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Hyperfine's (HYPR) Swoop System Gets New FDA-Cleared Software
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Hyperfine (HYPR - Free Report) recently announced the receipt of FDA 510(k) clearance for the ninth generation of its AI-powered Swoop system software. It is the world’s first FDA-cleared portable magnetic resonance (MR) brain imaging system. The advanced software significantly reduces scan times across multiple MR sequences without sacrificing image quality.
With the launch of the ninth-generation AI-powered software, Hyperfine keeps expanding the Swoop system's clinical utility and workflow fit. In acute care settings, when prompt and accurate information is crucial for making the best decisions for patients, striking a balance between speed and picture quality is important.
More on the New Software
The FDA-approved advanced software has the potential to shorten scan times for several MR sequences without sacrificing image quality. In acute care settings, where every second counts, these scan time reductions may allow Swoop system pictures to aid in expediting the diagnostic process. This is especially important for time-sensitive medical illnesses like stroke. The detrimental effects of patient movements on image quality can also be lessened by cutting down on the total acquisition time for sequences.
Timely MR brain imaging is essential for clinicians making critical treatment decisions, particularly in acute neurological episodes like strokes. The Acute Ischemic Stroke Detection with Portable MR (ACTION PMR) study assesses the use of the Swoop system in stroke diagnosis. This latest software is likely to help the Swoop system more seamlessly integrate into stroke workflows.
The FDA's Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices list shows how committed Hyperfine is to using AI to advance ultra-low-field portable MR brain imaging technology and enhance patient care, as evidenced by the total number of marketing authorizations that Hyperfine has received with AI support.
More on the ACTION PMR Study
The ACTION PMR study is a prospective, international, multi-site observational study aimed at examining the integration of brain imaging with the portable Swoop system into the stroke diagnosis and treatment workflow.
ACTION PMR has enrolled more than 100 patients at four institutions and consists of a series of investigator-sponsored studies. The initial 100 patients allow for a direct comparison of stroke detection between ultra-low-field Magnetic resonance imaging (MRI), conventional high-field MRI, and computed tomography to assess the capability of stroke detection in the Swoop system.
The study will continue into a workflow phase starting later this year, evaluating the ease of access and versatility of using the Swoop system in emergency departments and stroke centers within hospital networks.
More on the Swoop System
The Swoop Portable MR Imaging system received FDA clearance for brain imaging of patients of all ages. It is a portable, ultra-low-field magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical.
The images provide information that can help with diagnosis when interpreted by a medical professional with the necessary training. Additionally, the Swoop system is certified by the UKCA in the United Kingdom and has already received the CE mark in the European Union. The Swoop system is commercially available in a select number of international markets.
Industry Prospects
Per a report by Coherent Market Insights, the global neuroimaging market size was estimated to be $37.63 billion in 2023 and is expected to reach $56.58 billion by 2030 at a growth rate of 6%.
One of the main factors propelling the market for brain imaging and neuroimaging growth is the rising prevalence of neurological disorders. The increasing frequency of these disorders results in the increased need for brain imaging services caused by several variables.
Price Performance
In the year-to-date period, HYPR’s shares have gained 7.1% compared with the industry’s rise of 5.2%. The S&P 500 increased 16.1% in the same time frame.
Image Source: Zacks Investment Research
Zacks Rank & Stocks to Consider
HYPR carries a Zacks Rank #3 (Hold) at present.
Some better-ranked stocks in the broader medical space that have announced quarterly results are Elevance Health, Inc. (ELV - Free Report) , Hologic (HOLX - Free Report) and Universal Health Services (UHS - Free Report)
Elevance Health, carrying a Zacks Rank of 2 (Buy) at present, has an estimated long-term growth rate of 12.2%. ELV’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 2.8%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Elevance Health’s shares have rallied 22.1% compared with the industry’s 5.5% rise in the past year.
Hologic, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 7.4%. Its earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 4.94%.
Hologic’s shares have risen 0.3% year to date compared with the industry’s 4.7% growth.
Universal Health Services has an Earnings ESP of +2.91% and a Zacks Rank of 2, at present. UHS has an estimated earnings growth rate of 30.5% for 2024.
UHS’ earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 8.12%.
