Hyperfine, Inc. develops and commercializes the Swoop® system, an FDA-cleared, AI-powered portable ultra-low-field magnetic resonance brain imaging system. News about HYPR centers on Swoop deployments across hospitals, emergency departments, ICUs, neurology offices, and international markets; regulatory clearances such as CE and UKCA marks; and Optive AI™ software updates tied to brain imaging workflows.
Company updates also cover quarterly results, clinical data and publications in stroke and neuroimaging, distributor and customer activity, financing arrangements, and healthcare-conference participation.
Summary not available.
Summary not available.
Summary not available.
Summary not available.
Summary not available.
Hyperfine, Inc. (NASDAQ: HYPR), pioneer of the Swoop® system, the first FDA-cleared portable MRI system, announced it will report its Q1 2023 financial results on May 11, 2023. The company will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET to discuss the results. Swoop® provides neuroimaging at the point of care, offering bedside imaging capabilities where traditional MRI access is limited or unavailable. Initially cleared by the FDA in 2020, it is now also approved in Canada, Australia, and other regions, enhancing patient care through accessible diagnostic imaging. Interested investors can access the live audio webcast via the company’s website.
Hyperfine, Inc. (Nasdaq: HYPR) reported fourth quarter and full year 2022 financial results, achieving revenue of $6.8 million for the year, up from $1.5 million in 2021. In Q4 2022, revenue was $1.424 million, compared to $0.436 million in Q4 2021. The net loss for the year was $73.164 million, or $1.04 per share, an increase from $64.851 million or $17.57 per share in the previous year. The company ended the year with $117.472 million in cash. 2023 guidance estimates revenue between $10 to $14 million with a cash burn of $40 to $45 million. Significant achievements included FDA clearances and the installation of 35 commercial systems.
Hyperfine, Inc. (Nasdaq: HYPR), creator of the first FDA-cleared portable MRI system, Swoop®, announced it will report financial results for Q4 and full year 2022 on March 21, 2023. The management will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET, accessible through their investor page. The Swoop® system, approved for brain imaging in multiple countries, aims to enhance patient care through accessible diagnostic imaging. Since its FDA clearance in 2020, it has revolutionized neuroimaging by bringing bedside MRI capabilities to clinicians, improving diagnosis where conventional MRI is not feasible.
Hyperfine, Inc. (Nasdaq: HYPR) announced FDA 510(k) clearance for an updated version of its Swoop® Portable MR Imaging® system software, enhancing clinical utility in neurocritical care. The new software improves diffusion-weighted imaging (DWI) with a 42% increase in signal-to-noise ratio, essential for diagnosing neurological conditions. This update aims to provide clearer images and better patient care in diagnosing and monitoring stroke progression. The improved software is expected to roll out to customers in March 2023.
Hyperfine, Inc. (Nasdaq: HYPR) has achieved CE Marking for its portable MRI system with AI-powered imaging software, confirming compliance with EU safety standards. This milestone allows the company to explore future commercial opportunities within the European Economic Area (EEA) while maintaining its focus on the U.S. market in 2023. Compliance with the EU's Medical Device Regulation (MDR) was essential for legal marketing in Europe, reflecting an increase in regulatory rigor. CEO Maria Sainz emphasized the achievement's significance in enhancing the company's market potential.