FDA OKs Hyperfine's image reconstruction software

By AuntMinnie.com staff writers

November 29, 2021 -- The U.S. Food and Drug Administration (FDA) has cleared portable MRI developer Hyperfine's new advanced image reconstruction technology using deep learning.

The 510(k) clearance builds upon prior clearance of its artificial intelligence (AI) technology, which automatically measures ventricular volume, brain extraction, brain alignment, and midline shift. With deep learning-based advanced image reconstruction, the quality of T1, T2, and fluid-attenuated inversion-recovery (FLAIR) images from its Swoop portable MRI device has improved, according to Hyperfine.

In other company news, the Securities and Exchange Commission (SEC) said the registration statement on Form S-4 in connection with combining Hyperfine, Liminal Sciences, and HealthCor Catalio Acquisition, a special purpose acquisition company, is effective.

Back in July, Hyperfine announced its plans to go public with the listing of the company's shares on the Nasdaq stock exchange under the name "Hyperfine, Inc." and teamed up with Liminal Sciences and HealthCor to do so.

Later this month, HealthCor shareholders will meet to approve, among other things, the proposed business combination. HealthCor filed with the SEC a definitive proxy statement/prospectus relating to the special meeting and will begin mailing it to shareholders in the coming days.


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