FDA Clears 'World's First' Portable, Low-Cost MRI Following Positive Clinical Research (healthimaging.com) 26
Magnetic resonance imaging is no longer confined to radiology departments. The U.S. Food and Drug Administration announced this month that it has provided clearance to the "world's first" bedside MRI system, according to an announcement. From a report: Hyperfine said it will begin shipping its portable, low-field modalities this summer. It's 510(k) clearance falls on the same day that Yale researchers reported the device can accurately and safely image patient's brains for stroke. Those preliminary results are set to be presented next week at the American Stroke Association's International conference in Los Angeles, the group announced. "We've flipped the concept from having to get patients to the MRI to bringing the MRI to the patients," said Kevin Sheth, MD, senior author and a chief physician at Yale School of Medicine. "This early work suggests our approach is safe and viable in a complex clinical care environment."
The study included 85 stroke patients who underwent bedside MRI within seven days of experiencing symptoms. A majority of individuals completed the exam, which took an average of 30 minutes. Six experienced claustrophobia and a few couldn't fit into the machine, but there were no adverse events. 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.
The study included 85 stroke patients who underwent bedside MRI within seven days of experiencing symptoms. A majority of individuals completed the exam, which took an average of 30 minutes. Six experienced claustrophobia and a few couldn't fit into the machine, but there were no adverse events. 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 wonder if they will be charging the same amount (Score:2)
as a full-scale MRI?
At this price point, even (some) doctors offices can buy one.
And do you need a special hospital room, with no metallic items in it?
Re: (Score:3)
It's a low-field MRI. You don't need to clear metal out of the area.
It's also small, and can basically only be used for imaging the head, but this could be really great for stroke treatment.
Re: (Score:1)
Re: (Score:3)
Re: (Score:2)
Have you ever known doctors or pharmaceutical companies to lower the cost of anything?
Sure, the costs for the same procedure or prescription will come down but then they just move to a more expensive procedure or prescription that used to be only available to billionaires and government officials years before.
I'll give an example. I remember as a kid I was prescribed amoxicillin for an infected tooth, something that then might have cost a few bucks to produce. Many years later as an adult I was prescribed antibiotics once where I found out was a far more expensive drug and unlikely to be a
Re:I wonder if they will be charging the same amou (Score:5, Informative)
I was wondering when something like this was going to come out. There had already been the development of portable CT scanners for ICUs about 10 years ago. Development of portable head MRI units was an obvious next step. Additionally, unlike for CT, scaling down a CT scanner doesn't help all that much in terms of cost. Whereas for MRI, the cost savings are vast.
There are major disadvantages with this machine, however. You wouldn't want to use it if you had access to a more conventional MRI scanner. It is very low field due to the use of permanent magnets - this cuts your signal-to-noise ratio by an order of magnitude, and takes away a huge amount of flexibility in terms of resolution/speed trade off. You could do a minimal head exam in 30-40 minutes, whereas a high quality superconducting system could do a full neuro protocol at double the resolution with far higher diagnostic performance in the same, or do the minimal protocol at the better resolution and better SNR in 10 minutes. There is also the issue of size - the system is extremely small, and far more claustrophobia inducing than a conventional scanner (for head scans). The low field strength also translates into terrible performance for detection of small blood clots (like epidural or subdural hematomas) - the visibility of the blood depends on it's magnetic properties, and the interaction with the scanner's magnetic field. Stronger magnetic field drastically increases this effect, over and above the drastically higher SNR.
However, for the intended use case, which is neuro ICU where patients are too unwell to be transported to the MRI department, this is an incredible development. You can diagnose stroke with near 100% accuracy without leaving the ward. You can also diagnose other causes of sudden deteriotation, like hydrocephalus, large epidural/subdural hematomas. By avoiding the need for a complex transfer (potentially with extensive support equipment, such as ventilators, monitoring equipment, etc) you can shorten the time to diagnosis, and therefore treat the cause of the deterioration faster.
This unit does not compete as a replacement for a general purpose superconducting system for non-urgent cases, but may have a role in situations where a superconducting MRI system is unaffordable, such as developing countries, where the cost of even a basic MRI scan can exceed a month's wages. Most importantly, due to it's small size, it will not be able to fit body parts larger than the head - so would be limited to extremities like wrists, hands, feet and knees, and possibly the neck.
In some sites, portable CT is being used for a similar purpose - but even the best CT is poor in terms of anatomical detail compared to even low field MRI. There are also significant radiation protection concerns when portable CT units are used, for both staff and other patients - as ICU rooms lack the lead-lined walls of a proper CT suite. This MRI unit avoids the radiation concerns.
In MRI, the major costs are the magnet - typically a superconducting system of 1.5 T or 3T. These are large complex and very expensive devices, requiring substantial energy and substantial support plant - and the gradient set (a set of 3 orthogonal electromagnets which dynamically distort the main magnetic field in a precisely controllable way). The costs of superconducting magnets scale roughly proportionally to the radius to the 4th power, and the cost of the gradient equipment scales roughly proportionally to the radius to the 5th power. The move from 60 cm diameter MRI systems (which are limiting due to claustophobia and in the case of obesity) to 70 cm systems (which are now standard) has come with a rise in cost.
