GUILFORD, Conn.--(BUSINESS WIRE)--Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—today announced results from the NEURO PMR study, presented by Dr. Laszlo Mechtler at the American Society of Neuroimaging (ASN) Annual Meeting in San Juan, Puerto Rico on January 16, 2026. From a clinical perspective, I have been impressed by the image quality delivered by the ...

Hyperfine Overview - Hyperfine's Swoop system is the first FDA-cleared, AI-powered portable MR brain imaging system, targeting a market opportunity exceeding $6 billion[4, 74] - The company's growth strategy is supported by the launch of the next-generation Swoop system and Optive AI software, which enhances image quality for ultra-low field MRI[4] - Hyperfine has secured approximately 200 patents related to its proprietary technology[9] Market and Expansion - The company is targeting expansion across multiple sites of care, including inpatient, outpatient, and community settings, with a total addressable market (TAM) potentially exceeding $16 billion[8] - Hyperfine has an installed base of over 190 Swoop systems globally[52] - The company estimates a potential US Swoop system revenue of $100 million for every 1.5% market penetration[54] Financial Performance - Q3 2025 revenue reached $3.4 million, representing a 27% sequential increase[58] - The effective average selling price (ASP) for the Swoop system in Q3 2025 was approximately $360,000[58] - Cash burn decreased to $5.9 million in Q3 2025, a 27% reduction compared to the previous quarter[59]

Core Insights - Hyperfine (HYPR) has received FDA 510(k) clearance for its next-generation Swoop Portable MR Imaging system, which utilizes proprietary OptiVu AI software to enhance image quality and usability [1][4][8] Company Developments - The FDA clearance enhances Hyperfine's commitment to bedside imaging, allowing for rapid, low-field MRI capabilities without the logistical challenges of traditional systems [2] - The Swoop system is designed to improve clinical utility and operational efficiency in hospitals and care teams, making it more competitive against conventional MRI systems [4][10] - The upgraded Swoop system features a new hardware platform and OptiVu AI software, providing the highest signal-to-noise ratio to date, resulting in exceptional image quality and faster acquisition times [9][10] - The system is tailored for a broad patient population, including pediatric and elderly patients, and is particularly beneficial in emergency departments and under-resourced locations [10][11] Market Position and Financials - Following the FDA announcement, HYPR's shares increased by 41%, closing at $0.85, although the company has seen a 3.4% decline year-to-date compared to a 9.7% decline in the industry [3] - Hyperfine currently has a market capitalization of $46.89 billion and has delivered an average earnings surprise of 3.1% over the trailing four quarters [5] Industry Outlook - The global portable MRI market is projected to grow from $4.34 billion in 2025 to around $7 billion by 2034, with a CAGR of 5.44% from 2024 to 2034, indicating a favorable market environment for Hyperfine's Swoop system [12]