- No public price. Per the FY2025 10-K summary, systems are owned, with an annual software, service and support agreement after a one-year warranty on 36- or 60-month terms. Dollar amounts were not found.
- Not disclosed
- Not disclosed
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- US
Radiology
Hyperfine Swoop
by Hyperfine · US
Portable 0.064T brain MRI (Swoop) with Optive AI image reconstruction. Also BrainInsight AI brain morphometry.
On this page
35/100Competitive
- Regulatory & Compliance18/28
FDA cleared (17 K-numbers on record)
- Clinical Integration0/26
No EHR integrations listed
- Evidence Strength12.7/26
4 peer-reviewed papers
- Vendor & Market6/18
Early-stage company
- Sentiment & Transparency2.5/14
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance18/18
FDA cleared (17 K-numbers on record)
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- EHR integrations (count)0/14
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/8
None of the top-3 EHRs covered
- Bidirectional write-back0/4
No bidirectional write-back documented
- Peer-reviewed papers13/18
4 peer-reviewed papers
- RCT / meta-analysis / systematic review0/8
No RCT, meta-analysis, or systematic review
- Funding & adoption signal6/12
Early-stage company
- Years in market0/6
Founded year not recorded
- Clinician sentiment (Reddit)0/9
No clinician sentiment data available
- Pricing transparency3/5
Pricing on request, no public amounts
Portable 0.064T brain MRI (Swoop) with Optive AI image reconstruction. Also BrainInsight AI brain morphometry.
No public price. Per the FY2025 10-K summary, systems are owned, with an annual software, service and support agreement after a one-year warranty on 36- or 60-month terms. Dollar amounts were not found.
Bottom line
The Swoop is a portable brain MRI scanner from Hyperfine, Inc. that runs at 0.064 tesla, a small fraction of the field strength of a conventional hospital magnet. It needs no shielded room, which is why the literature describes bedside use in the ICU and in resource-limited settings. Deep-learning reconstruction, sold as Optive AI, reduces noise and blur in the images. The Swoop is not a replacement for a fixed 1.5T or 3T scanner. It answers specific questions when conventional MRI is undesirable or impossible, and a department that needs contrast-enhanced studies or fine anatomical detail still needs the conventional scanner.
What is the Swoop and who makes it?
The vendor describes it as "an AI-powered, portable brain MRI that uses a magnet with a fraction of the field strength used in conventional MRI," and claims diagnostic-quality imaging. Hyperfine, Inc. (Nasdaq: HYPR) is based in Guilford, Connecticut. Jonathan Rothberg founded it in the 4Catalyzer incubator, served as CEO from 2014 to 2021 and remains on the board, per Wikipedia.
Hyperfine is growing but still loses money. Second quarter 2026 revenue was $3.9 million, up 44.8 percent, with a net loss of $9.3 million per a Yahoo Finance summary. Preliminary third quarter revenue is about $6.0 million, up 55 percent, with about $37.9 million in cash. Full-year 2026 revenue guidance is $20 million to $22 million, and full third quarter results are due November 9, 2026.
What can it image, and what are the limits?
It produces structural brain sequences: T1, T2, T2-FLAIR and diffusion-weighted imaging. Optive AI, which the vendor describes as AI-driven image reconstruction for ultra-low-field MRI using deep learning to reduce noise and blur, rolled out to the installed base in July 2025 and received CE and UKCA marks in August 2025. BrainInsight, a separate AI brain morphometry software, has three FDA records of its own, listed below.
Papers on low-field use, including a Malawi experience paper in BJR Open, describe lower signal-to-noise ratio and resolution than 1.5T and 3T, longer scan times, no contrast-enhanced T1 imaging and constraints on coils. A Scientific Reports paper rates image quality below that of higher-field systems. One review calls for validation of diagnostic performance and cost-utility. The same literature credits the Swoop with portability, bedside use in the ICU and use where a magnet-shielded room cannot be built.
What does the FDA record show?
FDA's 510(k) database lists 17 records for Hyperfine, and they trace the system from the first one, K192002 for the Lucy point-of-care MRI, decided February 6, 2020. Swoop clearances follow through K201722 (August 11, 2020), K212456 (November 17, 2021), K232760 (October 6, 2023), K240944 (July 16, 2024), K250236 (the V2 system, May 30, 2025) and K253489 (December 12, 2025). The most recent is K262622, decided August 19, 2026. BrainInsight carries K202414 (January 7, 2021), K220815 (July 19, 2022) and K223268 (December 16, 2022). Which clearance covers Optive AI is not stated.
What does the evidence say?
