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Form 8-K Hyperfine, Inc. For: Sep 17

Fri, 18 Sep 2026 16:08:00 -0400

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Hyperfine completes enrollment in contrast MRI study for Swoop system

Tue, 15 Sep 2026 08:16:04 -0400

Hyperfine, Inc. (Nasdaq: HYPR) has completed enrollment in the Contrast PMR study, a prospective, multi-center clinical trial evaluating the use of contrast agents with its Swoop portable MRI system, according to a company statement.

The study is designed to assess the visualization of brain lesions, including those associated with blood-brain barrier disruption, using gadolinium-based contrast agents with ultra-low-field portable MRI. Visualization is evaluated across three endpoints related to lesion appearance.

Hyperfine said it plans to use the study data to support a 510(k) submission to the U.S. Food and Drug Administration, which the company intends to file by the end of 2026.

Hyperfine Announces Completion of Enrollment in the Contrast PMR Study to Support the Submission to Expand Indications for Use of the Swoop® System with Contrast Agents

Tue, 15 Sep 2026 08:15:00 -0400

The anticipated indication expansion would position Hyperfine to drive adoption in outpatient neurology and establish new opportunities for portable MRI in post-procedural imaging in operating room workflows.

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 that it has completed enrollment of the Contrast PMR study, a prospective, multi-center clinical study designed to evaluate the feasibility and visualization benefits of contrast-enhanced ultra-low-field portable MRI using the Swoop system. The study is

Hyperfine Announces Completion of Enrollment in the Contrast PMR Study to Support the Submission to Expand Indications for Use of the Swoop® System with Contrast Agents

Tue, 15 Sep 2026 08:15:00 -0400

BTIG Reiterates Buy Rating on Hyperfine Inc. (HYPR)

Mon, 14 Sep 2026 06:09:48 -0400

BTIG analyst Marie Thibault reiterated a Buy rating and $2.00 price target on Hyperfine Inc. (NASDAQ: HYPR).

The analyst commented: "Later this week, we will be hosting virtual investor meetings with Hyperfine CEO Maria Sainz and CFO Brett Hale. HYPR is coming off a solid Q2, having sold 12 Swoop systems during the quarter, above our 10-unit estimate and reporting revenue roughly in line with consensus. Guidance was reiterated at $20M-$22M for FY26. Following the Q2 print, the company received its second FDA-cleared AI software update since the mid-2025 launch of Model 2 (see note here). The new Optive AI package

Hyperfine reports 3,000 scans and study results in office MRI push

Wed, 26 Aug 2026 08:16:13 -0400

Hyperfine, Inc. (Nasdaq: HYPR) announced the peer-reviewed publication of the NEURO PMR study in the Journal of Neuroimaging, alongside a milestone of more than 3,000 brain MRI scans completed in outpatient settings during the first year of its office-market launch.

The NEURO PMR study, described as the first prospective, multicenter, real-world study comparing portable MRI to high-field MRI in outpatient neurology clinics, found that portable MRI demonstrated 92% concordance with high-field MRI in identifying the presence or absence of structural abnormality in blinded neuroradiology review, rising to 98% when clinical information was included. Patients reported preferring portable MRI over high-field MRI

Hyperfine Builds Momentum in Year One of Neurology Office Launch with NEURO PMR Publication and More Than 3,000 Scans

Wed, 26 Aug 2026 08:15:00 -0400