Swoop® Portable MR Imaging® System

by Hyperfine  · Based in United States → — Bringing MRI to the patient, wherever they are.
Emergency Medicine General Surgery Internal Medicine

Enterprise
Documentation ProvidedRegulatory Status Disclosed

Overview

The Hyperfine Swoop® Portable MR Imaging® System represents a significant advancement in medical imaging, offering the world’s first and only FDA-cleared portable MRI solution. Designed to overcome the traditional barriers of fixed MRI systems, Swoop enables high-quality brain imaging directly at the point of care. This innovative system is particularly valuable in settings such as intensive care units (ICUs), emergency departments (EDs), stroke units, and pediatric wards, where patient transport to a conventional MRI suite can be challenging, risky, or time-consuming.

Physicians can leverage the Swoop system to obtain critical neurological insights rapidly, facilitating quicker diagnoses and more timely treatment decisions for conditions like stroke, hydrocephalus, traumatic brain injury, and other neurological disorders. Its compact size, low power requirements, and standard wall outlet compatibility mean it can be deployed in virtually any clinical environment, expanding access to MRI technology beyond traditional radiology departments. This portability not only enhances patient safety by reducing the need for transfers but also improves workflow efficiency for clinical teams.

The Swoop system features an intuitive iPad-based interface, making it user-friendly for a broad range of healthcare professionals. It utilizes AI-powered image reconstruction to deliver clear, diagnostic-quality images with rapid scan times. Furthermore, its DICOM compatibility ensures seamless integration into existing PACS (Picture Archiving and Communication Systems) and allows for remote access, supporting tele-radiology initiatives and collaborative care models. This tool empowers physicians to bring advanced imaging capabilities directly to the patient, improving diagnostic pathways and patient outcomes.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Portability and compact design
  • Low power consumption (standard wall outlet)
  • Intuitive iPad-based interface
  • AI-powered image reconstruction
  • Rapid scan times
  • Point-of-care imaging capabilities
  • DICOM compatibility for PACS integration
  • Remote access for tele-radiology
  • Minimal infrastructure requirements
  • Patient-centric design

Use Cases

  • Point-of-care neurological assessment
  • Monitoring of hydrocephalus
  • Traumatic brain injury evaluation
  • Stroke assessment in acute settings
  • Post-operative brain imaging
  • Expanding MRI access in rural or underserved areas

What Physicians Need to Know

Evidence Base
The Swoop system is FDA-cleared for MRI of the brain and head for patients of all ages, including infants, and has received CE marking and UKCA approval. Its diagnostic capabilities are supported by clinical evidence and publications, with deep learning algorithms for image reconstruction and enhancement validated by independent expert radiologists and FDA-cleared. It is applicable for general brain imaging, including conditions such as headaches, stroke, non-specific muscle weakness, and encephalopathy.
Clinical Validation Studies
The NEURO PMR study demonstrated 92% concordance with standard MRI in identifying intracranial pathology (98% with clinical history) and showed patient preference for portable MRI. The ACTION PMR study indicated faster time-to-scan (median 2.5 hours vs. 27.7 hours for conventional MRI) and good specificity for acute stroke diagnosis, comparable to head CT. The SAFE MRI ECMO study highlighted its value for critically ill ICU patients on ECMO, where conventional MRI is often inaccessible. A retrospective analysis at Jefferson Abington Hospital showed positive economic impact, cost savings, and workflow efficiencies. A Contrast PMR study is ongoing to evaluate contrast-enhanced imaging. Clinical experience with over 500 patients supports its utility as an adjunct to high-field MRI, particularly for critically ill patients and those with certain medical devices due to its ultra-low-field environment.
Clinical Workflow Integration
The Swoop system is designed for point-of-care settings like ICUs, emergency departments, and mobile stroke units. Its portability allows bedside imaging, eliminating patient transport to traditional MRI suites, reducing delays, and minimizing transport-related adverse events. It operates via a standard electrical outlet and a wireless tablet, with trained clinical staff able to operate it with minimal training (e.g., 30 minutes). Images are displayed within minutes, facilitating rapid clinical decision-making.
Decision Audit Trail
The search results do not explicitly detail a 'decision audit trail' for physician decisions made with the tool. However, as a medical device, it would inherently log operational data, image acquisition parameters, and software processing information.
Physician Tip

