Hyperfine is deploying its software in the EEA, following FDA clearance, and is used by Simona Sacco for stroke triage.
5 reports, 2 independent
Updated Jul 1
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New informationRepeats or wire copies
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What happened
Hyperfine is deploying its software in the EEA, following FDA clearance, and is used by Simona Sacco for stroke triage.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.- FDA cleared Hyperfine's AI-powered portable MRI system.Sub-event
Hyperfine's software receives FDA clearance and is being deployed in the European Economic Area.1 source
FDA cleared Hyperfine's Swoop system for brain imaging.1 source
FDA clearance allows Hyperfine to begin commercial sales of its software.1 source
Keep exploring
The entities involved
- FDA
-
European Economic Area
area of the European Union's internal market and some of EFTA states established in 1994
Related events
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- The Maharashtra Public Service Commission (MPSC) utilized an exam paper provided by the FDA.
Coverage
Newest first; wire copies grouped- Business WireHyperfine Receives CE Mark and UKCA Approval for Optive AI™ Software, Expanding Global Commercialization of Latest AI-Powered Imaging Software Approvals mark a major milestone and bring the most adva
- Business WireHyperfine, Inc. to Participate in Upcoming Investor Conferences GUILFORD, Conn., August 25, 2025--(BUSINESS WIRE)--Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that ha
- GlobeNewswireHyperfine, Inc. Reports Second Quarter 2025 Financial Results GUILFORD, Conn., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has
- Business WireHyperfine Announces the First Commercial Sales of the Next-Generation Swoop® System Powered by Optive AI™ Software Following the recent clearance of the new Swoop® System, two leading hospitals in th