Hyperfine Inc.

Hyperfine has completed patient recruitment for the multicenter “Contrast PMR” study using the portable Swoop ultra-low-field MRI. The study evaluates the depiction of gadolinium-based contrast-enhancing brain lesions, in particular tumors and inflammatory diseases, across three imaging endpoints. After analyzing the images, the company plans to submit a 510(k) application to the FDA by the end of 2026 to expand the indications of the Swoop system. » More on de.investing.com

Hyperfine says that in the first twelve months after market launch over 3,000 brain MRI scans were performed with the portable Swoop system in outpatient clinics. The prospective NEURO-PMR study showed 92% concordance for detecting structural abnormalities compared with high-field MRI, rising to 98% when clinical information was included. Patients preferred the portable system four to one over high-field MRI; the FDA-cleared ultra-low-field system can be used in standard exam rooms without shielding and operated by trained clinic staff. » More on de.investing.com

According to a preliminary list from FTSE Russell, Hyperfine is expected to be added to the Russell 3000—and therefore also to the Russell 2000—effective after market close on June 26, 2026. The decision follows the annual reconstitution based on market capitalization and style attributes. Hyperfine has recently posted strong share gains (173% last year, +52% in 2026) and remains unprofitable with a market capitalization of $146.8 million and $15.33 million in revenue over the last twelve months, but has more cash than debt. » More on de.investing.com