The transition energy is proportional to the applied field, and the wavelength of the RF field used for imaging is inversely proportional to the energy. So a stronger field gives a smaller wavelength and thus higher resolution.

ska9• 6 years ago

This is really not correct. External fields are tiny relative to these fields, you have bigger issues with coupling and eddy currents.

It’s not quite as simple as field strength equals resolution, but generally it is easier to achieve high resolution with higher main field strength. See for example mouse scanners at 12T

22c• 6 years ago

It's a ridiculous thought, but I couldn't help but think of the "Thou Shalt Not Covet Thy Neighbor's Goods"[1] skit from "The Ten" where neighbours keep one-upping each other by buying CAT scan machines. It's really crazy to think you could almost have an MRI in your own home these days.

[1] https://en.wikipedia.org/wiki/The_Ten#Plot

carbocation• 6 years ago

This is great. There is a lot of work being done to figure out how much undersampling you can do on a typical MRI and reconstruct a good image. For typical scanners, this gets you faster scan times. It will be interesting to see how much those techniques translate into taking a super low-powered MRI and allow it to yield decent images.

Whether or not such techniques are good for accurately detecting lesions seems to still be a bit of an open question. (It's less relevant to my particular research interests for now, but obviously extremely important for clinical use.)

A lot of the fallout from over-imaging (especially when, like MRI, there is no ionizing radiation so the test itself isn't harmful) is due to physician behavior and standards of care. But those behaviors and standards can change over time.

A bit tangential, but I suspect that at some point, we will think it anachronistic that cardiologists tried to visualize the heart's function by listening to its sounds with their ears.

voldacar• 6 years ago

I heard that ordinary MRI machines can't ever be powered off or they heat up and the expensive liquid helium boils off. How does this particular machine overcome this issue? Seems like it would be a huge problem for a portable MRI

reubens• 6 years ago

If I understand it correctly, the machine uses permanent magnets rather than a giant solenoid.

The magnetic field is way less strong (0.064 Tesla compared to at least 1 in most machines), but the machine doesn't have to generate heat while producing a magnetic field

catblast• 6 years ago

An MRI magnet doesn’t produce heat while producing a magnetic field. That’s not why they are cooled. They are superconductors, the resistance is 0.

anonuser123456• 6 years ago

I think fixed machines are like 1.4 - 3 Tesla field strength. The portable one is like .05 Tesla... So maybe it doesn't even use superconducting magnets.

But you can get high temperature REBCO tape now and get super conductors that can be cooled with liquid nitrogen.

blevs• 6 years ago

MRI machines go up to 7T now.

SubiculumCode3• 6 years ago

.05 Tesla! Seems like there would be poor contrast and SNR. I need images.

lvs• 6 years ago

High field magnets are superconducting alloys that must be kept under liquid helium to remain below their critical temperature. If their temperature rises above the critical temperature, they become Ohmic resistors and can melt -- or at least boil off all their cryogenic helium and nitrogen rapidly enough to be dangerous (so called quenching).

Low field magnets are usually just solenoid coils. There are a number of low-field magnetic resonance devices, including benchtop relaxometers, which use either permanent magnets or electromagnets. This one just uses an electromagnet, I believe, and it looks like it's in a Helmholtz configuration. This is a smaller version of a design used primarily in veterinary contexts, e.g. so you can walk an upright horse into it.

(Edit: Someone below says it's permanent magnets here. Can probably look up their patent or FDA application to be sure.)

refurb2• 6 years ago

I have some experience with NMR from a chemistry perspective. The magnetic field is generated through a super conductive coil. Cool it down with liquid nitrogen, generate the current and you have a superconducting magnetic field as long as you keep it cold.

If it warms up, it’s no longer superconducting and all that current starts generating heat which boils the liquid nitrogen off, which can be quite spectacular. Plenty of videos on YouTube.

So yes, turning the magnet on and off is not trivial at all, but as long as you keep it cold, you’re good.

kragen• 6 years ago

The ones in hospitals normally use liquid helium, not liquid nitrogen, which accounts for the quench being so spectacular and expensive. The nitrogen just keeps the helium from boiling off too fast.

SubiculumCode3• 6 years ago

There is a big red button to quench the magnet in emergencies, but it can cost a lot of money to get the MRI going again.

cma3• 6 years ago

There are superconductors that can use cheap liquid nitrogen now.

remarkEon• 6 years ago

I don't work in medical devices per se, but I do work in hardware.

I see lots of immediate uses for this. Pro-sports will obviously want it, the military will too, field hospitals in e.g. Africa. Lots of possibilities here.

Can anyone tell me where this device will be manufactured?

