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Form 8-K Hyperfine, Inc. For: Oct 08

Thu, 08 Oct 2026 07:41:00 -0400

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Hyperfine posts record Q3 revenue of ~$6M, up 53% sequentially

Thu, 08 Oct 2026 07:31:15 -0400

Hyperfine, Inc. (Nasdaq: HYPR) reported preliminary, unaudited third-quarter 2026 revenue of approximately $6.0 million, representing 53% sequential growth compared to the second quarter of 2026, according to a company statement.

The Connecticut-based medical device maker said preliminary net cash burn, excluding financing proceeds, for the third quarter is expected to be approximately $5.6 million, a 29% sequential improvement. The company noted that no financing proceeds were raised during the quarter. For the first time, quarterly revenue is expected to exceed quarterly net cash burn.

Preliminary cash and cash equivalents as of September 30, 2026 are expected to be approximately $37.9 million, compared

Hyperfine posts record Q3 revenue of ~$6M, up 53% sequentially

Thu, 08 Oct 2026 07:31:15 -0400

Preliminary cash and cash equivalents as of September 30, 2026 are expected to be approximately $37.9 million, compared

Hyperfine Reports Record Preliminary Third Quarter Revenue of Approximately $6.0 Million & Reaffirms Full Year 2026 Revenue Outlook of Approximately $20 to $22 Million

Thu, 08 Oct 2026 07:30:00 -0400

Preliminary Revenue Represents 53% Sequential Quarterly Growth; Company Reaffirms 2026 Financial Guidance and Expects Quarter-End Cash and Cash Equivalents of Approximately $37.9 Million

“Our preliminary third-quarter results demonstrate that execution of our commercial strategy is driving meaningful growth. Momentum was strong across our three commercial verticals, with new

Hyperfine Reports Record Preliminary Third Quarter Revenue of Approximately $6.0 Million & Reaffirms Full Year 2026 Revenue Outlook of Approximately $20 to $22 Million

Thu, 08 Oct 2026 07:30:00 -0400

Preliminary Revenue Represents 53% Sequential Quarterly Growth; Company Reaffirms 2026 Financial Guidance and Expects Quarter-End Cash and Cash Equivalents of Approximately $37.9 Million

“Our preliminary third-quarter results demonstrate that execution of our commercial strategy is driving meaningful growth. Momentum was strong across our three commercial verticals, with new

Hyperfine, Inc. to Announce Third Quarter 2026 Financial Results on November 9, 2026

Thu, 08 Oct 2026 07:30:00 -0400

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 will report financial results for the third quarter 2026 on Monday, November 9, 2026. Management will host a corresponding conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.

A live audio webcast and an archive of the recording will be available through the Investors page of Hyperfine, Inc.’s corporate website at https://investors.hyperfine.io/. Participants are

Hyperfine, Inc. to Announce Third Quarter 2026 Financial Results on November 9, 2026

Thu, 08 Oct 2026 07:30:00 -0400

A live audio webcast and an archive of the recording will be available through the Investors page of Hyperfine, Inc.’s corporate website at https://investors.hyperfine.io/. Participants are

Hyperfine names distributor for portable brain MRI in Kuwait, UAE

Mon, 28 Sep 2026 08:15:52 -0400

Hyperfine, Inc. (Nasdaq: HYPR) has appointed Roots Pharmaceutical Co. W.L.L. as the exclusive distributor of its Swoop portable brain MRI system in Kuwait and the United Arab Emirates, according to a company statement.

Under the agreement, Roots Pharmaceutical will handle market development, local regulatory activities, product education, demonstrations, and customer engagement in both countries. Commercial and service activities are subject to applicable regulatory clearances in each market.

The Swoop system is FDA-cleared for brain imaging of patients of all ages. It is a portable, ultra-low-field MRI device designed to produce images of the internal structure of the head in settings where a

Hyperfine Expands Global Access to Portable Brain MRI Technology Across Key Gulf Cooperation Council Healthcare Markets

Mon, 28 Sep 2026 08:15:00 -0400

Hyperfine has appointed Roots Pharmaceutical as exclusive distributor of the Swoop® system for Kuwait and the United Arab Emirates

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 the appointment of Roots Pharmaceutical Co. W.L.L. as its exclusive distribution partner for Kuwait and the United Arab Emirates (UAE). Under the agreement, Roots Pharmaceutical will support market development, local regulatory activities, product education, demonstrations, customer engagement, and, following any applicable regulatory

Hyperfine Expands Global Access to Portable Brain MRI Technology Across Key Gulf Cooperation Council Healthcare Markets

Mon, 28 Sep 2026 08:15:00 -0400

Hyperfine has appointed Roots Pharmaceutical as exclusive distributor of the Swoop® system for Kuwait and the United Arab Emirates

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 the appointment of Roots Pharmaceutical Co. W.L.L. as its exclusive distribution partner for Kuwait and the United Arab Emirates (UAE). Under the agreement, Roots Pharmaceutical will support market development, local regulatory activities, product education, demonstrations, customer engagement, and, following any applicable regulatory

BTIG Reiterates Buy Rating on Hyperfine Inc. (HYPR)

Tue, 22 Sep 2026 06:03:52 -0400

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

The analyst commented: "Last week, we hosted Hyperfine CEO Maria Sainz and CFO Brett Hale for virtual investor meetings. With more than 200 systems deployed worldwide, HYPR's commercial story is progressing across all three channels: hospital, neurology office, and international. The hospital channel remains the dominant business. Utilization in hospitals is rising meaningfully and health systems are considering multi-unit and system-wide deployments. Management continues to report minimal pricing pushback, with a compelling ROI and demonstrated cost savings vs. conventional MRI. Momentum in the neurology

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

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

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