The change in diameter also needs a significant increase in support plant. One manufacturer is offering an refurbishment service for their old scanners which replaces the gradient system with a much thinner system, increasing the bor
Re: (Score:2)
Someone mod this post up 5 to the fifth power Informative!!!
Re: (Score:2)
Re: (Score:3)
The move from 60 cm diameter MRI systems (which are limiting due to claustophobia and in the case of obesity) to 70 cm systems (which are now standard) has come with a rise in cost.
After reading this I had to measure across my shoulders and I'm not sure I'd fit through a 60 cm hole. I had an MRI scan of my feet before, and I'll have another soon, and last time they apparently had a minor issue of how to hold my big feet in place. I'm a fairly big guy at 6 feet 5 inches tall and about 225 pounds but I'm thinking of those bigger than me, and not because of obesity. I'm thinking of how professional athletes get their MRI scans when they need them, guys that are over 7 feet tall and ov
Re: (Score:2)
They don't need MRI scanners with a 60 cm hole to scan even my big feet, 35 cm would be enough.
There are already small MRI machines for extremities for ortho and sports medicine practices. They are about the size of a small refrigerator. Not portable like this one of course, and they operate a much higher field strength (1.5T and up).
Re: (Score:2)
Only $50k? Wow. (Score:1)
At that price, I'd almost tempted to own one personally. If you add up the radiology bills of an average person over the course a lifetime, it's probably cheaper for everybody to buy one and keep it in their cars just in case.... :-D
Re: (Score:2)
Re: (Score:2)
Except this device is pretty much outdated already. The only thing this does is make it portable enough but it's nowhere near the resolution that it requires for full diagnostics.
Basically what they do with this one is triage if you had an event and with sufficient time, you could do some basic analysis. If you need a more detailed picture for eg surgery, you'll still want your full-size MRI, but you can at least eliminate some expensive time on a magnet if it would prove unnecessary.
Re:Only $50k? Wow. (Score:4, Interesting)
Outdated?
The Hyperfine folks have done something astonishing, creating images that are nearly as good as slap-dash 1.5T images that you would take in a triage environment, except with a 0.065T magnet. That's two, count them, two orders of magnitude lower field. They state the use-case of their newly approved device is specifically for triage and that it does not replace a normal high-resolution, high-field scan.
But, what they don't talk about is the following: if you could take their secret sauce (which is likely better space-filling curves, better overlap/spectrum-wrap reduction, and better noise reduction, off the top of my head) and apply it to normal MRI machines, you'd be able to drop imaging time by at least one order of magnitude to get equivalent images, or get 10x better images with the same time.
The first scenario makes the bean counters excited, but the second scenario is the one that makes my hair stand on end. MRI is a great tool, but it has crap for resolution and contrast in many brain structures -- while 1 cm slices are fine for diagnostics when you're concerned about a tumor, hematoma, edema, aneurysm, or similar insult, for research, we need 0.1 mm slices.
I can't wait until one of the big players like Siemens or GE buys them and incorporates their IP into the big scanners.
Re: (Score:2)
Hey Moe, how come you never got cable for the bar? (Score:4, Funny)
"Well, it was either cable or the world's most portable MRI. I made my choice, and I stand by it.â
*MRI machine standing in corner, covered in dust and spiderwebs."
20 times cheaper? (Score:2)
Re: (Score:2)
Well as a non-math major regular schmoe:
This gizmo costs $50,000 and it's 20 times cheaper than a normal MRI? The normal machines must cost a million bucks!
*google prices of MRI machines* ... yup, 1 to 3 million depending on the type, it looks like.
Re: (Score:2)
It's supposed to say that it's 1/20th of the cost. But it's the incorrect usage of "x times less than y", which even has a dedicated domain (https://timesless.com/).
Thinking in percents, 50% less is 0.5 times less and 100% is 1x less. Thus 20 times less would be 2000% less. So if an MRI cost one million dollars, the new device would cost -19 million dollars... This is one of these so common mistakes - I can still understand well what it means, but it bugs the heck out of me.
Does it need helium cooling? (Score:1)
Putting a conventional MRI by at your bedside wouldn't help the growing shortage of helium, but if this thing has weaker magnets, perhaps they don't need it.
"tiimes less" is moronic (Score:2)
I should probably make peace with this stupid direction that written English has gone, but man, I hate it when writers use the combination of a number greater than one with multiplication ("times") along with the word "less" to indicate something that is smaller.
"The new system is 20-times cheaper" should be "The new system is one twentieth the price" or "The old system is 20-times more expensive".
"The new system runs on 35-times less power" should be "The new system uses one thirty-fifth of the power" or "
Re: (Score:2)
And "tiimes" is even more moronic. I should just go back to bed and try to start over tomorrow.
This is for diagnosis, not treatment (Score:3)
Cheap MRIs with algorithmic interpretation (Score:2)