Amarok7• 6 years ago

For a change, I can contribute something to HN without being out of my depth:)

Background: I'm a doctor with 3 years experience in acute medicine. AMA

Clearing some MRI misconceptions: 1. It's indicated ASAP in specific emergencies and will change how we manage them. For acute ischaemic stroke, it detects patients within the recomended time window for thrombolysis. Simply, it shows the cellular swelling in the brain, gives an estimate of the onset and we decide the risk/benefits of dissolving the clot. Second use, for cauda equina syndrome. Again we're looking for acute CNS tissue damage, this time from spinal chord compression, and the change in management is emergency neurosurgery (good luck getting them out of bed without an MRI) For herpes encephalitis, MRI is debatable because you can start empiric treatment. But I've seen it done.

Another misconception for the first use scenario in stroke. The MRI sequences we're interested in only take 1-3min and CT doesn't help us. But in my experience the whole scan takes 2h to organize, so point of care MRI is a game changer. Every minute counts when you're saving brain tissue. And Lower definition with artifacts are acceptable because you're looking for gross changes in a critically unwell patient.

Bonus: A report from when I managed my first suspected stroke as a junior doctor.

"49yo lady day 1 post op for total knee replacement (elective admission). Commorbidities of hypertension, obesity and osteoarthritis. She was just started on apixaban and gabapentin as per protocol, when I was asked to see her for new onset upper limb bilateral tremor.

On examining her I found the symptoms had started 1h ago. She was presenting bilateral upper limb ataxia as well, reflexes were reduced on the left and there was numbness corresponding to C4 dermatome. At this point I was worried about acute stroke whithin the 4h window for thrombolysis. I discussed the case with the acute stroke consultant and examined the patient with him. We requested an MRI brain to assess for acute posterior circulation stroke, because he thought time of onset was unclear (as per WAKE-UP protocol). I acompanied the patient to neuroradiology services. The MRI sequences we were most interested was DWI and FLAIR which only took a few minutes. We quickly scanned through the images noting there were was no DWI-FlAir mismatched high intensity signal areas within the brain parenchyma. This allowed us to rule out acute ischaemic stroke.

6h later the symptoms subsided and I was satisfied they were due to an adverse reaction to gabapentin."

lijf2• 6 years ago

Being a neuroradiologist (at Karolinska in Stockholm, Sweden) I really love the idea of this and almost can’t wait to start doing comparative studies to find how sensitive it really is. As I see it there are a couple of areas where it could be of tremendous use - first of course the (neuro) intensive care unit, where patients sometimes are to unstable to transport to the MRI, and where every transport is a potential risk for the patient, and where it can be very useful to find out whether they have ischemic lesions in the brainstem (which can be difficult to rule in/out on CT) or extensive diffuse axonal injuries, etc.

Another area would be pediatric imaging, where it could be useful as a first imaging, ruling out larger lesions, possibly lessening the need for CT and decreasing radiation exposure, especially in the group approximately 1-4 years, who often need sedation to lie sufficiently still inside the MRI. Although at my institution the physicists have developed a ‘fast MRI’ (70 seconds), that gives reasonable resolution and contrast (T1,T2,T2*,DWI), and which we will try to implement in the group of patients who come to ‘try’ the machine (before deciding whether they need sedation or not).

Also, the low field strength, 0.064T vs 1.5T or 3T, would most probably allow us to image patients with implants which are unsafe at normal clinical field strengths of 1.5 or 3T (would have to be verified though).

For people interested in low field imaging the group at Athinoula A Martinos Center for Biomedical Imaging at Harvard has a homepage at https://www.nmr.mgh.harvard.edu/lab/lfi

hliyan• 6 years ago

Thank you (and the grandparent poster). We (or at least I) love seeing more HN participation from insightful professionals from outside the tech industry!

radicalbyte2• 6 years ago

The combination of the cost and accessibility look like a game changer for me, a lay-ish person.

With such a device, do you need a Radiologist or other rare super specialist to actually read the images? Or can they be used by generalists?

Will this turn brain MRIs into a tool comparable to the X-Ray scanner my dentist uses or the Ultrasound used by the midwives a dozen times during pregnancy?

If so it looks like a game changer - something which will become a fixture in A&E departments everywhere.

luddaite• 6 years ago

Will ER rooms need to be re-designed to accommodate bedside MRI? The ER at the hospital I work at already has special rooms for Gyn and Ophtho complaints so it wouldn't be that far fetched for there to be a room designed for Stroke code patients.

mdorazio2• 6 years ago

It says the clearance includes head scanning, but could this also be used for things like orthopedics? Current MRIs are prohibitively expensive and bulky for all kinds of things outside head trauma that could benefit from tissue imaging.

