Hyperfine Receives FDA Clearance for Two New Imaging Sequences
World’s first portable MRI with deep learning produces images in under three minutes with new Fast T2 scans
GUILFORD, CT – June 21, 2022 — Hyperfine, Inc., creator of the first FDA-cleared point of care magnetic resonance imaging (MRI) device, Swoop®, today announced the FDA 510(k) clearance and launch of new sequences that will expand the capabilities of the system, and allow shorter brain scan times for patients. The Swoop system’s software uses deep learning (DL) to deliver crisp, clear images that aid in clinical diagnosis.
“Hyperfine’s mission is to revolutionize patient care globally through accessible diagnostic imaging and actionable solutions,” relayed Dave Scott, Hyperfine CEO, “The clearance of this software upgrade, which includes 2 additional sequences, increases the capability of our point of care MRI system, supports our commitment to our customers to drive innovation in low field-portable MRI, and delivers product enhancements clinicians can use to improve patient care.”
Current MRI systems have many limitations – their large size, fixed location, high cost, and staff training requirements to name a few. Hyperfine has overcome these limitations by rethinking MRI design from the bottom up and adding smart computing. The result is Swoop, an easy-to-use, portable, and affordable brain imaging system costing less than the annual service contract of many conventional MRI systems.
This FDA submission included clearance for two additional sequences.
- T1 Standard Sequence - This adds a new T1 sequence that is optimized for imaging inside the brain, which complements the existing T1 Gray/White sequence optimized for imaging the surface of the brain.
- Fast T2 Sequence - Enables acquisition in half the time for patients who may have difficulty staying still without sedation. This sequence provides clinically relevant images to aid in the assessment of brain ventricles.
"We are resolute on expanding the toolbox available to our clinicians with continuous software upgrades that will make point of care MRI a reality for a growing number of patients," said Tom Teisseyre, Hyperfine Chief Product Officer. “Enhancements like this are core to our innovative approach to MR imaging, and we are committed to leveraging software advancements, deep learning, and artificial intelligence to continuously improve the Swoop platform.”
For more information about the Hyperfine Swoop® Portable MR Imaging SystemTM, please visit http://www.hyperfine.io.
About Hyperfine and the Swoop® Portable MRI SystemTM
Hyperfine, Inc. is the groundbreaking medical device company that created Swoop, the world’s first US FDA-cleared portable MRI system. Hyperfine designed Swoop to enable rapid diagnosis and treatment of all patients regardless of income, resources, or location, pushing the boundaries of conventional imaging technology and expanding patient access to life-saving care. The Swoop Portable MR Imaging System produces high-quality images at a lower magnetic field strength, allowing clinicians to quickly scan, diagnose and treat patients in various point-of-care clinical settings. Swoop can be wheeled directly to the patient’s bedside, plugged into a standard electrical wall outlet, and controlled by a tablet. Designed as a complementary system to conventional MRIs at a fraction of the cost, Swoop captures images in minutes, providing critical decision-making capabilities across a variety of clinical settings. For more information about Hyperfine, please visit https://www.hyperfine.io.
This presentation includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Hyperfine’s actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, Hyperfine’s expectations with respect to financial results, future performance, development and commercialization of products and services, the potential benefits and impact of Hyperfine’s products and services, potential regulatory approvals, and the size and potential growth of current or future markets for Hyperfine’s products and services. Most of these factors are outside of Hyperfine’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the completion and audit of Hyperfine’s financial statements for the year ended December 31, 2021; the success, cost and timing of Hyperfine product development and commercialization activities, including the degree that Swoop is accepted and used by healthcare professionals; the impact of COVID-19 on Hyperfine’s business; the inability to maintain the listing of Hyperfine’s Class A common stock on the Nasdaq following the recently completed business combination; the inability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition and Hyperfine’s ability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of Hyperfine to raise financing in the future; the inability of Hyperfine to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of Hyperfine to identify, in-license or acquire additional technology; the inability of Hyperfine to maintain its existing or future license, manufacturing, supply and distribution agreements; the inability of Hyperfine to compete with other companies currently marketing or engaged in the development of products and services that Hyperfine is currently marketing or developing; the size and growth potential of the markets for Hyperfine’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of Hyperfine’s products and services and reimbursement for medical procedures conducted using Hyperfine’s products and services; Hyperfine’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; Hyperfine’s financial performance; and other risks and uncertainties indicated from time to time in Hyperfine’s filings with the Securities and Exchange Commission, including those under “Risk Factors” therein. Hyperfine cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements, which speak only as of the date made. Hyperfine does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.