
FDA clears ‘world’s first’ portable, low-cost MRI - apsec112
https://www.healthimaging.com/topics/healthcare-economics/fda-clear-worlds-first-portable-mri
======
Amarok
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."

~~~
lijf
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](https://www.nmr.mgh.harvard.edu/lab/lfi)

~~~
radicalbyte
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.

~~~
lijf
You are of course right about the cost and accessibility, low field not
necessitating specific rooms or ‘no go’ zones, and presumably easy operation
(controlled via iPad app) being very interesting with regards to increased
availability of MRI scans(in Sweden the rate limiting step at the moment is
usually the availability of trained MRI technicians). In my initial comment I
mostly thought about some clinical situations in my current practice where it
would be useful. Sorry if the following becomes a bit rambling.

Reasonably there are a plethora of indications and given that these machines
will be installed at the point of care (A&E, ICU, etc) and supposedly are safe
to use on basically all patients, one can imagine that it will be used very
frequently. Though in this case the scan-time (30 min + change) could become a
limiting factor (but, given it’s price, I guess you could just buy more
machines). The image quality is of course not the same as with a modern
clinical system but it is most certainly good enough for a preliminary test,
and may very well decrease the number of patients sent for a ‘normal’
diagnostic scan (though the opposite may also be true, if you see something
unexpected in the images, or if there are artefacts which are difficult to
interpret). As with the ‘fast MRI’ I referenced to earlier, my current idea
would be that it can be used as an initial screening, but, as always, if the
test is normal, but the clinical suspicion persists one would have to continue
with other tests.

Regarding whether the image should be read by a specialist or not, I am of
course biased towards the specialist :) As I see it the main advantage of
having the clinician interpreting the image is that they have ‘direct access’
to the patient, and can ask them specific questions based on the findings of
the test. Though, time-utility wise it’s faster for a specialist to read a
normal test. During med school I did a rotation at a primary care facility in
the north of Sweden, in a municipality with 6000 inhabitants, located almost 2
hrs away from the closest hospital, the GP:s there read chest x-rays
themselves at that time. Now the images are transferred digitally to the main
hospital of the region and read by a radiologist. One can of course wonder
whether it’s cost effective to train a large number of radiologists to read
all the new studies which will be produced. My hope here is that computer
aided diagnostic tools will increase the productivity of radiology
specialists.

My experience from working together with neurosurgeons and neurologists who
are very good at reading images in general, is that they anyway prefer to
consult us for the interpretation, (they would rather operate than become
specialist radiologists). In my opinion the professionals at risk of being
side-stepped are the general radiologists, and I think this is already
happening as telemedicine makes it possible for smaller hospitals to pay for
specialist readings on a per study basis.

edit: regarding time utility, one would of course have to include the time it
takes for the referring physician to write a request, and for the radiologist
to write a report. And another advantage of having the clinicians read the
image is that they have more information about the patient than they put in
the request. So it’s also very possible that radiologists will not be
consulted (depending on medicolegal circumstances and reimbursement systems
etc.)

~~~
Amarok
My experience as well is that there's a relationship of trust between
radiologist and surgeon that a trained algorithm cannot replace. Same reason
why AI isn't a threat to sales people for high priced items.

I'm actually doing what we call a taster in neuroradiology and it's been
fascinating. Strongly considering applying for residency next year!

I did my elective at the PET center in Turku, great team. They even let me
play with the rat MRI for Alzheimer's. They had some cool projects under Marco
Bucci at the time, I believe he just started at Karolinska.

------
jackcosgrove
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
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.

~~~
mohn
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.

~~~
01100011
> You can't do a proper MR safety screening interview

Are we really not capable of detecting such dangers externally without patient
input? It seems like detecting even small pieces of metal would be relatively
trivial.

~~~
askvictor
Presumably with an X-ray/CT scan.

~~~
numpad0
Can’t you apply a minuscule power and watch out for overcurrent?

~~~
ska
No, the main field is effectively permanent.

~~~
numpad0
I mean, some sort of non-super-conducting MRI analogue device that the patient
will have to go through.

~~~
ska
You could find big things that way, but maybe not small things that were deep.
I suspect it is hard to make something powerful enough to detect everything
that might be an issue in say a 7T field, yet still safe.

------
hkiely
“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.

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

~~~
refurb
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.

~~~
copperx
A 1.5T torso MRI costs me $260 US dollars in Mexico without insurance and
without prescription, radiologist interpretation included. Salaries are higher
in the US and I assume the bleeding edge tech is multiple millions of dollars.
But even with those considerations, I don't think $20K is justified.

Sure, they don't have fast 3T machines, but still are useful for DIY cancer
screening for the paranoid like me (for those that aren't familiar with
imaging tech, MRIs don't use radiation).

~~~
omgtehlion
In Russia torso MRI costs around $200-$300 too. Smaller exams on outdated
machines could be found for as cheap as $80.

It is solely US thing that medical procedures have astronomical cost.

~~~
jaclaz
In Italy, my mother did a few months ago a contrast MRI (spine), directly paid
in a private laboratory (outside the national service) for around 300 Euro.

Which makes sense if the machine cost is around 1,000,000, appointments were
every half an hour, so, let's say they make 15 scans per day at 300 each, it
makes 4500 Euro/day by 220 days/year that is around one million Euro/year.

You take out of it - say:

250,000 Euro for the machine (for 5 years)

250,000 Euro for personnel

250,000 Euro for maintenance, power, other costs

50,000 Euro for _something else I don 't know_

And you are still ahead for 200,000 Euro/year, i.e. roughly 20% of your
investment.

------
Gatsky
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...](http://patft.uspto.gov/netacgi/nph-
Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-
bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=10222434.PN.&OS=PN/10222434&RS=PN/10222434)

~~~
ihnorton
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://www.opensourceimaging.org/project/instructional-tabletop-mri-
scanner/) \-
[https://tabletop.martinos.org/index.php/Main_Page](https://tabletop.martinos.org/index.php/Main_Page)

------
carbocation
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.

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

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

------
voldacar
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

~~~
anonuser123456
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
MRI machines go up to 7T now.

~~~
m463
Wow, makes me wonder about adverse effects. Could you magnetize the hemoglobin
in your blood?

------
jawns
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!

------
22c
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](https://en.wikipedia.org/wiki/The_Ten#Plot)

------
docdocgoose
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.

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

~~~
philipkglass
Permanent magnets, according to this article:

[https://www.fiercebiotech.com/medtech/fda-clears-world-s-
fir...](https://www.fiercebiotech.com/medtech/fda-clears-world-s-first-
portable-bedside-mri)

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

[https://www.prweb.com/releases/2010/11/prweb4732684.htm](https://www.prweb.com/releases/2010/11/prweb4732684.htm)

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

------
chmod775
Portable is a relative term.

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

------
m3kw9
NFL gonna buy one of these per team

~~~
fyfy18
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...](https://www.statista.com/statistics/282401/density-of-magnetic-
resonance-imaging-units-by-country/)

------
remarkEon
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?

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

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

~~~
copperx
Is that cash price? Does that include the radiologist interpretation? And can
you get one without a prescription?

~~~
jessriedel
Cash price. Based on how the thing was billed, I am 90% sure it included
interpretation, but at this point I can't remember for sure. I don't know
whether the prescription is mandatory, but I'm sure you can email/call them.

------
aj7
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
I wonder if it would be possible to up sample the images using AI/ML?

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

------
tryptophan
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
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.

~~~
amluto
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.

~~~
exikyut
Oooh, in the same way that the higher 5G frequencies don't travel as far!