Four papers from 2024 and 2025 cover portable ultra-low-field MRI. They address tips and challenges for low-field MRI in neuroimaging (Emergency Radiology, 2025), the Malawi case review (BJR Open, 2025), super resolution from sparse sampling at portable ultra-low field (Frontiers in Neurology, 2024) and brain-age estimation at ultra-low field. The last is a medRxiv preprint and is not peer reviewed. The titles do not say whether each used the Swoop.
What does it cost?
Hyperfine calls the system "cost-effective, easy to implement, and eligible for reimbursement" and gives no dollar figure. According to a summary of the FY2025 10-K, the model is ownership plus an annual software, service and support agreement after a one-year warranty, on 36 or 60 month terms. An older Scientific Reports paper estimated about $50,000 per system. The 10-K sets conventional MRI at about $1.2 million on average. Current dollar amounts for the system and the service fee are not public, and the reimbursement status of Swoop scans is not documented.
How does it compare?
Siemens Magnetom Free.Max is a low-field alternative at 0.55T against the Swoop's 0.064T.
The verdict
The Swoop earns its place in an ICU or a hospital in a low-resource region, where a patient cannot reach a fixed magnet or the site cannot build a shielded room, and Hyperfine's 17 FDA records show a deep regulatory history. It is a complement to conventional MRI, and the published papers put its image quality below 1.5T and 3T. A radiology department with ready access to a fixed scanner gains little from it, and the manufacturer is not yet profitable.
Editorial review last generated October 15, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | — | — | No public price. Per the FY2025 10-K summary, systems are owned, with an annual software, service and support agreement after a one-year warranty on 36- or 60-month terms. Dollar amounts were not found. |
Source: vendor pricing page. Last checked October 15, 2026.
What deploys cleanly
Carries FDA 510(k) (multiple) per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
What the literature says
4 peer-reviewed studies indexed on PubMed evaluate Hyperfine Swoop in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.
- Super resolution using sparse sampling at portable ultra-low field MR.
- Donnay C, Okar SV, Tsagkas C, et al.· Front Neurol· 2024
- Ultra-low field (ULF) magnetic resonance imaging (MRI) holds the potential to make MRI more accessible, given its cost-effectiveness, reduced power requirements, and portability. However, signal-to-noise ratio (SNR) drops with field strength, necessitating imaging with lower resolution and longer scan times. This study introduces a novel Fourier-based Super Resolution (FouSR) approach, designed to enhance the resolution of ULF MRI images with minimal increase in total scan time. FouSR combines spatial frequencies from two orthogonal ULF images of anisotropic resolution to create an isotropic…
- Tips and challenges for clinical use and interpretation of low field portable MRI in neuroimaging.
- Chen YA, Mathur S, Lin A, et al.· Emerg Radiol· 2025
- Low field portable MRI (LF pMRI) is a new imaging tool that holds promise in offering a safe, cost-effective, point-of-care imaging solution in neuroimaging. There are however unique interpretive challenges and operational factors and limitations in its implementation in clinical practice. This paper aims to provide a comprehensive guide on the tips and tricks of interpreting LF pMRI, specifically the Hyperfine Swoop® MRI system, which operates at 0.064 T and is currently the only FDA and Health Canada approved LF pMRI system. This paper explores the operational aspects and interpre…
- Case-based review of low-field MRI in resource-constrained settings: a clinical perspective from Malawi.
- Chetcuti K, Chilungulo C· BJR Open· 2025
- Low-field MRI (LF-MRI) is in the spotlight as multidisciplinary experts consider it to be one solution to expanding MRI access worldwide. The clinical scenarios and case-mix in which LF-MRI could play an especially important role in the patient diagnostic algorithm are different in High and Low- and Middle-Income Countries (LMIC). The aim of this article is to suggest a robust structure within which to envision clinical use and advancement of LF-MRI technology in LMICs. This article presents three discrete clinical scenarios-a tertiary care facility with an LF-MRI only, a tertiary care facili…
- Brain-age in ultra-low-field MRI: how well does it work?
- Biondo F, Bennallick C, Martin SA, et al.· medRxiv· 2025
- Brain-age is an estimate of the brain's biological age derived from neuroimaging data, and has been proposed as a biomarker of brain health and disease risk. While brain-age estimation commonly uses high-field (HF) magnetic resonance imaging (MRI) (1.5 T) this is costly and inaccessible, limiting its applicability. Emerging ultra-low-field (ULF) MRI (0.1 T) technology is a cheaper and more accessible alternative, but its lower resolution raises questions about whether biomarkers like brain-age can be estimated reliably. We assessed different brain-age pipelines in 23 adults scanned on one HF…
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