Hyperfine Stock Rises After FDA Clears Next-Gen Swoop MRI System

Hyperfine HYPR recently announced FDA 510(k) clearance for its next-generation Swoop Portable MR Imaging system. The clearance covers an entirely new portable magnetic resonance imaging (MRI) scanner powered by Hyperfine’s proprietary OptiVu AI software, delivering the company’s highest level of image quality, functionality, and usability to date.The FDA clearance strengthens Hyperfine’s commitment to revolutionizing bedside imaging by enabling rapid, low-field MRI capabilities without the logistical hurdles of traditional systems. With enhanced workflow, usability, and advanced AI-driven imaging, the next-gen Swoop system is positioned to bring greater clinical utility and operational efficiency to hospitals and care teams.Likely Trend of HYPR Stock Following the NewsFollowing the announcement, shares of the company moved 41% north and closed at $0.85 on Monday’s closing. Shares of the company have lost 3.4% in the year-to-date period compared with the industry’s 9.7% decline. The S&P 500 has gained 0.4% in the same time frame.This FDA clearance positions Hyperfine for long-term growth by significantly enhancing the clinical appeal and marketability of its Swoop system, enabling broader adoption across hospitals, emergency departments, and global health systems. The improved image quality, AI-driven diagnostics, and ease of use make the system more competitive against conventional MRI, potentially accelerating sales, expanding reimbursement opportunities, and opening new revenue streams.HYPR currently has a market capitalization of $46.89 billion. In the trailing four quarters, HYPR delivered an average earnings surprise of 3.1%.Image Source: Zacks Investment ResearchMore on the Next-Generation Swoop SystemThe newly FDA-cleared next-generation Swoop Portable MR Imaging system represents a major technological advancement in bedside brain imaging. The system features a newly engineered hardware platform combined with the proprietary Optive AI software. This integration delivers the highest signal-to-noise ratio to date, resulting in exceptional image quality with improved resolution, uniformity, and faster acquisition times. These enhancements are designed to meet the growing demand for high-performance imaging solutions in varied healthcare environments where traditional MRI access is limited or delayed.The upgraded Swoop system is tailored to be user- and patient-centric. It is optimized to scan a broad patient population, including pediatric, elderly, or anxious individuals, making it highly valuable in settings where patient compliance and comfort are crucial. Its compact, mobile design eliminates the need for patient transport, enabling clinicians to acquire brain scans directly at the point of care. This capability is particularly beneficial in emergency departments, ICUs, neurology offices, and even rural or under-resourced locations.The system's development was shaped through collaboration with leading institutions such as Jefferson Abington, and is actively used in the Hyperfine-sponsored NEURO PMR study. Early results from these studies report highly positive feedback from clinicians and patients alike, with notable improvements in diagnostic efficiency and patient comfort.Favorable Industry Prospects for HYPRPer a report by Precedence Research, the global portable MRI market size accounted for $4.34 billion in 2025, and is expected to be worth around $7 billion by 2034, registering a CAGR of 5.44% between 2024 and 2034.Given the market potential, HYPR is likely to witness a boost in its imaging business with the FDA-cleared Swoop system.HYPR’s Zacks Rank & Key PicksCurrently, HYPR carries a Zacks Rank #3 (Hold).Some better-ranked stocks in the broader medical space that have announced quarterly results are CVS Health Corporation CVS, Integer Holdings Corporation ITGR and AngioDynamics ANGO.CVS Health, carrying a Zacks Rank of 2 (Buy), reported first-quarter 2025 adjusted earnings per share (EPS) of $2.25, beating the Zacks Consensus Estimate by 31.6%. Revenues of $94.59 billion outpaced the consensus mark by 1.8%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.CVS Health has a long-term estimated growth rate of 11.4%. CVS’s earnings surpassed estimates in each of the trailing four quarters, with an average surprise of 18.1%.Integer Holdings reported first-quarter 2025 adjusted EPS of $1.31, beating the Zacks Consensus Estimate by 3.2%. Revenues of $437.4 million surpassed the Zacks Consensus Estimate by 1.3%. It currently sports a Zacks Rank #1.Integer Holdings has a long-term estimated growth rate of 18.4%. ITGR’s earnings surpassed estimates in three of the trailing four quarters and missed once, the average surprise being 2.8%.AngioDynamics, currently sporting a Zacks Rank #1, reported a third-quarter fiscal 2025 adjusted EPS of 3 cents against the Zacks Consensus Estimate of a 13-cent loss. Revenues of $72 million beat the Zacks Consensus Estimate by 2%.ANGO has an estimated fiscal 2026 earnings growth rate of 27.8% compared with the S&P 500 Composite’s 10.5% growth. The company surpassed earnings estimates in each of the trailing four quarters, with the average surprise being 70.9%.Zacks' Research Chief Names "Stock Most Likely to Double"Our team of experts has just released the 5 stocks with the greatest probability of gaining +100% or more in the coming months. Of those 5, Director of Research Sheraz Mian highlights the one stock set to climb highest.This top pick is among the most innovative financial firms. With a fast-growing customer base (already 50+ million) and a diverse set of cutting edge solutions, this stock is poised for big gains. Of course, all our elite picks aren’t winners but this one could far surpass earlier Zacks’ Stocks Set to Double like Nano-X Imaging which shot up +129.6% in little more than 9 months.Free: See Our Top Stock And 4 Runners UpWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AngioDynamics, Inc. (ANGO): Free Stock Analysis Report CVS Health Corporation (CVS): Free Stock Analysis Report Integer Holdings Corporation (ITGR): Free Stock Analysis Report Hyperfine, Inc. (HYPR): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks