IndustryCompany release

Hyperfine Q3 revenue rises 73% to $6.0M on 14 Swoop portable MRI sales

🇺🇸 Hyperfine, Inc. (HYPR) · Mon 09 Nov 2026

The portable MRI maker narrowed its quarterly loss to $6.0 million, kept 2026 revenue guidance and flagged an FDA submission for its Contrast PMR study by year-end.

Hyperfine (Nasdaq: HYPR) reported third-quarter 2026 results on 9 November, with revenue up 73% year on year to $6.0 million. The company sold 14 Swoop portable brain MRI systems in the period and posted a net loss of $6.0 million.

On the regulatory side, Hyperfine noted FDA clearance and CE/UKCA marking for its latest Optive AI software. It also launched Model 2 in Europe and the UK.

The company has completed enrolment in its Contrast PMR study and expects to make an FDA submission by the end of 2026. The summary does not specify the regulatory pathway or the intended indication, and no further study details were available.

Hyperfine maintained its 2026 revenue guidance of $20-22 million. It also plans a new $150 million shelf registration to replace the existing one, which expires in November 2026.

What it means for your team

  • Regulatory teams tracking AI-enabled imaging software can note that Optive AI now carries FDA clearance as well as CE and UKCA marking.
  • An FDA submission from the Contrast PMR study is expected by end of 2026; the submission type and indication were not given in the material available.
  • The Model 2 launch in Europe and the UK may be relevant to market-access teams assessing portable MRI adoption in those markets.

Company's press release (SEC filing): Hyperfine, Inc. ↗

Article written by VigiEye from the official source (Hyperfine, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

More Industry All →