Advanced artificial intelligence (AI) algorithms are now
integrated across all Swoop® ultra-low-field brain imaging system
sequences
Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical
device company that has redefined brain imaging with the world’s
first FDA-cleared portable magnetic resonance brain imaging
system—the Swoop® system—today announced FDA clearance of updated
software. Built on a robust AI foundation, the latest software
brings image quality enhancements to the Swoop® system’s
diffusion-weighted imaging (DWI) sequence.
With this latest software update, Hyperfine, Inc. expands the
Swoop® system’s AI denoising capabilities by incorporating advanced
image post-processing into the DWI sequence. The system’s other
sequences (T1, T2, and FLAIR) previously benefited from this AI
feature. Denoising enables a crisper image that potentially helps
clinicians more accurately diagnose, treat, and monitor patients
undergoing brain imaging.
“We believe in making brain imaging more accessible, clinically
relevant, and actionable. We continue to make meaningful progress
across all sequences. With this significant and most recent update,
we now incorporate deep learning into our DWI sequence,” said Tom
Teisseyre, chief operating officer of Hyperfine, Inc. “These
imaging improvements will serve a critical role in enhancing image
quality for healthcare professionals in time-sensitive
environments.”
Maria Sainz, president and CEO of Hyperfine, Inc., remarked,
“Our eighth FDA software clearance in three years for the Swoop®
system underscores our relentless drive for innovation and
continuous improvement. Our focus remains on providing quality
brain imaging to more providers and patients in more sites of care.
More than milestones, it's about reshaping patient care, empowering
clinicians, and advancing brain imaging.”
Hyperfine, Inc. will roll out the updated Swoop® system software
in the coming months.
For more information about the Swoop® Portable MR Imaging®
System, please visit hyperfine.io.
About Hyperfine, Inc. and the Swoop® Portable MR Imaging®
System
Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking medical
technology company that has redefined brain imaging with the Swoop®
system—the world’s first FDA-cleared, portable, ultra-low-field,
magnetic resonance brain imaging system capable of providing
imaging at multiple points of care. The Swoop® system received
initial U.S. Food and Drug Administration (FDA) clearance in 2020
as a portable magnetic resonance brain imaging device for producing
images that display the internal structure of the head where a full
diagnostic examination is not clinically practical. When
interpreted by a trained physician, these images provide
information that can be useful in determining a diagnosis. The
Swoop® system has been approved for brain imaging in several
countries, including Canada and Australia, has UKCA certification
in the United Kingdom, CE certification in the European Union, and
is also available in New Zealand.
The mission of Hyperfine, Inc. is to revolutionize patient care
globally through transformational, accessible, clinically relevant
diagnostic imaging and data solutions. Founded by Dr. Jonathan
Rothberg in a technology-based incubator called 4Catalyzer,
Hyperfine, Inc. scientists, engineers, and physicists developed the
Swoop® system out of a passion for redefining brain imaging
methodology and how clinicians can apply accessible diagnostic
imaging to patient care. Traditionally, access to costly,
stationary, conventional MRI technology can be inconvenient or not
available when needed most. With the portable, ultra-low-field
Swoop® system, Hyperfine, Inc. is redefining the neuroimaging
workflow by bringing brain imaging to the patient’s bedside. For
more information, visit hyperfine.io.
Hyperfine, Swoop, and Portable MR Imaging are registered
trademarks of Hyperfine, Inc.
Forward-Looking Statements
This press release includes “forward-looking statements” within
the meaning of the “safe harbor” provisions of the Private
Securities Litigation Reform Act of 1995. Actual results of
Hyperfine, Inc. (the “Company”) 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, the Company’s goals and commercial plans, the benefits
of the Company’s products and services, and the Company’s future
performance and its ability to implement its strategy. These
forward-looking statements involve significant risks and
uncertainties that could cause the actual results to differ
materially from the expected results. Most of these factors are
outside of the Company’s control and are difficult to predict.
Factors that may cause such differences include, but are not
limited to: the success, cost and timing of the Company’s product
development and commercialization activities, including the degree
that the Swoop® system is accepted and used by healthcare
professionals; the impact of COVID-19 on the Company’s business;
the inability to maintain the listing of the Company’s Class A
common stock on the Nasdaq; the Company’s inability to grow and
manage growth profitably and retain its key employees; changes in
applicable laws or regulations; the inability of the Company to
raise financing in the future; the inability of the Company 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 the Company to
identify, in-license or acquire additional technology; the
inability of the Company to maintain its existing or future
license, manufacturing, supply and distribution agreements and to
obtain adequate supply of its products; the inability of the
Company to compete with other companies currently marketing or
engaged in the development of products and services that the
Company is currently marketing or developing; the size and growth
potential of the markets for the Company’s products and services,
and its ability to serve those markets, either alone or in
partnership with others; the pricing of the Company’s products and
services and reimbursement for medical procedures conducted using
the Company’s products and services; the Company’s estimates
regarding expenses, revenue, capital requirements and needs for
additional financing; the Company’s financial performance; and
other risks and uncertainties indicated from time to time in
Company’s filings with the Securities and Exchange Commission,
including those under “Risk Factors” therein. The Company 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.
The Company 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20231009561393/en/
Media Contact Jessica Stebing Health+Commerce
jstebing@healthandcommerce.com
Investor Contact Marissa Bych Gilmartin Group LLC
marissa@gilmartinir.com
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