Leverage the Swoop system for rapid, bedside brain imaging in critical care settings (ICU, ED, mobile stroke units) to reduce patient transport risks and delays in diagnosis and treatment. Utilize its portability for patients who are unstable or cannot be easily moved to a conventional MRI. Be aware that the system provides diagnostic-quality images for interpretation, and its AI-powered software enhances image quality, particularly for conditions like stroke. Consider its use in outpatient neurology clinics as a patient-preferred alternative to conventional MRI for certain conditions, as demonstrated by studies showing high concordance with standard MRI. Note that the ultra-low-field strength may allow scanning of patients with some active and passive medical devices that might be contraindicated for high-field MRI.

The Swoop system is designed for seamless integration into existing clinical workflows at the point of care. It operates independently with a standard electrical outlet and a wireless tablet for control. While it produces diagnostic images, direct integration with broader Electronic Health Record (EHR) systems for automated clinical decision support (e.g., triggering alerts or populating differential diagnoses) is not explicitly detailed in the provided information, beyond the images informing physician decisions. Its AI-powered software is integrated within the device for image reconstruction and enhancement.

Details

Category Clinical Decision Support & Reference, Neurology AI, Radiology & Imaging AI
Pricing Enterprise — Contact Hyperfine for enterprise pricing.
Free Trial No
DeploymentHybrid
Mobile AppIos
Data Export Yes
LanguagesEnglish
Training Yes
Target SizeHospitals, health systems, specialized clinics, emergency departments, ICUs
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated — Multiple 510(k) clearances, including K202860 for brain imaging.
Integrations
EHR Not specified
Specialties Emergency Medicine, General Surgery, Internal Medicine, Neurology, Pediatrics

Social Proof

Customers200+ systems deployed globally
Notable
Yale New Haven HospitalMount SinaiUniversity of PennsylvaniaChildren's Hospital of Philadelphia

Support & Reliability

Training Provided Yes

Ratings & Reviews

No reviews yet. Be the first to review this tool!

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Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