Amarok7• 6 years ago

Oh orthopods, they're a riot in the Uk. They won't have much use for a portable MRI. In trauma all they see is the bony bits where CT and XR are king, anything else is someone else's problem. A true ortho emergency is rare and patients can wait for surgery if neurovascular intact. They do have time guidelines to operate neck of femur fractures (still won't operate out of hours though). But an XR is often enough to proceed . A few caveats I can think of... For fulminant infection like necrotizing fasciitis: straight to OR, open and have a look at the tissues. Joint infections: stick a needle in and await results. Bone infections benefit from MRI but there's no change in management while stabilizing on antibiotics, plenty of time to arrange a scan.

Then we move on to elective surgery (planned). MRI with the best available resolution will increase diagnostic specificity and avoid unnecessary operations to labrum's, meniscus, etc. They don't need to be done in hospital and you can shop around.

At this point we're looking for problems to fit this solution, poor business model. Not surprisingly, limb only MRI machines haven't been successful.

treeman79• 6 years ago

gabapentin gave me full on Parkinson’s symptoms. They would take several days to hit, and several days to resolve from a single pill. So it took a couple months to figure out what was going on.

Doctors had no clue what was going on.

Some of these meds are beyond scary.

Kids still wake up from nightmares of having family and teachers preparing them from what seemed a likely funeral.

See a different doctor and explain symptoms. “Oh yes, it some times does that.”

Getting correct diagnosis and meds is such a tricky topic.

prostheticvamp5• 6 years ago

For herpes encephalitis, MRI is debatable because

I’m curious kind of institution you’re at? Everywhere I’ve been (NE) it’s fallen down academic lines: adverse impact of unneeded antiviral tx vs. mortality benefit in hsv encephalitis is incredibly one-sided, and time sensitive. Academic tertiary care institutions basically considered it borderline malpractice not to just initiate antivirals and d/c later. Non-academic secondary care institutions agreed in theory, but basically only started antivirals if everything else was off the table and/or imaging was characteristic (aka, either too damn late or later than it should be), but cases were rare enough it didn’t mean much in practice.

Amarok7• 6 years ago

NE as in North East? I'm in the same region at a small academic center.

Saw 3 suspected cases recently, all started acyclovir within 1h in addition to the antibiotics, while awaiting lumbar puncture.

Gatsky• 6 years ago

Really nice piece of work.

The key patent makes for interesting reading [1]. They use neodymium permanent magnetic rings. I wonder if building a crude version of Hyperfine’s machine is within the realms of a DIY project.

[1] http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=H...

ihnorton• 6 years ago

The MGH Martinos Center has a very nice open source MRI page with hardware and software instructions to build a functional, low-resolution tabletop MRI (I think this is primarily targeting instructional use at a university level, so requires a fair amountof background):

- https://www.opensourceimaging.org/project/instructional-tabl... - https://tabletop.martinos.org/index.php/Main_Page

petespeed• 6 years ago

"To reserve your Hyperfine system(s), the following conditions apply:

    You must be an accredited US health care provider.
    System usage is approved for patients 2 years and older.
    Your institution must be able to supply a wired ethernet connection to the device once every 14 days."

amelius• 6 years ago

Curious about that last condition. What is it used for? And what bandwidth does it need?

ObsoleteNerd• 6 years ago

Licensing and/or updates?

_Microft• 6 years ago

I'm only familiar with other, not medical, devices and my guess would be that this is about firmware updates.

chmod775• 6 years ago

Portable is a relative term.

Some hospitals in Germany actually have vehicles containing MRI units which they dispatch when a stroke is suspected.

docdocgoose• 6 years ago

Reduced power and cost requirements are critical for this technology to be viable for low middle income country (LMIC) settings, particularly in rural areas. In many sub-Saharan countries, there are A handful in the country and use is complicated by unstable grids. High impact tech if use cases for these settings are sharpened.

jawns• 6 years ago

I was talking recently with a Haitian doctor, who said that in his entire country (of 11 million people), there is just one MRI machine.

This new device seems like it will break down so many barriers, both in terms of cost and practicality, in Haiti and other developing countries.

I hope it makes its way there!

tinus_hn• 6 years ago

I wonder how long it’ll take for these to appear at the airport checkpoints.

aj7• 6 years ago

Remarkable they have enough sensitivity at 0.064T. To me, that’s the underlying scientific breakthrough. It implies that that there are other, intermediate regimes that would not require bulky, expensive superconducting magnet.

mentos• 6 years ago

I wonder if it would be possible to up sample the images using AI/ML?

FDA clears ‘world’s first’ portable, low-cost MRI

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