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Hyperfine's (HYPR) Swoop System Gets New FDA-Cleared Software
Hyperfine (HYPR - Free Report) recently announced the receipt of FDA 510(k) clearance for the ninth generation of its AI-powered Swoop system software. It is the world’s first FDA-cleared portable magnetic resonance (MR) brain imaging system. The advanced software significantly reduces scan times across multiple MR sequences without sacrificing image quality.
With the launch of the ninth-generation AI-powered software, Hyperfine keeps expanding the Swoop system's clinical utility and workflow fit. In acute care settings, when prompt and accurate information is crucial for making the best decisions for patients, striking a balance between speed and picture quality is important.
More on the New Software
The FDA-approved advanced software has the potential to shorten scan times for several MR sequences without sacrificing image quality. In acute care settings, where every second counts, these scan time reductions may allow Swoop system pictures to aid in expediting the diagnostic process. This is especially important for time-sensitive medical illnesses like stroke. The detrimental effects of patient movements on image quality can also be lessened by cutting down on the total acquisition time for sequences.
Timely MR brain imaging is essential for clinicians making critical treatment decisions, particularly in acute neurological episodes like strokes. The Acute Ischemic Stroke Detection with Portable MR (ACTION PMR) study assesses the use of the Swoop system in stroke diagnosis. This latest software is likely to help the Swoop system more seamlessly integrate into stroke workflows.
The FDA's Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices list shows how committed Hyperfine is to using AI to advance ultra-low-field portable MR brain imaging technology and enhance patient care, as evidenced by the total number of marketing authorizations that Hyperfine has received with AI support.
More on the ACTION PMR Study
The ACTION PMR study is a prospective, international, multi-site observational study aimed at examining the integration of brain imaging with the portable Swoop system into the stroke diagnosis and treatment workflow.
ACTION PMR has enrolled more than 100 patients at four institutions and consists of a series of investigator-sponsored studies. The initial 100 patients allow for a direct comparison of stroke detection between ultra-low-field Magnetic resonance imaging (MRI), conventional high-field MRI, and computed tomography to assess the capability of stroke detection in the Swoop system.
The study will continue into a workflow phase starting later this year, evaluating the ease of access and versatility of using the Swoop system in emergency departments and stroke centers within hospital networks.
More on the Swoop System
The Swoop Portable MR Imaging system received FDA clearance for brain imaging of patients of all ages. It is a portable, ultra-low-field magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical.
The images provide information that can help with diagnosis when interpreted by a medical professional with the necessary training. Additionally, the Swoop system is certified by the UKCA in the United Kingdom and has already received the CE mark in the European Union. The Swoop system is commercially available in a select number of international markets.
Industry Prospects
Per a report by Coherent Market Insights, the global neuroimaging market size was estimated to be $37.63 billion in 2023 and is expected to reach $56.58 billion by 2030 at a growth rate of 6%.
One of the main factors propelling the market for brain imaging and neuroimaging growth is the rising prevalence of neurological disorders. The increasing frequency of these disorders results in the increased need for brain imaging services caused by several variables.
Price Performance
In the year-to-date period, HYPR’s shares have gained 7.1% compared with the industry’s rise of 5.2%. The S&P 500 increased 16.1% in the same time frame.
Image Source: Zacks Investment Research
Zacks Rank & Stocks to Consider
HYPR carries a Zacks Rank #3 (Hold) at present.
Some better-ranked stocks in the broader medical space that have announced quarterly results are Elevance Health, Inc. (ELV - Free Report) , Hologic (HOLX - Free Report) and Universal Health Services (UHS - Free Report)
Elevance Health, carrying a Zacks Rank of 2 (Buy) at present, has an estimated long-term growth rate of 12.2%. ELV’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 2.8%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Elevance Health’s shares have rallied 22.1% compared with the industry’s 5.5% rise in the past year.
Hologic, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 7.4%. Its earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 4.94%.
Hologic’s shares have risen 0.3% year to date compared with the industry’s 4.7% growth.
Universal Health Services has an Earnings ESP of +2.91% and a Zacks Rank of 2, at present. UHS has an estimated earnings growth rate of 30.5% for 2024.
UHS’ earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 8.12%.