Medical Product Outsourcing
Indian Regulators Approve Hyperfine's Swoop System
Hyperfine Inc. has received regulatory approval from India's Central Drugs Standard Control Organization (CDSCO) for its Swoop Portable MR Imaging System, enabling commercialization throughout India. This approval expands Hyperfine's global reach into a significant healthcare market with unmet needs for advanced brain imaging.
2026-01
MarketScreener
Lioness Medtech AB And Hyperfine, Inc. Announce Peer-Reviewed Study Demonstrating Economic And Operational Impact Of Swoop Portable MR Imaging System In Acute Care Hospital Settings
A peer-reviewed study published in Clinical Neuroimaging, announced by Lioness Medtech AB and Hyperfine, Inc., demonstrates the significant economic and operational benefits of the Swoop Portable MR Imaging System in acute care settings. The study, conducted at Jefferson Abington Hospital, showed reduced MRI turnaround times, saved clinical labor hours, and substantial cost savings.
2026-07
PubMed
Clinical Use of the Swoop Portable MR Imaging System - PubMed
This video article provides an overview of the Swoop Portable MR Imaging System, highlighting its scanner characteristics, scan procedure, and representative clinical images from over 500 patients. It emphasizes the system's utility as an adjunct to high-field MRI for critically ill patients, reducing risks associated with transport and allowing imaging for patients with certain medical devices.
2025-10
Hyperfine, Inc. (Press Release)
Hyperfine Announces First Commercial Sales of Next-Gen Portable MRI System
Hyperfine Inc. announced the first commercial sales of its next-generation Swoop system to two leading U.S. hospitals, marking the launch of its AI-powered portable MR brain imaging. This new system features innovations for enhanced image quality and a user-centric design to accommodate a broad patient population.
2025-07
Xtalks
Optive AI Gets FDA Clearance, Elevates Image Quality for Swoop Portable MRI - Xtalks
The FDA has cleared Hyperfine Inc.'s Optive AI software, which significantly improves image clarity and anatomical detail for the Swoop Portable MR Imaging System. This clearance is expected to enhance diagnostic confidence and accelerate the adoption of the Swoop system in various clinical settings.
2025-05
AuntMinnie
Hyperfine, MUSC to use Swoop MR system on astronauts | AuntMinnie
Hyperfine is collaborating with the Medical University of South Carolina (MUSC) to use the Swoop Portable MR Imaging system to assess astronauts' brains before and after the Polaris Dawn mission. The goal is to study intracranial volume changes following spaceflight and re-adaptation to Earth.
2024-09
Applied Radiology
Study Shows Value of Portable MRI to Quickly Assess Stroke Patients - Applied Radiology
A multi-site observational study, with initial data from the ACTION PMR study, demonstrates the value of the Swoop Portable MR Imaging System in rapidly assessing stroke patients and guiding treatment decisions. The study, to be published in the August 2024 issue of the Annals of Neurology, showed encouraging results for stroke detection.
2024-07
Hyperfine, Inc. (Press Release)
Swoopu00ae Portable MR Imagingu00ae System Receives CE Marking - Hyperfine, Inc.
Hyperfine, Inc. announced that its Swoop Portable MR Imaging System with AI-powered imaging software has received CE Marking, indicating compliance with comprehensive new EU MDR regulations. This achievement opens opportunities for future commercial expansion into the European Economic Area.
2023-02

Videos

Product demos, reviews, and walkthroughs for Swoop® Portable MR Imaging® System.

View all on YouTube

Frequently Asked Questions

The Swoopu00ae system is primarily used for brain and head imaging in point-of-care settings such as intensive care units, emergency departments, mobile stroke units, and neurology offices. It is cleared for patients of all ages and aids in diagnosing conditions like stroke, traumatic brain injury, headaches, and encephalopathy, providing images within minutes at the patient's bedside.
The Swoopu00ae system is FDA 510(k) cleared for brain and head imaging of all ages and holds CE and UKCA certifications, allowing its use in numerous international markets. Its ultra-low magnetic field (0.064 Tesla) reduces safety concerns regarding metal objects and allows for use near other medical equipment without the need for extensive RF shielding.
While the Swoopu00ae system operates at an ultra-low field strength (0.064T) compared to conventional MRI, it provides diagnostic-quality images for specific clinical questions, enhanced by AI-powered software for improved clarity and consistency. Its primary limitation is its focus on brain imaging, and it is currently capable of non-contrast-enhanced imaging, though studies are underway to expand its capabilities with contrast agents.
Physicians should consider the Swoopu00ae system when a full diagnostic MRI is not clinically practical, desirable, or safe, such as for critically ill or unstable patients who cannot be transported to a traditional MRI suite. It offers a bedside imaging solution, avoiding transport risks and delays, and provides an alternative to CT scans by eliminating ionizing radiation, particularly beneficial in pediatric cases.
The Swoopu00ae system costs significantly less than traditional MRI machines, approximately $250,000 compared to over $1.5 million, and consumes substantially less power. It eliminates the need for costly shielded MRI rooms and can be acquired through purchase or a subscription model, offering potential savings by avoiding patient transport costs and increasing throughput.
Hyperfine is actively pursuing expanded capabilities for the Swoopu00ae system, including ongoing clinical studies to evaluate the feasibility and benefits of using gadolinium-based contrast agents for enhanced visualization of brain lesions. While currently focused on brain imaging, continuous software advancements, such as the Optive AIu2122 software, aim to improve image quality and diagnostic performance for conditions like stroke.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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